Zuga Dental Implant System
Device Facts
| Record ID | K171197 |
|---|---|
| Device Name | Zuga Dental Implant System |
| Applicant | Zuga Medical, Inc. |
| Product Code | DZE · Dental |
| Decision Date | Jun 30, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3640 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Zuga™ Dental Implant System is indicated for immediate or delayed implant placement for surgical and restorative applications in maxillary and/or mandibular arches to support prosthetic devices, such as artificial teeth, crowns, bridges, and overdentures. The Zuga™ Dental Implant System is indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Device Story
Zuga Dental Implant System comprises endosseous dental implants, sealing/healing caps, abutments, and fixation screws. Implants are bone-level, self-tapping, root-form, threaded titanium. Components accommodate various patient anatomies for one- or two-stage surgical procedures. Implants are provided sterile; other components require sterilization by the clinician. Used by dentists/oral surgeons in clinical settings to restore chewing function. Output is a stable foundation for prosthetic devices. Benefits include restoration of dental function and aesthetics. Device is non-active, non-mechanical.
Clinical Evidence
Bench testing only. Static and dynamic fatigue testing performed per ISO 14801 and FDA guidance. Biocompatibility testing (cytotoxicity) performed per ISO 10993-5 and USP <87>. Sterility validated per ISO 11137 and ISO 17665. Bacterial endotoxin testing performed per USP <85> and <161> with acceptance criteria of <20 EU/device.
Technological Characteristics
Materials: Cold Worked Ti Grade 4 (ASTM F67), Ti-6Al-4V (ASTM F136), and Yttria-stabilized Zirconia. Design: Root-form, threaded, self-tapping endosseous implants. Surface: Al2O3 blasted and passivated. Sterilization: Gamma radiation (implants) or user-sterilized (abutments). Connectivity: Mechanical screw-retained abutment-to-implant interface (internal hex, external square).
Indications for Use
Indicated for patients requiring dental implants in maxillary or mandibular arches for support of prosthetic devices (artificial teeth, crowns, bridges, overdentures). Suitable for immediate or delayed placement and immediate loading if primary stability and appropriate occlusal loading are achieved.
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
- Zuga™ Dental Implant System (K122664)
- T-Plus Implant Tech. Co., Ltd. ST Internal Fixture System (K152787)
- OCO Biomedical Fixed Solid O-Ball Abutment (K090174)
- Nobel Biocare AB NobelActive Multi-Unit Abutment (K072570)
- Reliadent Dental Implant System (K043428, K061323)
- Biomet 3i Certain System (K0100724)
- KAT Implants System Implants, KAT Implants System Implant Abutment (K083544)
- KAT Implants System Implants, KAT Implants System Straight Abutments (K101201)
- Southern Implants Endosseous Dental Implant System (K070841, K071161)
Reference Devices
- Ex Feel Dental Implant System (K052369)
- Nova Implants Ltd. Ball Attachment BAT (K150363)
- SGS International Ltd. Overdenture Ball Attachment S3 (K133362)
- Biodenta Swiss AG Multi-Use Abutment (K123491)
- Biomet 3i Low Profile Abutment (K092341)
- 2014 InterActive/SwishActive System (K143011)
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left, and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 30, 2018
Zuga Medical, Inc. Chan Wang, CEO 24400 Chagrin Blvd. Suite 250 Beachwood, Ohio 44122
Re: K171197
Trade/Device Name: Zuga™ Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: May 25, 2018 Received: June 1, 2018
### Dear Chan Wang:
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 of medical device-related 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.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
# Andrew I. Steen -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
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### 7. Indications for Use Statement
510(k) Number: _K171197
Device Name: Zuga™ Dental Implant System
Indications for Use:
