(263 days)
GPS® Angled Abutments are designed to be used in support of a dental implant(s) to provide support for prosthetic restorations in a partially or completely edentulous patient. These abutments are designed to only receive a fabricated multi-unit bridge or overdenture. Abutments are intended for use in the mandible or maxilla. Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.
GPS® Angled Abutments are designed to be used in conjunction with dental implant(s) to provide support for prosthetic restorations in a partially or completely edentulous patient. Abutments are intended for use in the mandible or maxilla. Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading. The proposed GPS® Angled Abutments are intended to provide extra prosthetic options currently unavailable to the clinician. The proposed abutments are intended to complement the cleared systems listed in Table 2 below. The proposed abutments have the same compatible implant interface specific to each implant system and platform size. The GPS® Angled abutments have the same coronal GPS Angled Top for all proposed GPS® Angled abutments. The GPS top has a superior outer radius at its coronal region that is identical to the primary predicate GoDirect implants (K090234 - Spectra System Dental Implants 2008). The proposed GPS® Angled abutments are a two-piece design having an identical lower piece with same interface features and angles as the reference predicate InterActive screw receiving angled abutments with a ball top (K130572 - InterActive/SwishPlus2 Implant System).
The provided text describes the 510(k) summary for the GPS® Angled Abutments, detailing their substantial equivalence to predicate devices. Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a quantitative format for specific performance metrics (e.g., "Must pass X N of force"). Instead, it confirms that the device meets the "equivalent or higher load" than the primary predicate device when tested according to FDA and ISO standards. The general acceptance criteria are:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical equivalence (static compression and fatigue endurance) | Withstands an equivalent or higher load than the primary predicate device. Tested according to FDA "Class II Special Control Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Abutments" and ISO 14801. |
| Sterilization validation (steam sterilization) | Steam sterilization validated to a sterility assurance level (SAL) of 10-6 conforming to AAMI/ANSI/ISO 17665-1 and ANSVAAMI ST79. Compatible GPS comfort cap also validated. |
| Biocompatibility | Testing conducted according to ISO 10993-5. Results did not show a toxic reaction from the proposed finished devices. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: The document indicates that testing was performed on "the worst case abutment testing" (InterActive® /SwishActive GPS® Angled Abutment, 3.0 mm Platform) and "the proposed Angled GPS Abutments, primary predicate GoDirect implant and compatible comfort caps." However, it does not provide specific numerical sample sizes (e.g., how many abutments were tested for fatigue).
- Data Provenance: The studies are non-clinical performance data, likely conducted by Implant Direct Sybron Manufacturing, LLC which is located in Thousand Oaks, California, USA. The data is retrospective in the sense that it's generated for a regulatory submission rather than a prospective clinical trial. There's no mention of country of origin of data beyond the company's location.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This section is not applicable as the document describes non-clinical performance data (mechanical, sterilization, biocompatibility testing) rather than a study requiring expert-established ground truth like image analysis or disease diagnosis.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This section is not applicable for the same reason as point 3.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This section is not applicable. The document describes a medical device (dental abutment), not an AI diagnostic tool that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable for the same reason as point 5.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As mentioned in point 3, the studies are non-clinical performance evaluations. The "ground truth" for these tests are universally accepted scientific and engineering standards:
- Mechanical Testing: ISO 14801 standards for fatigue, and static compression tests. The ground truth is the physical failure or endurance limit of the material under applied forces.
- Sterilization: Sterility assurance level (SAL) of 10-6, as per AAMI/ANSI/ISO 17665-1 and ANSVAAMI ST79. The ground truth is the measurable absence of viable microorganisms.
- Biocompatibility: ISO 10993-5 standards for biological evaluation of medical devices. The ground truth is the measurable absence of toxic reaction from the devices.
8. The sample size for the training set
This section is not applicable. The device is a physical medical implant, not an algorithm that requires a training set.
9. How the ground truth for the training set was established
This section is not applicable for the same reason as point 8.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the symbol in a circular fashion. The logo is presented in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 26, 2016
Implant Direct Sybron Manufacturing, LLC Ms. Renee Bennett Regulatory Affairs Specialist 3050 East Hillcrest Drive Thousand Oaks, California 91362
Re: K153509
Trade/Device Name: GPS® Angled Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: July 27, 2016 Received: July 28, 2016
Dear Ms. Bennett:
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 (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,
Tina Kiang
-s
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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Indications for Use
510(k) Number (if known) K153509
Device Name GPS® Angled Abutments
Indications for Use (Describe)
GPS® Angled Abutments are designed to be used in support of a dental implant(s) to provide support for prosthetic restorations in a partially or completely edentulous patient. These abutments are designed to only receive a fabricated multi-unit bridge or overdenture. Abutments are intended for use in the mandible or maxilla. Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.
Compatibility:
· Legacy System: Prosthetically compatible with Zimmer Dental Tapered Screw-Vent system implants (3.7mmD, 4.1mmD, 8mm-16mm Length), 4.5mm platform implants(4.7mmD, 8mm-16mm Length), and 5.7mm platform implants (6.0mmD, 8mm-16mm Length).
