Implance Dental Implant System, Implance Dental Abutment System
Device Facts
| Record ID | K160221 |
|---|---|
| Device Name | Implance Dental Implant System, Implance Dental Abutment System |
| Applicant | Ags Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti. |
| Product Code | DZE · Dental |
| Decision Date | Sep 12, 2016 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3640 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
Implance Dental Implant System is indicated to use for surgical placement in the upper and lower jaw arches, to provide a root form means for single and multiple units' prosthetic appliance attachment to restore a patient's chewing function. Implance Dental Implant can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. Immediate loading is restricted to the anterior mandible based on four splinted-interforminal placed implants. Implance Dental Abutment System is used with a dental implant to prosthetic restorations such as crown, bridge and overdentures in partially or fully edentulous patients. Octa Abutment models that contain an abutment post height less than 4 mm are indicated only for multi-unit loading, such as bridge or overdenture.
Device Story
The Implance Dental Implant System consists of titanium alloy dental implants and closing screws, designed for surgical placement into the upper or lower jaw bone to support prosthetic restorations. Implants feature a sand-blasted resorbable blast media (RBM) surface. The system includes various bone-level and tissue-level implants with internal hexagonal or octagonal connections. The Implance Dental Abutment System provides the interface between the implant and the final prosthesis (crown, bridge, or overdenture). The device is used in a clinical setting by dental professionals. The implants are placed via conventional two-stage or single-stage surgical processes. The abutments are attached to the implants to support the superstructure, restoring the patient's chewing function. The system is intended to provide a stable foundation for prosthetic appliances, benefiting patients by replacing missing teeth and restoring oral function.
Clinical Evidence
Bench testing only. Biocompatibility testing (ISO 10993 series) confirmed material safety. Surface treatment analysis (SEM, EDX) confirmed homogeneity. Sterilization validation (gamma for implants, steam for abutments) achieved SAL 10^-6. Mechanical fatigue testing (ISO 14801) on worst-case configurations demonstrated performance consistent with FDA Class II Special Controls.
Technological Characteristics
Materials: Titanium Grade 4 (ASTM F-67) and Titanium Grade 5 (ASTM F-136). Design: Threaded root-form implants (bone/tissue level) with internal hexagonal/octagonal connections. Surface: RBM treated. Sterilization: Gamma (implants), steam (abutments). Connectivity: Mechanical interface between implant, abutment, and prosthesis.
Indications for Use
Indicated for partially or fully edentulous patients requiring dental implants and abutments for prosthetic restoration (crowns, bridges, overdentures) in the upper or lower jaw. Immediate loading is restricted to the anterior mandible using four splinted-interforminal implants. Octa abutments <4mm height are restricted to multi-unit loading.
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
Submission Summary (Full Text)
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around a central emblem. The emblem consists of a stylized representation of three human profiles facing to the right, stacked one behind the other, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 12, 2016
AGS Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti. % H. Semih Oktay, Ph.D. President CardioMed Device Consultants, LLC 5523 Research Park Drive, Suite 205 Baltimore, Maryland 21228
Re: K160221
Trade/Device Name: Implance Dental Implant System, Implance Dental Abutment System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: August 9, 2016 Received: August 10, 2016
Dear H. Semih Oktay:
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.
{1}------------------------------------------------
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 (OS) 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,
# Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
#### 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) K160221
R10021
Device Name Implance Dental Implant System Implance Dental Abutment System
### Indications for Use (Describe)
Implance Dental Implant System is indicated to use for surgical placement in the upper and lower jaw arches, to provide a root form means for single and multiple units' prosthetic appliance attachment to restore a patient's chewing function.
Implance Dental Implant can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading.
Immediate loading is restricted to the anterior mandible based on four splinted-interforminal placed implants.
Implance Dental Abutment System is used with a dental implant to prosthetic restorations such as crown, bridge and overdentures in partially or fully edentulous patients. Octa Abutment models that contain an abutment post height less than 4 mm are indicated only for multi-unit loading, such as bridge or overdenture.