The Zuga™ Dental Implant System is indicated for immediate or delayed implant placement for surgical and restorative applications in maxillary and/or mandibular arches to support prosthetic devices, such as artificial teeth, crowns, bridges, and overdentures. The Zuga™ Dental Implant System is indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________ OR
(Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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## 510(k) Summary K171197
| Date: | 29 June 2018 |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Zuga Medical, Inc.<br>24400 Chagrin Boulevard<br>Suite 250<br>Beachwood, OH 44122<br>Phone: 216.282.5910<br>Facsimile: 1.855.438.9842 |
| Contact Person: | Chan Wang, CEO |
| Trade Names: | Zuga™ Dental Implant System |
| Device Classification: | Class II |
| Classification Name: | Implant, endosseous, root-form & abutment, implant, dental,<br>endosseous |
| Regulation: | 872.3640 |
| Device Product: | DZE & NHA |
| Device Description: | The Zuga™ Dental Implant System includes endosseous dental<br>implants, sealing caps, healing caps, dental implant abutments,<br>and fixation screws in a variety of sizes to accommodate differing<br>patient anatomy. Implantation is suitable for one-or two-stage<br>procedures.<br><br>Endosseous implants are bone level, self-tapping, root-form,<br>threaded. The threaded surface is blasted, then passivated.<br>Sizematched anterior and posterior abutments are offered. Thes<br>are fastened to the implant using a fixation screw. Sealing caps<br>and healing caps provide protection to the abutment connection<br>threads during endosseous and gingival healing.<br><br>The implants are provided sterile, the remaining components<br>must be sterilized prior to use. |
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| Implant | Material | Cold Worked Ti Grade 4 as described in ASTM F67 |
|-------------------------------|---------------------|------------------------------------------------------------------------------|
| | Diameter (mm) | 3.5, 4.3, 5.0 |
| | Length (mm) | 8.00, 9.00, 10.00, 11.00, 12.00,<br>13.00, 14.00, 15.00, 16.00, 17.00 |
| | Angulation | - |
| | Description | Endosseous Implant |
| Ti Abutment | Material | Cold Worked Ti Grade 4 as described in ASTM F67 |
| | Diameter (mm) | 4.75, 5.50, 6.25, 7.00 |
| | Post Height (mm) | 4.00, 5.50, 7.00 |
| | Angulation | - |
| | Description | Straight Titanium Abutment |
| Angled Abutment | Material | Cold Worked Ti Grade 4 as described in ASTM F67<br>or Cold Worked Ti Grade 5 |
| | Diameter (mm) | 3.5, 4.3, 5.0 |
| | Post Height (mm) | 8.50, 9.50, 10.50, 11.50 |
| | Angulation | 15, 25 |
| | Description | Angled Titanium Abutment |
| Ball Abutment | Material | Titanium CP Grade 4 Cold Worked or Annealed |
| | Diameter (mm) | 3.5 |
| | Gum Height (mm) | 1.00, 2.00, 3.00, 4.00, 5.00 |
| | Angulation | - |
| | Description | Abutment for overdenture restoration |
| Removable Denture<br>Abutment | Material | Titanium CP Grade 4 Cold Worked or Annealed |
| | Diameter (mm) | 3.85 |
| | Gum Height (mm) | 1.00, 2.00. 3.00, 4.00, 5.00 |
| | Angulation | - |
| | Description | Abutment for overdenture restoration |
| Hybrid Abutment | Material | ZIY and Cold Worked Ti Grade 4 as described in<br>ASTM F67 |
| | Diameter (mm) | 4.25, 4.30, 5.05, 5.50 |
| | Length (mm) | 10.50 |
| | Angulation | - |
| | Description | Titanium and Zirconium abutment |
| Multi-Unit Abutment | Material | Cold Worked Ti Grade 4 as described in ASTM F67 |
| | Diameter (mm) | 4.00, 4.80 |
| | Gum Height<br>(mm) | 1.50, 2.50, 3.50, 4.50 |
| | Angulation | 0, 17, 30 |
| | Description | Titanium Abutment to be used with multiple<br>prosthetic devices |
| Healing Cap | Material | Titanium CP Grade 4 Cold Worked or Annealed |
| | Diameter (mm) | 4.85, 5.65, 6.35 |
| | Post Height<br>(mm) | 3.00, 5.00, 7.00 |
| | Angulation | - |
| | Description | Protects implant during healing. |
| Fixation Screw | Material | Titanium 6AL-4V per ASTM F136 |
| | Diameter (mm) | 2.35 |
| | Length (mm) | 7.50 |
| | Angulation | - |
| | Description | Fastens abutment to implant |
| Sealing Cap | Material | Titanium CP Grade 4 Cold Worked or Annealed |
| | Diameter (mm) | 2.75 |
| | Length (mm) | 5.00 |
| | Angulation | - |
| | Description | Protects implant during healing. |
Zuga Medical is making no claims regarding pyrogenicity.