•SwishTapered System: Prosthetically compatible with Straumann Standard Plus system RN platform implants (3.3mmD-4.8mmD, 6mm-16mm Length) and WN platform implants(4.8mmD, 6mm-12mm Length). •SwishPlus System: Prosthetically compatible with Straumann Standard Plus system RN platform implants (3.3mmD-4.8mmD, 6mm-16mm Length) and WN platform implants (4.8mmD, 6mm-12mm Length). •SwishActive Implants: SwishActive implants are prosthetically compatible with InterActive 3.0 and 3.4mm abutments and Nobel Biocare conical connection NobelActive™ NP (Narrow Platform - 3.0mm diameter) and NobelActive™ RP (Regular Platform - 3.4mm diameter) titanium abutments. InterActive 3.0 and 3.4mm abutments are prosthetically compatible with Nobel Biocare connection NobelActive™ NP (Narrow Platform-3.0mm diameter) and NobelActive™ RP (Regular Platform - 3.4mm diameter) (3.5-5.0mmD. 8.5-18mmLength). • InterActive System: InterActive implants are prosthetically compatible with InterActive 3.0 and 3.4mm abutments and Nobel Biocare conical connection NobelActive™ NP (Narrow Platform - 3.0mm diameter) and NobelActive™ RP (Regular Platform - 3.4mm diameter) titanium abutments. InterActive 3.0 and 3.4mm abutments are prosthetically compatible with Nobel Biocare conical connection Nobel Active™ NP (Narrow Platform- 3.0mm diameter) and NobelActive™ RP (Regular Platform - 3.4mm diameter) (3.5-5.0mmD, 8.5-18mmLength) implants.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY for GPS® Angled Abutments
1. Submitter Information:
| Company: | Implant Direct Sybron Manufacturing LLC |
|---|---|
| Address: | 3050 East Hillcrest Drive, Thousand OaksCA 91362 USA |
| Contact Person:Telephone Number: | Renee Bennett818-444-3348 |
| Date Prepared: | August 16, 2016 |
| Device Name: | |
| ● Proprietary Name: | GPS® Angled Abutments |
| ● Classification Name: | Endosseous Dental Implant Abutment |
| ● CFR Number: | 872.3630 |
| ● Device Class: | II |
| ● Product Code: | NHA |
| Predicate Device: | Primary: GoDirect implants cleared underK090234 - Spectra System Dental Implants2008Reference: Straight GPS abutments clearedunder K130572 - InterActive/SwishPlus2Implant SystemReference: Screw Receiving abutment withBall top cleared under K143011- 2014InterActive / SwishActive System |
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Description of Device: 4.
GPS® Angled Abutments are designed to be used in conjunction with dental implant(s) to provide support for prosthetic restorations in a partially or completely edentulous patient. Abutments are intended for use in the mandible or maxilla. Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.
The proposed GPS® Angled Abutments are intended to provide extra prosthetic options currently unavailable to the clinician. The proposed abutments are intended to complement the cleared systems listed in Table 2 below. The proposed abutments have the same compatible implant interface specific to each implant system and platform size.
| # | System Name | 510(k) | ProposedCompatible GPS®Abutments |
|---|---|---|---|
| 1 | InterActive SwishPlus2Implant System | K130572 | InterActive®SwishActive GPSAngled Abutments |
| 2 | Legacy Abutment System | K060063 | Legacy GPS® AngledAbutments |
| 3 | Spectra System(RePlant) | K061319 | Replant GPS® AngledAbutments |
| 4 | Swissplant Dental ImplantSystem | K081396 | Swish GPS® AngledAbutments |
TABLE 1: List of cleared Implant Direct systems and the proposed compatible GPS® angled abutments
From Table 1, the worst case GPS® Angled abutment is the InterActive® /SwishActive GPS® Angled Abutment, 3.0 mm Platform. The 3.0 mm platform assembly represents the smallest size abutment from the InterActive system. Since the 3.4 mm implant and screw size is larger, the abutments are stronger than the 3.0 mm platform abutments. Hence, the 3.0 mm platform represents the worst case.
New fatigue testing has been completed on the worst case proposed GPS® Angled Abutment assembly..
The GPS® Angled abutments have the same coronal GPS Angled Top for all proposed GPS® Angled abutments. The GPS top has a superior outer radius at its coronal region that is identical to the primary predicate GoDirect implants (K090234 - Spectra System Dental Implants 2008). Since the proposed GPS® Angled abutments have the same coronal top design as the primary predicate GoDirect implants (K090234 - Spectra System Dental Implants 2008), the same compatibility will be achieved with the Zest
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Locator® liner type attachments manufactured by Zest Anchor, Inc.
-
- Indications for Use:
GPS® Angled Abutments are designed to be used in support of a dental implant(s) to provide support for prosthetic restorations in a partially or completely edentulous patient. These abutments are designed to only receive a fabricated multi-unit bridge or overdenture. Abutments are intended for use in the mandible or maxilla. Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.
