Microdent Ektos Implant System
Device Facts
| Record ID | K153650 |
|---|---|
| Device Name | Microdent Ektos Implant System |
| Applicant | Implants Microdent System S.L |
| Product Code | DZE · Dental |
| Decision Date | May 20, 2016 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3640 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
Microdent Ektos Implant System is indicated for surgical placement in the upper or lower jaw arches, for single-stage or two-stage surgical procedures and cemented, screw retained restorations or overdentures. Microdent Ektos Implant System is intended for immediate placement and function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Small diameter implants are indicated only for replacement of central and lateral incisors in the maxilla and mandible.
Device Story
Microdent Ektos Implant System consists of endosseous dental implants and prosthetic components (abutments, cover screws, healing abutments). Implants are machined from commercially pure titanium (Grade 4) with a blasted surface finish; abutments are titanium alloy (Grade 5). The system features an internal hexagonal connection. Used by dental surgeons in clinical settings for single-stage or two-stage procedures. Implants are placed at the crestal bone level. The device restores chewing function by supporting crowns, bridges, or overdentures. The healthcare provider selects components based on patient anatomy and restoration type. The system supports both deferred and immediate loading techniques. Benefits include restoration of oral function and aesthetics for edentulous or partially edentulous patients.
Clinical Evidence
No clinical testing was performed. Substantial equivalence is supported by non-clinical bench testing, including static and dynamic fatigue testing (ISO 14801), sterilization validation (ISO 11137), biocompatibility (ISO 10993-1, ISO 10993-5), package integrity (ASTM F-1980-07), and surface analysis (ESEM, EDS, TOC).
Technological Characteristics
Materials: Commercially pure titanium (Grade 4, ISO 5832-2) for implants; Ti-6Al-4V-ELI alloy (Grade 5, ISO 5832-3) for abutments. Design: Threaded, root-form endosseous implants with internal hexagonal connection. Surface: Blasted (0.82 μm roughness). Sterilization: Gamma irradiation. Packaging: Sterile barrier system (vial/sleeve).
Indications for Use
Indicated for patients requiring dental implants in upper or lower jaw arches for single or two-stage surgical procedures, including cemented/screw-retained restorations or overdentures. Supports immediate placement and function for single or multiple tooth applications given adequate primary stability and occlusal loading. Small diameter implants restricted to replacement of central and lateral incisors in maxilla and mandible.
Regulatory Classification
Identification
An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.
Special Controls
*Classification.* (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2) *Classification.* Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use; (ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads; (iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system; (iv) The device must be demonstrated to be biocompatible; (v) Sterility testing must demonstrate the sterility of the device; (vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment; (vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians; (viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and (ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
Predicate Devices
- Legacy System Dental Implants (K073033)
- Microdent Genius Implant System (K141188)
- Legacy Abutment System (K060063)
Submission Summary (Full Text)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 20, 2016
Implants Microdent System S.L Mr. Jordi Clapés Donadeu Quality Director C/ Carles Buigas, I-Can Magre Santa Eulalia de Roncana, Barcelona 08187 SPAIN
Re: K153650
Trade/Device Name: Microdent Ektos Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: April 11, 2016 Received: April 18, 2016
Dear Mr. Donadeu:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours, Tina Kiang ਦੇ
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
### Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K153650
Device Name Microdent Ektos Implant System
### Indications for Use (Describe)
Microdent Ektos Implant System is indicated for surgical placement in the upper or lower jaw arches, for single-stage or two-stage surgical procedures and cemented, screw retained restorations or overdentures. Microdent Ektos Implant System is intended for immediate placement and function on single tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Small diameter implants are indicated only for replacement of central incisors in the maxilla and mandible.
| Type of Use (Select one or both, as applicable) | <span> <span style="text-decoration: underline;">Prescription Use</span> (Part 21 CFR 801 Subpart D) <span style="margin-left: 20px;">Over-The-Counter Use (21 CFR 801 Subpart C)</span> </span> |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
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FORM FDA 3881 (8/14)
Page 1 of 1
PSC Publishing Bervices (301) 443-6740 EF
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Image /page/3/Picture/0 description: The image contains a logo for Microdent Implant System. The logo features the letters "MD" inside a circle with three curved lines extending to the right, resembling sound waves. Below the circle, the word "MICRODENT" is written in a bold, sans-serif font, with the words "IMPLANT SYSTEM" in a smaller font size underneath.