Type of Use (Select one or both, as applicable)
> Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
### CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
### 510(K) SUMMARY
### I. SUBMITTER
AGS Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti. Mehmet Afkan Sok. No: 57 Kat: 1, 34718 Kosuyolu-Kadikoy Istanbul, TURKEY Phone: 00902165460078 Fax: 00902165460079
US Consultant: Semih Oktay 5523 Research Park Drive, Suite 205 Baltimore, MD 21228 Phone: (410) 674-2060 Email: soktay@cardiomedllc.com
Date of Summary
September 7, 2016
### II. DEVICE
| Proprietary name | Implance Dental Implant System<br>Implance Dental Abutment System |
|---------------------|-------------------------------------------------------------------|
| Common name | Endosseous Dental Implant & Abutments |
| Classification name | 21 CFR 872.3640 Endosseous Dental implant |
| Regulatory Class | II |
| Product Codes | DZE (Primary Product Code), NHA |
### III. PREDICATE DEVICE
| Primary Predicate Device: | Dentis Dental Device - K073486 |
|---------------------------|--------------------------------------------|
| Predicate Device: | Klockner Dental implant abutment - K122988 |
{4}------------------------------------------------
### IV DEVICE DESCRIPTION
The Implance Dental Implant System consists of titanium alloy dental implants and titanium closing screws. The Implance Dental Implants are intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore the patient's chewing function. The surface of the implant is sand-blasted with a resorbable blast media (RBM). The provided closing screw covers the Implance Dental Implant during the healing process.
The Implance Dental Implants (Table 1) are either bone level or tissue level type implants and are available in multiple designs. Bone Level Implants primarily contact bone, whereas the Tissue Level implant contacts bone and tissue along the cuff portion of the dental implant.
| Feature | Bone Level | Tissue Level |
|----------------|-------------------------|---------------------|
| Connection | Platform | Platform |
| Connection | Internal | Internal |
| Connection | Hexagonal | Octagonal |
| Diameters (mm) | 3.3; 3.7; 4.3; 4.8; 5.5 | 3.7; 4.3; 4.8 ; 5.5 |
| Length (mm) | 8, 10, 12, 14 | 8, 10, 12, 14 |
Table 1 Implance Dental Implant System Specifications
The Implance Dental Abutment System (Table 2), consisting of titanium temporary and final abutments and screws, provides the link between the Implance Dental Implant and the prosthesis that forms the superstructure and allows chewing. Final, permanent abutments are available in multiple designs and range in diameter from 2.9 mm to 6.5 mm; cuff heights of 0.5 mm to 5 mm and lengths of 7 mm to 16.4 mm.
{5}------------------------------------------------
# Table 2 Implance Dental Abutment Types
| GENERAL SPECIALTIES | | |
|----------------------------------|-------------------------------------------------|--------------------------------|
| Name | Type | Patient specific customization |
| COUPLE ABUTMENT | Cement-retained<br>Final-type<br>Screw Required | Yes |
| ANGLED ABUTMENT<br>BONE LEVEL | Cement-retained<br>Final-type<br>Screw Required | No |
| SOLID ABUTMENT | Cement-retained<br>Final-type | No |