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| Indications for Use: | The Zuga™ Dental Implant System is indicated for immediate or<br>delayed implant placement for surgical and restorative<br>applications in maxillary and/or mandibular arches to support<br>prosthetic devices, such as artificial teeth, crowns, bridges and<br>overdentures. The Zuga™ Dental Implant System is indicated for<br>immediate loading when good primary stability is achieved and<br>with appropriate occlusal loading. |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate Devices: | Zuga™ Dental Implant System - K122664<br>T-Plus Implant Tech. Co., Ltd. ST Internal Fixture System –<br>K152787<br>OCO Biomedical Fixed Solid O-Ball Abutment – K090174<br>Nobel Biocare AB NobelActive Multi-Unit Abutment – K072570<br>Reliadent Dental Implant System - K043428, K061323<br>Biomet 3i Certain System – K0100724<br>KAT Implants System Implants, KAT Implants System Implant<br>Abutment – K083544<br>KAT Implants System Implants, KAT Implants System Straight<br>Abutments – K101201<br>Southern Implants Endosseous Dental Implant System –<br>K070841, K071161 |
| Technological<br>Characteristics: | The fundamental scientific technology of the Zuga™<br>Dental Implant System is the same as previously cleared devices<br>as shown below, (i.e. the Zuga design features are common to<br>one or more of the predicates). |
| Zuga Implant System | | | | | | |
|---------------------|----------------|--------------------------------|---------------------|-----------|---------------------|----------------------|
| | Subject Device | Primary<br>Predicate<br>Device | Reference Devices | | | |
| Company | Zuga Medical | Zuga Medical | Reliadent | Biomet 3i | KAT | Southern<br>Implants |
| 510(k) Number | New Device | K122664 | K043428,<br>K061323 | K100724 | K083544,<br>K101201 | K070841,<br>K071161 |
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| | | | | | KAT Implant<br>System<br>Dental<br>Implants are<br>indicated for<br>restoration of<br>edentulous<br>maxilla and<br>mandible, to<br>provide<br>support for<br>removable<br>dentures,<br>fixed bridges,<br>or to be used<br>as a single<br>tooth<br>replacement.<br>Single or<br>splinted<br>implants can<br>be<br>immediately<br>loaded if<br>good primary<br>stability and<br>appropriate<br>occlusal<br>loading are<br>achieved.<br>The implants<br>can be<br>placed in<br>extraction<br>sites or<br>healed<br>alveolar<br>ridges.<br>Immediate<br>loading may<br>not be<br>appropriate<br>in Type IV<br>bone due to<br>difficulty in<br>achieving<br>Primary<br>stability | The NSI<br>Implant<br>System is<br>intended to be<br>implanted in<br>the upper or<br>lower jaw<br>arches to<br>provide<br>support for<br>fixed or<br>removable<br>dental<br>prostheses in a<br>single tooth,<br>partially<br>edentulous<br>prostheses, or<br>full arch<br>prostheses. It<br>further adds<br>the option for<br>immediate<br>loading on<br>single and<br>splinted<br>multiple unit<br>restorations<br>when good<br>primary<br>stability is<br>achieved and<br>with<br>appropriate<br>occlusal<br>loading, to<br>restore<br>chewing<br>function. |
|--------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Zuga™<br>Dental Implant<br>System is<br>indicated for<br>immediate or<br>delayed implant<br>placement for<br>surgical and<br>restorative<br>applications in<br>maxillary and/or<br>mandibular<br>arches to<br>support<br>prosthetic<br>devices, such as<br>artificial teeth,<br>crowns, bridges,<br>and<br>overdentures.<br>The Zuga™<br>Dental Implant<br>System is<br>indicated for<br>immediate<br>loading when<br>good primary<br>stability is<br>achieved and<br>with appropriate<br>occlusal loading. | The Zuga™<br>Dental Implant<br>System is<br>indicated for<br>immediate or<br>delayed implant<br>placement for<br>surgical and<br>restorative<br>applications in<br>maxillary and/or<br>mandibular<br>arches to<br>support<br>prosthetic<br>devices, such as<br>artificial teeth,<br>crowns, bridges,<br>and<br>overdentures.