# 510(k) SUMMARY (21 CFR 807.92)
This 510(k) summary is submitted in accordance with the requirement of 21 CFR 807.92
The assigned 510(k) number is:
### Premarket Notification [510(k)] Summary
### A. General Information
| Submitter's Name: | Implant Microdent Systems |
|-------------------|----------------------------------------------------------------------------------------------------|
| Address: | C/ Carles Buigas, 1 - Can Magre<br>Sta Eulalia de Ronçana<br>E-08187 Barcelona, Catalonia<br>Spain |
| Telephone: | +34-902-402-420 |
|-----------------|----------------------|
| Fax Number: | +34-94-844-7893 |
| Contact Person: | Jordi Clapes Donadeu |
| Date Prepared: | May 9th, 2016 |
- B. Device
| Trade Name: | Microdent Ektos Implant System |
|----------------------|----------------------------------------------------------|
| Classification Name: | Endosseous Dental Implants |
| Product Code: | DZE and NHA (DZE is considered the primary product code) |
| Class: | II |
| Regulation Number: | 21 CFR 872.3640 |
## C. Identification of Legally Marketed Predicate Device
Legacy System Dental Implants – K073033 (primary predicate) Microdent Genius Implant System – K141188 (reference predicate) Legacy Abutment System – K060063 (reference predicate)
## D. Description of the Device
Microdent Ektos Implant System is comprised of dental implants and prosthetic components. Microdent Ektos dental implants are internal connection endosseous implants machined in titanium that can be used with deferred load or immediate load techniques. The implant is designed to be inserted at crestal level. Microdent Ektos Implant is recommended to be placed at crestal bone level.
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Image /page/4/Picture/1 description: The image is a logo for Microdent Implant System. The logo features the letters "MD" inside of a circle, with a series of curved lines extending to the right of the circle. Below the circle, the word "MICRODENT" is written in a bold, sans-serif font, and below that, the words "IMPLANT SYSTEM" are written in a smaller, sans-serif font.
The implant has an internal hexagonal connection.
Microdent Ektos Implants are provided with blasted surface.
The implants are supplied sterile and the abutments are provided non-sterile.
- Implants are provided in the following diameters and length.
| Ø platform | Ø core | Length | Reference |
|------------|--------|--------|-----------|
| 3.50 | 3.70 | 8 | EK3708CP |
| | | 10 | EK3710CP |
| | | 12 | EK3712CP |
| | | 14 | EK3714CP |
| | | 16 | EK3716CP |
| | | 18 | EK3718CP |
| 3.50 | 4.20 | 8 | EK4208CP |
| | | 10 | EK4210CP |
| | | 12 | EK4212CP |
| | | 14 | EK4214CP |
| | | 16 | EK4216CP |
| | | 18 | EK4218CP |
| 4.50 | 4.80 | 8 | EK4808CP |
| | | 10 | EK4810CP |
| | | 12 | EK4812CP |
| | | 14 | EK4814CP |
| | | 16 | EK4816CP |
| | | 18 | EK4818CP |
| 5.70 | 5.80 | 8 | EK5808CP |
| | | 10 | EK5810CP |
| | | 12 | EK5812CP |
| | | 14 | EK5814CP |
| | | 16 | EK5816CP |
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Image /page/5/Picture/1 description: The image is a logo for Microdent Implant System. The logo features the letters "MD" inside of a circle, with three curved lines extending to the right of the circle. Below the circle, the word "MICRODENT" is written in a bold, sans-serif font, and below that, the words "IMPLANT SYSTEM" are written in a smaller, sans-serif font.
- . The system also contains Microdent Ektos abutments made of Ti-6AL 4-V-ELI alloy as follows:
The abutments Conical, Multi-function (supplied with the implant) and Mini Capitel are used for cemented and screw-retained restorations.