| O-RING ABUTMENT | attachment-retained Final-type | No |
| MULTI ABUTMENT | Cement-retained<br>Final-type<br>Screw Required | Yes |
| OCTA ABUTMENT | Attachment and<br>Screw-retained<br>Final-type | No |
| SYNOCTA ABUTMENT<br>TISSUE LEVEL | Cement-retained<br>Final-type<br>Screw Required | Yes |
| HEALING ABUTMENT | temporary | No |
{6}------------------------------------------------
# Table 3 Implance Dental Abutment Sizes
| Tissue level / Bone level | Platform Diameter (mm) | Cuff height (mm) | Length (mm) | Implant connection | Raw material |
|---------------------------------------------------------|------------------------|------------------|-------------|---------------------------|--------------|
| Bone Level (for Ø 3.3mm implants) | 3.70 | 2.50 | 7.00 | conic internal connection | Ti Gr 5 |
| Bone Level (for Ø 3.3mm implants) | 3.70 | 3.50 | 8.00 | | |
| Bone Level (for Ø 3.3mm implants) | 3.70 | 5.00 | 9.50 | | |
| Bone Level (for Ø 3.3mm implants) | 3.70 | 7.00 | 11.50 | | |
| Bone level (for Ø 3.7,<br>4.3, 4.8, 5.5 mm<br>implants) | 4.5 - 5.5 -6.5 | 1.00 | 9.50 | conic internal connection | Ti Gr 5 |
| | | 2.00 | 10.50 | | |
| | | 3.00 | 11.50 | | |
| | | 4.00 | 12.50 | | |
| | | 5.00 | 13.50 | | |
| Tissue level (for Ø<br>3.7, 4.3, 4.8mm<br>implants) | 5.20 | 3.00 | 7.40 | conic internal connection | Ti Gr 4 |
| | 5.20 | 4.00 | 8.40 | | |
| | 5.20 | 5.50 | 9.90 | | |
| Tissue level (for Ø<br>5.5mm implants) | 6.40 | 3.00 | 7.40 | conic internal connection | Ti Gr 4 |
| | 6.40 | 4.00 | 8.40 | | |
| | 6.40 | 5.50 | 9.90 | | |
| Bone Level (for<br>3.3mm implants) | 3.70 | 1.00 | 11.50 | conic internal connection | Ti Gr 5 |
| | 3.70 | 2.00 | 12.50 | | |
| | 3.70 | 3.00 | 13.50 | | |
| | 3.70 | 4.00 | 14.50 | | |
| | 3.70 | 5.00 | 15.50 | | |
| Bone Level (for Ø<br>3.7, 4.3, 4.8, 5.5 mm<br>implants) | 4.5 - 5.5 -6.5 | 1.00 | 12.40 | conic internal connection | Ti Gr 5 |
| | | 2.00 | 13.40 | | |
| | | 3.00 | 14.40 | | |
| | | 4.00 | 15.40 | | |
| | | 5.00 | 16.40 | | |
| Tissue level (for Ø<br>3.7, 4.3, 4.8mm<br>implants) | 3.50 | -- | 9.00 | conic internal connection | Ti Gr 4 |
| | 3.50 | -- | 10.50 | | |
| | 3.50 | -- | 12.00 | | |
| Tissue level (for Ø<br>5.5mm implants) | 4.30 | -- | 9.00 | conic internal connection | Ti Gr 4 |
| | 4.30 | -- | 10.50 | | |
| | 4.30 | -- | 12.00 | | |
{7}------------------------------------------------
| COUPLE ABUTMENTS | Bone Level (for Ø 3.3mm implants) | | | | | | 3.70 | 1.00 | 8.50 | conic hexagonal<br>internal connection<br>(Ø 2.1mm hex) | Ti Gr 5 |
|------------------|--------------------------------------------------------------|--|-----------------|--|------|------|-------|-------|------------------------------------------------------------|---------------------------------------------------------|---------|
| | | | | | | | 3.70 | 2.00 | 9.50 | | |
| | | | | | | | 3.70 | 3.00 | 10.50 | | |
| | | | | | | | 3.70 | 4.00 | 11.50 | | |
| | | | | | | | 3.70 | 5.00 | 12.50 | | |
| | Bone level (for Ø 3.7, 4.3, 4.8, 5.5 mm implants) | | 4.5 - 5.5 - 6.5 | | | | 1.00 | 8.90 | conic hexagonal<br>internal connection<br>(Ø 2.495mm hex) | Ti Gr 5 | |
| | | | | | | | 2.00 | 9.90 | | | |
| | | | | | | | 3.00 | 10.90 | | | |
| | Bone level Non Hex<br>(for Ø 3.3mm implants) | | | | | 4.00 | 11.90 | | | | |