<br>The Zuga™<br>Dental Implant<br>System is<br>indicated for<br>immediate<br>loading when<br>good primary<br>stability is<br>achieved and<br>with appropriate<br>occlusal loading. | The Reliadent<br>Dental Implant<br>System is<br>indicated for<br>immediate or<br>delayed surgical<br>and restorative<br>application for<br>placement in<br>maxillary and /or<br>mandibular<br>arches to<br>support<br>prosthetic<br>devices, such as<br>artificial teeth,<br>crowns, bridges<br>and<br>overdentures for<br>the patient. | BIOMET 3i<br>Dental<br>Implants are<br>intended for<br>surgical<br>placement in<br>either jaw and<br>used for<br>anchoring or<br>supporting<br>single- and<br>multiple-unit<br>prostheses.<br>BIOMET 3i<br>Dental<br>Implants can<br>be<br>immediately<br>loaded when<br>primary<br>stability and<br>proper<br>occlusion have<br>been<br>established. | | |
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| Material of<br>Manufacture: | Titanium,<br>Titanium Alloy | Titanium,<br>Titanium Alloy | Titanium | Titanium,<br>Titanium Alloy | Titanium<br>Alloy | Titanium |
|------------------------------|---------------------------------------|---------------------------------------|----------------------------------------|---------------------------------------|--------------------------------------------------------------------------|---------------------------------------|
| Endosseous Implant | | | | | | |
| Endosseous Implant<br>Design | Root-form,<br>Straight and<br>tapered | Root-form,<br>Straight | Root-form,<br>Straight | Root-form,<br>Straight and<br>tapered | Root-form,<br>Straight and<br>tapered | Root-form,<br>Straight and<br>tapered |
| Method of<br>stabilization | Threaded<br>fixation | Threaded<br>fixation | Threaded<br>fixation | Threaded<br>fixation | Threaded<br>fixation | Threaded<br>fixation |
| Range of Diameters | 3.5 – 5.5mm | 3.5 – 5.5mm | 3.0 – 5.5mm | 3.25 – 6mm | 2.5 – 8mm | ---- |
| Range of Lengths | 8 – 17 mm | 8 – 17 mm | 8 – 16mm | 8.5 – 20mm | 6 – 14mm | ---- |
| Surface Treatment | Al2O3 blasted,<br>passivated | Al2O3 blasted,<br>passivated | Titanium<br>blasted and<br>acid etched | acid etched | Al2O3<br>blasted,<br>passivated | Al2O3 blasted |
| Color-coding | Seating surface<br>or None | Seating surface | Anodized<br>seating | Seating<br>surface | None | None |
| Sterilization | Sterile,<br>Gamma<br>radiation | Sterile,<br>Gamma<br>radiation | Sterile,<br>Gamma<br>radiation | Sterile,<br>Gamma<br>radiation | Sterile,<br>Radiation | Sterile,<br>Gamma<br>radiation |
| Endosseous Implant Abutment | | | | | | |
| Abutment Design | Standard | Standard | Standard,<br>Angled | ---- | Standard,<br>Angled | Standard,<br>Angled |
| Sterilization | Non-sterile | Non-sterile | Non-sterile | ---- | Non-sterile | ---- |
| Connection to<br>Implant | Hex alignment,<br>screw<br>attachment | Hex alignment,<br>screw<br>attachment | Hex alignment,<br>screw<br>attachment | ---- | Indexing key<br>alignment,<br>1.5° locking<br>taper, screw<br>attachment | ---- |
| Color-coding | Connection<br>interface or none | Connection<br>interface | Connection<br>interface | ---- | ---- | ---- |
| Angled Abutment | | | |
|-----------------|----------------|------------------------------|------------------|
| | Subject Device | Primary Predicate<br>Devices | Reference Device |
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| System: | Zuga | T-Plus Implant Tech. Co., Ltd | MegaGen Co., Ltd |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Zuga Dental Implant System | ST Internal Fixture System | Ex Feel Dental Implant System |
| 510(k) Number | New Device | K152787 | K052369 |
| Intended Use | The Zuga™ Dental Implant System is indicated for immediate or delayed implant placement for surgical and restorative applications in maxillary and/or mandibular arches to support prosthetic devices, such as artificial teeth, crowns, bridges, and overdentures. The Zuga™ Dental Implant System is indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. | The ST Internal Fixture System is intended to be placed in the upper or lower jaw to support prosthetic devices, such as artificial teeth, and to restore a patient's chewing function. This may be accomplished using either a two stage surgical procedure or a single stage surgical procedure. The ST Internal Fixture System is intended for use for immediate loading when good primary stability is acheived and with appropriate occlusal loading. | The ExFeel Dental Implant Systems are intended to be placed in the upper or lower jaw to support prosthetic devices, such as artificial teeth, and to restore a patient's chewing function. This may be accomplished using either a two stage surgical procedure or a single state surgical procedure. |