Conical abutment with flap as indicated in the following table:
| EKPCCP3501H | Microdent Ektos hex. Conical<br>with flap abutment | Plat. Ø 3.50<br>Height 1, 3 and 5 mm |
|--------------|--------------------------------------------------------|--------------------------------------|
| EKPCCP4501H | Microdent Ektos hex. Conical<br>with flap abutment | Plat. Ø 4.50<br>Height 1, 3 and 5 mm |
| EKPCCP5701H | Microdent Ektos hex. Conical<br>with flap abutment | Plat. Ø 5.70<br>Height 1 mm |
| EKPCCP3501R | Microdent Ektos Circular<br>Conical with flap abutment | Plat. Ø 3.50<br>Height 1, 3 and 5 mm |
| EKNPCCP4501R | Microdent Ektos Circular<br>Conical with flap abutment | Plat. Ø 4.50<br>Height 1, 3 and 5 mm |
| EKPCCP5701R | Microdent Ektos Circular<br>Conical with flap abutment | Plat. Ø 5.70<br>Height 1 mm |
Conical abutment without flap as indicated in the following table:
| EKPCSP3500H | Microdent Ektos Hex. Conical<br>without flap abutment | Plat. Ø 3.50<br>Height 0 to 5 mm |
|-------------|-----------------------------------------------------------|-----------------------------------|
| EKPCSP4500H | Microdent Ektos Hex. Conical<br>without flap abutment | Plat. Ø 4.50<br>Height 0 to 5 mm |
| EKPCSP5700H | Microdent Ektos Hex. Conical<br>without flap abutment | Plat. Ø 5.70<br>Height 0 and 1 mm |
| EKPCSP3500R | Microdent Ektos Circular<br>Conical without flap abutment | Plat. Ø 3.50<br>Height 0 to 5 mm |
| EKPCSP4500R | Microdent Ektos Circular<br>Conical without flap abutment | Plat. Ø 4.50<br>Height 0 to 5 mm |
| EKPCSP5700R | Microdent Ektos Circular<br>Conical without flap abutment | Plat. Ø 5.70<br>Height 0 and 1 mm |
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Image /page/6/Picture/1 description: The image contains a logo for Microdent Implant System. The logo features the letters "MD" inside a blue circle, with a series of curved lines emanating from the right side of the circle, resembling sound waves. Below the circle, the word "MICRODENT" is written in a bold, dark blue font, and below that, the words "IMPLANT SYSTEM" are written in a smaller, lighter blue font.
| EKPC13500H | Microdent Ektos hex. immediate<br>loading conical abutment | Plat. Ø 3.50<br>Height 0 mm |
|------------|-------------------------------------------------------------------|-----------------------------|
| EKPC4500H | Microdent Ektos hex. immediate<br>loading conical abutment | Plat. Ø 4.50<br>Height 0 mm |
| EKPC15700H | Microdent Ektos hex. immediate<br>loading conical abutment | Plat. Ø 5.70<br>Height 0 mm |
| EKPC13500R | Microdent Ektos Circular<br>immediate loading conical<br>abutment | Plat. Ø 3.50<br>Height 0 mm |
| EKPC4500R | Microdent Ektos Circular<br>immediate loading conical<br>abutment | Plat. Ø 4.50<br>Height 0 mm |
| EKPC15700R | Microdent Ektos Circular<br>immediate loading conical<br>abutment | Plat. Ø 5.70<br>Height 0 mm |
Immediate loading conical abutments as indicated in the following table:
Mini Capitel abutment as indicated in the following table:
| EKCAPN3501R | Microdent Ektos Circular Mini<br>Capitel Abutment | Plat. Ø 3.50<br>Height 1 to 4 mm |
|-------------|---------------------------------------------------|----------------------------------|
| EKCAPN4501R | Microdent Ektos Circular Mini<br>Capitel Abutment | Plat. Ø 4.50<br>Height 1 to 4 mm |
| EKCAPN5701R | Microdent Ektos Circular Mini<br>Capitel Abutment | Plat. Ø 5.70<br>Height 1 to 2 mm |
| UTSNPC4X | Microdent Ektos Mini Capitel<br>cementable coping | Ø 4.80 |
| UTSNPC51 | Microdent Ektos Mini Capitel<br>cementable coping | Ø 5.60 |
| UTSNCP4X | Microdent Ektos Mini Capitel<br>Protective Cap | Ø 4.80 |
| UTSNCP51 | Microdent Ektos Mini Capitel<br>Protective Cap | Ø 5.60 |
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Image /page/7/Picture/1 description: The image contains the logo for Microdent Implant System. The logo features the letters "MD" inside of a circle with three curved lines extending to the right of the circle. Below the circle, the word "MICRODENT" is written in a bold, dark blue font. Underneath "MICRODENT", the words "IMPLANT SYSTEM" are written in a smaller, less bold font.