| | | | | | | 5.00 | 12.90 | | | | |
| | | | | | | 3.70 | 1.00 | 8.50 | conic non-hexagonal<br>internal connection | Ti Gr 5 | |
| | | | | | | 3.70 | 2.00 | 9.50 | | | |
| | | | | | | 3.70 | 3.00 | 10.50 | | | |
| | | | | | 3.70 | 4.00 | 11.50 | | | | |
| | | | | | 3.70 | 5.00 | 12.50 | | | | |
| | Bone level Non Hex<br>(for Ø 3.7, 4.3, 4.8, 5.5 mm implants) | | 4.5 - 5.5 - 6.5 | | | | 1.00 | 8.70 | conic non-hexagonal<br>internal connection | Ti Gr 5 | |
| | | | | | | | 2.00 | 9.70 | | | |
| | | | | | | | 3.00 | 10.70 | | | |
| | | | | | | | 4.00 | 11.70 | | | |
| | | | | | | | 5.00 | 12.70 | | | |
| | Tissue level (for Ø 3.7, 4.3, 4.8mm implants) | | | | | 5.20 | 1.00 | 8.75 | conic octagonal<br>internal connection<br>(Ø 3.095mm octa) | Ti Gr 4 | |
| | | | | | | 5.20 | 2.00 | 9.75 | | | |
| | | | | | | 5.20 | 3.00 | 10.75 | | | |
| | | | | | | 5.20 | 4.00 | 11.75 | | | |
| | Tissue level (for Ø 5.5mm implants) | | | | | 6.40 | 1.00 | 8.75 | conic octagonal<br>internal connection<br>(Ø 3.095mm octa) | Ti Gr 4 | |
| | | | | | | 6.40 | 2.00 | 9.75 | | | |
| | | | | | | 6.40 | 3.00 | 10.75 | | | |
| | | | | | | 6.40 | 4.00 | 11.75 | | | |
| | Tissue level non-octa<br>(for Ø 3.7, 4.3, 4.8mm implants) | | | | | 5.20 | 1.00 | 8.75 | non-octagonal<br>internal connection | Ti Gr 4 | |
| | | | | | | 5.20 | 2.00 | 9.75 | | | |
| | | | | | | 5.20 | 3.00 | 10.75 | | | |
| | | | | | | 5.20 | 4.00 | 11.75 | | | |
| | Tissue level non-octa<br>(for Ø 5.5mm implants) | | | | | 6.40 | 1.00 | 8.75 | non-octagonal<br>internal connection | Ti Gr 4 | |
| | | | | | | 6.40 | 2.00 | 9.75 | | | |
| | | | | | | 6.40 | 3.00 | 10.75 | | | |
| | | | | | | 6.40 | 4.00 | 11.75 | | | |
{8}------------------------------------------------
| MULTI ABUTMENTS | Bone level (for Ø 3.3mm implants) | 3.70 | 1.00 | 14.50 | conic hexagonal internal connection (Ø 2.1mm hex) | Ti Gr 5 |
|------------------|------------------------------------------------------------|----------------------|----------------------|-------------------------|------------------------------------------------------|---------|
| | Bone level (for Ø 3.7, 4.3, 4.8, 5.5 mm implants) | 4.50 | 1.00 | 15.63 | conic hexagonal internal connection (Ø 2.495mm hex) | Ti Gr 5 |
| | | 5.50 | 1.00 | 15.63 | | |
| | Bone level- Non hex (for Ø 3.3mm implants) | 3.70 | 1.00 | 14.50 | conic non-hexagonal internal connection | Ti Gr 5 |
| | Bone level- Non hex (for Ø 3.7, 4.3, 4.8, 5.5 mm implants) | 4.50 | 1.00 | 15.63 | conic non-hexagonal internal connection | Ti Gr 5 |
| | | 5.50 | 1.00 | 15.63 | | |
| | Tissue level | 5.20 -- | | 13.50 | conic octagonal internal connection (Ø 3.095mm octa) | Ti Gr 4 |
| | Tissue level-Non octa | 5.20 -- | | 13.50 | conic non-octagonal internal connection | Ti Gr 4 |
| OCTA ABUTMENTS | Bone level (for Ø 3.3mm implants) | 4.80 | 1.00 | 8.65 | conic hex internal connection (Ø 2.1mm hex) | Ti Gr 5 |
| | | 4.80 | 2.00 | 9.65 | | |
| | | 4.80 | 3.00 | 10.65 | | |
| | | 4.80 | 4.00 | 11.65 | | |
| | | 4.80 | 5.00 | 12.65 | | |
| | Bone level (for Ø 3.7, 4.3, 4.8, 5.5 mm implants) | 4.80 | 1.00 | 9.10 | conic hex internal connection (Ø 2.495mm hex) | Ti Gr 5 |
| | | 4.80 | 2.00 | 10.10 | | |
| | | 4.80 | 3.00 | 11.10 | | |