| Abutment Diameters, mm | 3.5, 4.3, 5.0 | 4.0, 5.0, 6.0 | 4.0, 5.0, 6.0 |
| Abutment Cuff(Gum) Height, mm | 1.5, 2.5, 3.5, 4.5 | 1.0, 2.0, 3.0, 4.0, 5.0 | 2.0, 4.0 |
| Angulation Range | 15°, 25° | 15°, 25° | 15°, 25° |
| Implant to Abutment Connection | Internal Hexagon | Internal Hex Connection | Internal and External Hex |
| Abutment Fixation | Abutment Screw | - | - |
| Abutment Material | Titanium Alloy | C.P. Titanium and Titanium Alloy | C.P. Titanium and Titanium Alloy |
| Sterilization | Delivered Non-Sterile | Delivered Non-Sterile | Delivered Non-Sterile |
| Reusable | No | No | No |
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| Ball Abutment | | | | |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Subject Device | Primary Predicate Device | Reference Devices | |
| Company | Zuga Medical | OCO Biomedical | Nova Implants Ltd. | SGS International Ltd. |
| Device Name | Zuga Dental<br>Implant System -<br>Ball Abutment | Fixed Solid O-Ball<br>Abutment | Ball Attachment<br>BAT | Overdenture Ball Attachment S3 |
| 510(k) Number | New Device | K090174 | K150363 | K133362 |
| Intended Use | The Zuga™ Dental<br>Implant System is<br>indicated for<br>immediate or<br>delayed implant<br>placement for<br>surgical and<br>restorative<br>applications in<br>maxillary and/or<br>mandibular arches<br>to support<br>prosthetic<br>devices, such as<br>artificial teeth,<br>crowns, bridges,<br>and overdentures.<br>The Zuga™ Dental<br>Implant System is<br>indicated for<br>immediate<br>loading when<br>good primary<br>stability is<br>achieved and with<br>appropriate<br>occlusal loading. | The TSI and ERI<br>Dental Implants are<br>artificial root<br>structures<br>intended for<br>permanent surgical<br>implantation in<br>the bone for the<br>purpose of single or<br>multiple tooth<br>replacements<br>(splinted or free<br>standing), or for<br>stabilization of a<br>prosthetic system,<br>such as artificial<br>teeth in order to<br>restore the<br>patient's chewing<br>function. The TSI<br>and ERI can be<br>placed in the<br>anterior or<br>posterior<br>mandible/maxilla<br>for immediate or<br>delayed loading<br>purposes. | NOVA® Dental<br>Implants System is<br>indicated for<br>use in surgical and<br>restorative<br>applications for<br>placement in the<br>bone of the upper<br>or lower jaw to<br>provide support for<br>prosthetic<br>devices, such as<br>artificial teeth, in<br>order to restore the<br>patient's<br>chewing function.<br>NOVA® Dental<br>Implants System is<br>indicated also for<br>immediate<br>loading when<br>good primary<br>stability is<br>achieved and with<br>appropriate<br>occlusal loading. | SGS® Dental Implants System is<br>intended for surgical placement in the<br>maxillary and/or mandibular arch to<br>support crowns, bridges, or<br>overdentures in edentulous or<br>partially edentulous patients. SGS®<br>Dental Implants System may be<br>immediate loading when good<br>primary stability is achieved and with<br>appropriate occlusal loading. |
| Abutment Heights,<br>mm | 1, 2, 3, 4, 5 | 0, 2, 3, 4 | 1, 2, 3, 4, 5 ,6 | 1, 2, 3, 4, 5, 6 |
| Implant to<br>Abutment<br>Connection | External Square | External Square | Internal Hex | Internal Hex, Overdenture rest. |
| Abutment<br>Fixation | Screw Retained | Screw Retained | Screw Retained | - |
| Abutment Material | Titanium Alloy | Titanium Alloy | Titanium Alloy | Titanium Alloy |
| Sterilization | Delivered<br>NonSterile | - | - | - |
| Reusable | No | No | No | No |
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| Multi-Unit Abutment | | | | |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Subject…