- The following Cover Screws are provided to protect the inner configuration of the implant and are supplied sterile with the implant.
| EKTC35 | Microdent Ektos cover screw | Plat. Ø 3.50 |
|--------|-----------------------------|--------------|
| EKTC45 | Microdent Ektos cover screw | Plat. Ø 4.50 |
| EKTC57 | Microdent Ektos cover screw | Plat. Ø 5.70 |
- Healing abutment to shape the soft tissue during the healing phase as indicated in the following table:
| EKPR3502 | Microdent Ektos Healing<br>abutment | Ø 4.50<br>Height 2 to 5 mm |
|-----------|-------------------------------------|----------------------------|
| EKPR4502 | Microdent Ektos Healing<br>abutment | Ø 6.50<br>Height 2 mm |
| EKPR5702 | Microdent Ektos Healing<br>abutment | Ø 5.50<br>Height 1 to 6 mm |
| EKPCR3502 | Microdent Ektos Healing<br>abutment | Ø 3.50<br>Height 2 to 5 mm |
| EKPCR4502 | Microdent Ektos Healing<br>abutment | Ø 4.50<br>Height 2 to 5 mm |
| EKPCR5702 | Microdent Ektos Healing<br>abutment | Ø 5.70<br>Height 2 mm |
- The Retention Screws are used for securing the abutments to the implant.
- Overdenture retention consists of a titanium alloy socket that attached to a threaded post for use with titanium endosseous implants having an internal threaded socket. Both devices have a plastic component that has a shape on one and that mate into the titanium socket, while the other end with metal cap is attached to the denture.
| EKEOSS3500 | Microdent Ektos Osscilia<br>retention abutment | Ø 3.50<br>Height 0 to 4 mm |
|------------|------------------------------------------------|----------------------------|
| EKEOSS4500 | Microdent Ektos Osscilia<br>retention abutment | Ø 4.50<br>Height 0 to 4 mm |
| EKEOSS5700 | Microdent Ektos Osscilia | Ø 5.70 |
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Image /page/8/Picture/1 description: The image is a logo for Microdent Implant System. The logo features the letters "MD" inside of a circle, with three curved lines extending to the right of the circle. Below the circle, the word "MICRODENT" is written in a bold, sans-serif font. Below that, the words "IMPLANT SYSTEM" are written in a smaller, sans-serif font.
| | retention abutment | Height 0 to 1 mm |
|----------|-------------------------------|------------------|
| CSUTGOSS | Metal cap with soft, middle | Titanium grade 5 |
| | and strong Osscilia retainer. | +POM |
All abutments include appropriate features and dimensions to mate with Microdent Ektos implants. No compatibility with other implant systems is claimed.
#### E. Intended Use
Microdent Ektos Implant System is indicated for surgical placement in the upper or lower jaw arches, for single-stage or two-stage surgical procedures and cemented, screw retained restorations or overdentures. Microdent Ektos Implant System is intended for immediate placement and function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function.
Small diameter implants are indicated only for replacement of central and lateral incisors in the maxilla and mandible.