| | | 4.80 | 4.00 | 12.10 | | |
| | | 4.80 | 5.00 | 13.10 | | |
| | Tissue level | 3.50 -- | | 7.00 | conic octa internal connection (Ø 3.095mm octa) | Ti Gr 4 |
| SYNOCТА ABUTMENT | Tissue level | 3.50 -- | | 8.80 | conic octagonal internal connection (Ø 3.095mm octa) | Ti Gr 4 |
| | Tissue level-Non octa | 3.50 -- | | 8.80 | conic non-octagonal internal connection | Ti Gr 4 |
| O-RING ABUTMENTS | Bone level (for Ø<br>3.3mm implants) | 2.90<br>3.70<br>3.70 | 0.50<br>2.00<br>4.00 | 9.50<br>11.10<br>13.10 | conic internal<br>connection | Ti Gr 5 |
| | Bone level (for Ø 3.7,<br>4.3, 4.8, 5.5 mm<br>implants) | 3.42<br>4.50<br>4.50 | 0.50<br>2.00<br>4.00 | 10.10<br>11.60<br>13.60 | conic internal<br>connection | Ti Gr 5 |
| | Tissue level | 3.50<br>3.50<br>3.50 | 0.50<br>2.00<br>4.00 | 9.10<br>11.10<br>13.10 | conic internal<br>connection | Ti Gr 4 |
{9}------------------------------------------------
| | Bone level | Platform<br>Diameter<br>(mm) | Cuff<br>height<br>(mm) | Length<br>(mm) | Angle | Implant connection | Raw<br>material |
|--|-----------------------------------------------------------------|------------------------------|------------------------|----------------|-------|-----------------------------------------------------------|-----------------|
| | Bone level (for Ø<br>3.3mm implants) | 3.70 | 1.00 | 8.50 | 15° | conic hexagonal<br>internal connection<br>(Ø 2.1mm hex) | Ti Gr 5 |
| | | 3.70 | 2.00 | 9.50 | 15° | | |
| | | 3.70 | 4.00 | 11.50 | 15° | | |
| | | 4.50 | 2.00 | 10.59 | 15° | | |
| | | 4.50 | 2.00 | 10.95 | 25° | | |
| | | 4.50 | 4.00 | 12.59 | 15° | | |
| | | 4.50 | 4.00 | 12.95 | 25° | | |
| | Bone level (for Ø 3.7,<br>4.3, 4.8, 5.5 mm<br>implants) | 5.50 | 2.00 | 10.58 | 15° | conic hexagonal<br>internal connection<br>(Ø 2.495mm hex) | Ti Gr 5 |
| | | 5.50 | 2.00 | 11.06 | 25° | | |
| | | 5.50 | 4.00 | 12.58 | 15° | | |
| | | 5.50 | 4.00 | 13.06 | 25° | | |
| | | 6.50 | 2.00 | 10.57 | 15° | | |
| | | 6.50 | 2.00 | 11.13 | 25° | | |
| | | 6.50 | 4.00 | 12.57 | 15° | | |
| | | 6.50 | 4.00 | 13.13 | 25° | | |
| | Bone level Non Hex<br>(for Ø 3.3mm<br>implants) | 3.70 | 1.00 | 8.50 | 15° | conic non-hexagonal<br>internal connection | Ti Gr 5 |
| | | 3.70 | 2.00 | 9.50 | 15° | | |
| | | 3.70 | 4.00 | 11.50 | 15° | | |
| | Bone level Non Hex<br>(for Ø 3.7, 4.3, 4.8,<br>5.5 mm implants) | 4.50 | 2.00 | 10.38 | 15° | | Ti Gr 5 |
| | | 4.50 | 2.00 | 10.75 | 25° | | |
| | | 4.50 | 4.00 | 12.38 | 15° | | |
| | | 4.50 | 4.00 | 12.75 | 25° | | |
| | | 5.50 | 2.00 | 10.38 | 15° | conic non-hexagonal<br>internal connection | |
| | | 5.50 | 2.00 | 10.86 | 25° | | |
| | | 5.50 | 4.00 | 12.38 | 15° | | |
| | | 5.50 | 4.00 | 12.86 | 25° | | |
| | | 6.50 | 2.00 | 10.37 | 15° | | |
| | | 6.50 | 2.00 | 10.93 | 25° | | |
| | | 6.50 | 4.00 | 12.37 | 15° | | |
| | | 6.50 | 4.00 | 12.93 | 25° | | |
{10}------------------------------------------------
### V. INDICATIONS FOR USE
Implance Dental Implant System is indicated to use for surgical placement in the upper and lower jaw arches, to provide a root form means for single and multiple units' prosthetic appliance attachment to restore a patient's chewing function.
Implance Dental Implant can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading.
Immediate loading is restricted to the anterior mandible based on four splinted-interforminal placed implants.
Implance Dental Abutment System is used with a dental implant to provide support to prosthetic restorations such as crown, bridge and overdentures in partially or fully edentulous patients. Octa Abutment models that contain an abutment post height less than 4 mm are indicated only for multi-unit loading, such as a bridge or overdenture.
{11}------------------------------------------------
### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Technological characteristics of the Implance Dental Implant and Implance Dental Abutment Systems are compared with the predicate devices in the following tables.
| Table 4 Implance Dental Implant System Substantial Equivalence Comparison | | |
|---------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Implance Dental Implant System | Primary Predicate<br>Dentis Dental Implants System |
| 510k # | K160221 | K073486 |
| Indication | Indicated to use for surgical placement in<br>the upper and lower jaw arches, to provide<br>a root form means for single and multiple<br>units' prosthetic appliance attachment to<br>restore a patient's chewing function.<br>Implance can be placed with a<br>conventional two stage surgical process<br>with an option for transmucosal healing or<br>they can be placed in a single stage<br>surgical process for immediate loading.<br>Immediate loading is restricted to the<br>anterior mandible based on four splintel<br>interforminal placed implants. | Indicated for use for surgical placement in<br>the upper and lower jaw arches to provide a<br>root form means for single or multiple units<br>prosthetic appliance attachment to restore a<br>patients chewing function. Implants can be<br>placed with a conventional two stage<br>surgical process with an option for trans<br>mucosal Healing or they can be placed in a<br>single stage surgical process for immediate<br>loading. Immediate loading is restricted to<br>the anterior mandible based on four splintel<br>interforminal placed implants and not<br>indicated for single unsplinted implants. |
| System<br>Components | Dental implant and closing screw | Implant Fixtures, Protective Cap, and<br>Implant System Surgery Tray |
| Design | Threaded root-form bone or tissue level<br>implant with hybrid and straight designs<br>and Morse taper internal hexagon or<br>internal octagonal abutment interface | Threaded, root-form implant design with<br>Morse taper internal, external and<br>submerged abutment interface |
| Implant Size<br>(mm) | Length<br>8, 10, 12, 14 | Diameter<br>3.3, 3.7, 4.3,<br>4.8, 5.5 |
| | Length<br>7-14 | Diameter<br>3.5, 3.7, 4.1, 4.3,<br>4.8, 5.5, 6.0 |
| Materials | Titanium grade 4 & 5 | Titanium and its alloys |
| Surface<br>treatment | RBM surface treatment | RBM surface treatment |
| Sterilization | Gamma | Gamma |
| Standard for<br>Titanium | ASTM F-67 &<br>ASTM F-136-13 | ASTM F-67<br>ASTM F-136 |
| | Table 4 Implance Dental Implant System Substantial Equivalence Comparison | | |
|--|---------------------------------------------------------------------------|--|--|
| | | | |
구
{12}------------------------------------------------
| Table 5 Implance Dental Abutment System Substantial Equivalence Comparison | | |
|----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Implance Dental Abutment System | Klockner Dental implant abutment |
| 510(k) # | K160221 | K122988 |
| Indication | Implance Dental Abutment System is used<br>with a dental implant to provide support to<br>prosthetic restorations such as crown, bridge<br>and overdentures in partially or fully<br>edentulous patients. Octa Abutment models<br>that contain an abutment post height less<br>than 4 mm are indicated only for multi-unit<br>loading, such as a bridge or overdenture. | Klockner Dental Abutments are<br>intended to be placed into dental<br>implants to provide support for<br>prosthetic reconstructions such as<br>crowns, bridges or overdentures. The<br>Klockner Dental Implant Abutments<br>include healing caps, protective caps,<br>temporary abutments, angled<br>abutments, straight abutments, and<br>overdentures. All abutments are<br>intended to be used with the Klockner<br>Dental Implant Systems, Models:<br>Essential EC, Essential ES, Essential<br>ECK, Essential EC 1.5, SK2<br>and NK2. |
| Material | Titanium Grade 5 (Bone Level 3,3 & 3.7 mm<br>implants)<br>Titanium Grade 4 ASTM F-67 (Bone Level<br>4,3; 4,8; 5,5 mm implants)<br>Titanium Grade 4 ASTM F-67 (Tissue Level)<br>Screw: Titanium Grade 5 ASTM F136 | Titanium cp<br>Titanium alloy<br>Titanium cp +PMMA<br>Titanium Alloy + POM C |