#### F. Summary of Testing and Comparison to the Predicate Device
The devices are designed and manufactured in accordance with the following standards:
ISO 5832-2:1999 Implants for surgery - Metallic materials - Part 2: Unalloyed titanium ISO 5832-3:1996 lmplants for surgery -- Metallic materials -- Part 3: Wrought titanium 6-aluminium 4-vanadium alloy
ISO 14971 Second edition 2007-03-01 Medical devices - Application of risk management to medical devices
ISO 14801 Second edition 2007-11-15 Dentistry-Implants-Dynamic fatigue test for endosseous dental implants
ISO 10993-1:2009 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity
USP 37t0 ed. 2014<85> Bacterial Endotoxins Test
USP 37th ed. 2014<151> Pyrogen Test
ISO 14698-1:2003 Cleanrooms and Associated Controlled Environments -Biocontamination Control - Part 1: General Principles and Methods
Cleanrooms and Associated Controlled Environments - Part 1: ISO 14644-1:1999 Classification of Air Cleanliness
ISO 14644-3:2005 Cleanrooms and associated controlled environments - Part 3: Test methods
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Image /page/9/Picture/1 description: The image is a logo for Microdent Implant System. The logo features the letters "MD" inside of a circle, with a series of curved lines emanating from the right side of the circle. Below the circle, the word "MICRODENT" is written in a bold, sans-serif font. Underneath "MICRODENT", the words "IMPLANT SYSTEM" are written in a smaller, sans-serif font.
ISO 11737-1:2006 (R)2011 Sterilization of medical devices - Microbiological methods Part 1: Determination of the population of microorganisms on product, 2ed
ISO 11737-2:2009 Sterilization of medical devices -- Microbiological methods --Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
ISO 11607-1:2006/(R)2010 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 11607-2:2006/(R)2010 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
ISO 11137-1:2006/(R) 2010 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices
ISO 11137-2:2012 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
ISO 11137-3:2006/(R)2010 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects.
ASTM F1980-07 (Reapproved 2011), Standard Guide For Accelerated Aging Of Sterile Barrier Systems For Medical Devices. (Sterility).
ANSI / AAMI ST79: 2010& A1:2010 & A2:2011 & A3:2012 & A4:2013 Comprehensive guide to steam sterilization and sterility assurance in health care facilities
### Comparison of Technological Characteristics
| Table 1: General Implant Device Comparison | | |
|--------------------------------------------|--|--|
|--------------------------------------------|--|--|
| Characteristic | Subject Device | Own predicate | Predicate Device | SE / Comments | Diameter (mm) | Diameter ranges:<br>3.7 mm, 4.2 mm,<br>4.8 mm, 5.8 mm<br>and 7.00 mm. | Diameter ranges:<br>3.5 mm, 4.5 mm,<br>5.0 and 5.5 mm. | Diameter ranges:<br>3.2 mm, 3.7 mm,<br>4.2 mm, 4.7 mm,<br>5.2 mm, 5.7 mm<br>and 7.0 mm. | Yes |
|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| Device | Microdent Ektos<br>implant | Microdent Genius<br>implant ( K141188) | Legacy System<br>Dental Implants<br>(K073033) | Yes (Microdent<br>Ektos and<br>Legacy have the<br>same hex<br>connection.<br>Microdent<br>Genius has<br>connection<br>tapered with<br>indexation, rest<br>of characteristics<br>same as<br>Microdent<br>Ektos) | Connection type | Internal connection with<br>hex. | Internal connection<br>with tapered<br>indexation. | Internal connection<br>with hex. | Yes with Legacy<br>(Hex<br>connection)<br>Different<br>connection from<br>Genius implant |
| Intended | Microdent Ektos Implant | Microdent Genius Implant | The intended use of the | Yes (Microdent | Surface treatment | Blasting<br>(roughness 0,82<br>μm<br>peak-to-valley). | same | SBM (Soluble Blast<br>Media) or<br>HA-coated. (SBM<br>roughness 1.5-2.3<br>μm peak-to-valley). | Yes (Blasted<br>treatment with<br>similar result) |
| | | | | | Sterilization | Sterile (Gamma<br>irradiation) | same | same | Yes |
| use | System is indicated for<br>surgical placement in the<br>upper or lower jaw arches,<br>for single-stage or two-stage<br>surgical procedures and<br>cemented, screw retained<br>restorations or<br>overdentures. Microdent<br>Ektos Implant System is<br>intended for immediate<br>placement and function on<br>single tooth and/or multiple<br>tooth applications when<br>good primary stability is<br>achieved, with appropriate<br>occlusal loading, in order to<br>restore chewing function.<br>Small diameter implants are<br>indicated only for<br>replacement of central and<br>lateral incisors in the<br>maxilla and mandible. | System is indicated for<br>surgical placement in the<br>upper or lower jaw arches, for<br>single-stage or two-stage<br>surgical procedures and<br>cemented, screw retained<br>restorations or overdentures.<br>Microdent Genius Implant<br>System is intended for<br>immediate placement and<br>function on single tooth and/or<br>multiple tooth applications<br>when good primary stability is<br>achieved, with appropriate<br>occlusal loading, in order to<br>restore chewing function.<br>Small diameter implants are<br>indicated only for replacement<br>of central and lateral incisors<br>in the maxillar and mandible. | Legacy System Implants with<br>HA Coating is identical to the<br>intended use of the predicate<br>abutments. These implants<br>are two-piece implants for<br>single-stage or two-stage<br>surgical procedures. The<br>Legacy implants are intended<br>for use in the mandible and<br>maxilla, in support of single or<br>multiple-unit cement or screw<br>receiving fixed restorations<br>and for retention and support<br>of overdentures. The implants<br>are intended for immediate<br>placement and function for<br>support of single tooth and/or<br>multiple tooth restorations,<br>recognizing bone stability and<br>appropriate occlusal load<br>requirements. | Ektos specified<br>the use of small<br>diameter implants,<br>Legacy System<br>are coated<br>blasted or HA<br>plasma) | Packaging | Inner sleeve to<br>suspend the<br>implant/fixture-m<br>ount assembly<br>packaged inside<br>an outer vial<br>sealed with a cap.<br>Packaging also<br>includes surgical<br>cover screw and<br>multi-function<br>abutment. | Packaged in sterile<br>vial with cover<br>screw | Inner sleeve to<br>suspend the<br>implant/fixture-mo<br>unt assembly<br>packaged inside<br>an outer vial sealed<br>with a cap.<br>Packaging also<br>includes surgical<br>cover screw,<br>extender and<br>temporary coping. | Yes (but Legacy<br>includes an<br>extender) |
| Indication | Delayed or<br>immediate load | same | same | Yes | Shelf Life | 5 years | same | same | Yes |
| Material | Comercially pure<br>titanium (grade<br>4 as ISO 5832-2) | same | Titanium Alloy<br>(grade 5 as ISO<br>5832-3) | Yes (Different<br>degree but with<br>very similar<br>properties) | Mating<br>Components | All Microdent<br>Restorative<br>Components | All Microdent<br>Restorative<br>Components | All Legacy<br>Restorative<br>Components | Yes |
| Design; | Threaded, root<br>form implant.<br>Image: Threaded, root form implant | same<br>Image: Threaded, root form implant | same<br>Image: Threaded, root form implant | Yes (Legacy<br>implant has<br>quadruple-lead<br>threads near top)<br>Image: Threaded, root form implant | | | | | |
| Length (mm) | 8, 10, 12, 14, 16<br>and 18 mm. | 8, 10, 12, 14, 16 and<br>18 mm. | 8, 10, 11.5, 13 and<br>16 mm | Yes | | | | | |
| Platform | Diameter ranges:<br>3.5 mm, 4.5 mm<br>and 5.7 mm. | Diameter ranges:<br>3.5 mm, 4.5 mm,<br>5.0 and 5.5 mm. | Diameter ranges:<br>3.0 mm, 3.5 mm,<br>4.5 mm and 5.7<br>mm | Yes | | | | | |
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Image /page/10/Picture/0 description: The image is a logo for Microdent Implant System. The logo features the letters "MD" inside of a circle with three curved lines extending to the right of the circle. Below the circle, the word "MICRODENT" is written in a bold, sans-serif font, and below that, the words "IMPLANT SYSTEM" are written in a smaller, sans-serif font.