| Design | Temporary Abutment design with attached<br>conic internal connection<br>Final Abutment designs:<br>Solid with cemented connection<br>Couple, Bone Level Angled (15°, 25°), Multi<br>and Synocta with cement and screw (conic,<br>conic hexagonal, or conic octagonal)<br>connection Octa with attached internal &<br>external (conic hexagonal or octagonal)<br>connection<br>O-ring with attached conic internal<br>connection | Temporary Abutment design<br>With internal octagonal connection<br>Final Abutment designs:<br>Angled (17°, 22°, 30°) with internal<br>octagonal and external hexagonal<br>screw connection<br>Straight with internal octagonal<br>screw connection<br>Overdenture abutment with ball<br>connection |
| Sterilization | Provided non-sterile | Provided non-sterile |
Table 5 Implance Dental Abutment System Substantial Equivalence Comparison
The Implance Dental Implant System is the same or similar to the primary predicate Dentis Dental Implant System with respect to indication for use, design, material composition and surface treatment. The proposed devices have more limited indications for use than the primary predicate that does not alter the intended use for demonstration of substantial equivalence. With respect to available sizes, the Implance Dental Implant System includes a slightly smaller diameter than the predicate. The slight reduction in diameter size does not change the intended anatomical location, and the non-clinical mechanical testing provided demonstrates substantially equivalent performance.
{13}------------------------------------------------
The Implance Dental Abutment System is the same or similar with respect to indication for use, material composition and basic design features as the predicate Klockner Dental Implant Abutments. The Implance Dental Abutment System differs from the predicate with additional abutment designs.
Non-clinical performance testing consistent with the FDA's Class II Special Controls guidance document and ISO 14801 support the substantial equivalence of the Implance Dental Implant System and the Implance Dental Abutment System.
## VII. PERFORMANCE DATA
Performance testing of the Implance Dental Implance Dental Abutment followed the FDA guidance Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments.
### Biocompatibility
- Cytotoxicity (in vitro) ISO 10993-5:2009 ●
- Sensitization- ISO 10993-10:2010 ●
- . Irritation/ Intracutaneous - ISO 10993-10:2010
- Acute systemic toxicity- ISO 10993-11:2006 ●
- . Subchronic toxicity- ISO 10993-11:2006
- Genotoxicity- ISO 10993-3:2003 ●
- Implantation- ISO 10993-6:2007 .
Biocompatibility testing found the materials used in the Implance Dental Implant & Implance Dental Abutment Systems are biocompatible.
### Surface Treatment Analysis
The Implance Dental Implant surface undergoes a RBM treatment using calcium phosphate micro particles. SEM analysis of the RBM surface found that the surface of the Implance Dental Implant was homogeneous. Energy-dispersive X-ray spectroscopy provided elemental analysis and chemical characterization of the RBM surface after washing.
### Sterilization Validation
Implance Dental Implants are sterilized using a gamma ray sterilization process that has been validated to ensure a SAL of 10°. The Implance Dental Abutment System is provided non-sterile. Sterilization of the dental abutment system is performed by the end-user following parameters used in a validated steam gravity sterilization method that achieves a SAL of 106. The Implance Dental Implants provided sterile propose a 5-year shelf life date. The following tests were performed to show the packaging was sufficient to maintain
{14}------------------------------------------------
sterility of the dental implants over the 5-year shelf life: Adhesion Strength Control Force (Seal Strength), Package Tightness (Seal Leak) Test, and Sterility Test.
### Mechanical Testing
Fatigue testing on the worst case bone level Implance Dental Implant with the worst case Implance Dental Abutment was conducted in accordance with the ISO 14801 Dentistry-Implants-Dynamic fatigue test for Endosseous dental implants. Results of the fatigue testing found that the worst case (bone level) dental implant/abutment combinations were consistent with FDA Class II Special Controls guidance and ISO 14801.
# VIII. CONCLUSION
The Implance Dental Implance Dental Abutment System have the same or similar intended use, material composition, basic design, dimensions and surface treatment. Based on an a comparative assessment with the predicate devices, and the performance test data, the Implance Dental Implance Dental Abutment Systems are determined to be substantially equivalent to the predicate devices.