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Image /page/11/Picture/0 description: The image is a logo for Microdent Implant System. The logo features the letters "MD" inside of a circle, with a series of curved lines extending to the right of the circle. Below the circle, the word "MICRODENT" is written in a bold, sans-serif font, and below that, the words "IMPLANT SYSTEM" are written in a smaller, sans-serif font.
# Table 2: General Prosthetic Device Comparison
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Image /page/12/Picture/0 description: The image is a logo for Microdent Implant System. The logo features the letters "MD" inside of a circle, with three curved lines extending to the right of the circle. The words "MICRODENT" and "IMPLANT SYSTEM" are written in a sans-serif font below the circle. The text and the circle are both blue.
| Characteristic | Subject Device | Own predicate | Predicate Device | SE / Comments |
|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| Device Name | Microdent Ektos<br>implant abutments | Microdent Genius<br>implant abutments | Legacy Abutment<br>System | yes |
| 510K | NA | K141188 | K060063 | Yes |
| Intended use | Microdent Ektos Implant System is indicated for surgical placement in the upper or lower jaw arches, for single-stage or two-stage surgical procedures and cemented, screw retained restorations or overdentures. Microdent Ektos Implant System is intended for immediate placement and function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Small diameter implants are indicated only for replacement of central and lateral incisors in the maxilla a nd mandible. | Microdent Genius Implant System is indicated for surgical placement in the upper or lower jaw arches, for single-stage or two-stage surgical procedures and cemented, screw retained restorations or overdentures. Microdent Genius Implant System is intended for immediate placement and function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Small diameter implants are indicated only for replacement of central and lateral incisors in the maxillar and mandible. | The Legacy Abutment System is intended for use with dental implants in the maxillary and/or mandibular arches to provide support for crowns, bridges, or overdentures for edentulous or partially edentulous patients. The Legacy Abutment System is compatible with implants that have mating diameters, lead-in bevels, internal hex sizes, and 1-72UNF internal threads, as shown in the Zimmer Dental Tapered Screw-Vent Surgical Manual. Implant Direct LLC will monitor the compatible implants for modifications to ensure future compatibility. In the event of any modification, Implant Direct LLC will either modify the Legacy abutment to ensure compatibility, or cease claiming compatibility to the modified Zimmer Dental Screw-Vent implants. | Yes (Ektos Microdent specified the use of small diameter implants.). |
| Material | Titanium alloy (Grade 5). | same | Titanium alloy. | Yes |
| Surface treatment | Polished. | same | same | Yes |
| Sterilization | Non-sterile | same | same | Yes |
| Packaging | Blister | same | same | Yes |
| Device Name | Microdent Ektos<br>cover screw | Microdent Genius<br>cover screw | Legacy cover screw | Yes |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| 510K | NA | K141188 | K073033 | Yes |
| Intended use | Microdent Ektos Implant<br>System is indicated for<br>surgical placement in the<br>upper or lower jaw arches, for<br>single-stage or two-stage<br>surgical procedures and<br>cemented, screw retained<br>restorations or overdentures.<br>Microdent Ektos Implant<br>System is intended for<br>immediate placement and<br>function on single tooth and/or<br>multiple tooth applications<br>when good primary stability is<br>achieved, with appropriate<br>occlusal loading, in order to<br>restore chewing function.<br>Small diameter implants are<br>indicated only for replacement<br>of central and lateral incisors<br>in the maxilla and mandible. | Microdent Genius Implant<br>System is indicated for<br>surgical placement in the<br>upper or lower jaw arches, for<br>single-stage or two-stage<br>surgical procedures and<br>cemented, screw retained<br>restorations or<br>overdentures. Microdent<br>Genius Implant System is<br>intended for immediate<br>placement and function on<br>single tooth and/or multiple<br>tooth applications when<br>good primary stability is<br>achieved, with appropriate<br>occlusal loading, in order to<br>restore chewing function.<br>Small diameter implants are<br>indicated only for<br>replacement of central and<br>lateral incisors in the<br>maxillar and mandible. | The intended use of the<br>Legacy System Implants with<br>HA Coating is identical to the<br>intended use of the predicate<br>abutments. These implants<br>are two-piece implants for<br>single-stage or two-stage<br>surgical procedures. The<br>Legacy implants are intended<b…