- Indications for Use:
Compatibility:
·Legacy System: Prosthetically compatible with Zimmer Dental Tapered Screw-Vent system 3.5mm platform implants (3.7mmD, 4.1mmD, 8mm-16mm Length), 4.5mm platform implants(4.7mmD, 8mm-16mm Length), and 5.7mm platform implants (6.0mmD, 8mm-16mm Length).
·SwishTapered System: Prosthetically compatible with Straumann Standard and Standard Plus system RN platform implants (3.3mmD-4.8mmD, 6mm-16mm Length) and WN platform implants(4.8mmD, 6mm-12mm Length).
·SwishPlus System: Prosthetically compatible with Straumann Standard and Standard Plus system RN platform implants (3.3mmD-4.8mmD, 6mm-16mm Length) and WN platform implants (4.8mmD, 6mm-12mm Length).
·SwishActive Implants: SwishActive implants are prosthetically compatible with InterActive 3.0 and 3.4mm abutments and Nobel Biocare conical connection NobelActive™ NP (Narrow Platform - 3.0mm diameter) and NobelActive™ RP (Regular Platform - 3.4mm diameter) titanium abutments. InterActive 3.0 and 3.4mm abutments are prosthetically compatible with Nobel Biocare conical connection NobelActive™ NP (Narrow Platform- 3.0mm diameter) and NobelActive™ RP (Regular Platform - 3.4mm diameter) (3.5-5.0mmD. 8.5-18mmLength).
·InterActive System: InterActive implants are prosthetically compatible with InterActive 3.0 and 3.4mm abutments and Nobel Biocare conical connection NobelActive™ NP (Narrow Platform - 3.0mm diameter) and NobelActive™ RP (Regular Platform - 3.4mm diameter) titanium abutments. InterActive 3.0 and 3.4mm abutments are prosthetically compatible with Nobel Biocare conical connection NobelActive™ NP (Narrow Platform- 3.0mm diameter) and NobelActive™ RP (Regular Platform - 3.4mm diameter) (3.5-5.0mmD, 8.5-18mmLength) implants.
-
- Description of Safety and Substantial Equivalence:
Technological Characteristics
The proposed Implant Direct Sybron Manufacturing LLC GPS® Angled abutments have the same intended use and technological characteristics and hence are shown to be substantially equivalent to the primary predicate device GoDirect implants (cleared under K090234 - Spectra System Dental Implants 2008). The proposed GPS Angled abutments and primary predicate GoDirect implants
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(K090234) system contains both implants and abutments, and the intended use reflects this. The difference in the indications for use of the proposed devices and the primary predicate was due to the GoDirect implant being cleared with other Implant Direct implants (K090234), as part of the Spectra-System Dental Implants 2008. Also, the primary predicate was originally cleared with implants that are intended for both single unit and multi-unit restorations, while the proposed devices are only indicated for multi-unit bridge or overdentures and not for single unit restorations. Thus, 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.
In addition, the reference predicate GPS Straight Abutments (cleared under K143011- 2014 InterActive / SwishActive System) and the reference predicate InterActive® Screw Receiving Overdenture abutment with a ball top (cleared under K130572 - InterActive/SwishPlus2 Implant System) are also considered substantially equivalent. The worst case proposed angled GPS abutment uses the same compatible implant interfaces, have the same thread size, same materials, same coatings, and same manufacturing processes as reference predicate abutments (K143011 - 2014 InterActive / SwishActive System).
The proposed GPS Angled abutments have the same coronal top features as the primary predicate GoDirect Implant (K090234 - Spectra System Dental Implants 2008) and reference predicate GPS Straight Abutments (cleared under K143011 -2014 InterActive / SwishActive System). The proposed GPS® Angled abutments are a two-piece design having an identical lower piece with same interface features and angles as the reference predicate InterActive screw receiving angled abutments with a ball top (K130572 - InterActive/SwishPlus2 Implant System).
The proposed GPS® Angled Abutments differ from the primary predicate by having a two piece design with an angled body that utilizes a GPS top piece in order to have the same GPS compatibility with removable attachments.
These changes do not affect substantial equivalence of the proposed devices as demonstrated by internal performance and biocompatibility testing. GPS® Angled Abutment are substantially equivalent to the primary predicate GoDirect device cleared under (K090234 - Spectra System Dental Implants 2008) based on composition, performance and testing comparisons.
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| TechnologicalCharacteristics | ProposedDevice: GPS®AngledAbutment | Primary PredicateDevice:GoDirect Implants(K090234 – SpectraSystem DentalImplants 2008) | Reference PredicateDevice: StraightGPS Abutment(K143011 - 2014InterActive/SwishActiveSystem) | ReferencePredicate Device:InterActive®Swishplus2Implant System(Abutment withBall Top)(K130572 -InterActive/SwishPlus2Implant System) |
|---|---|---|---|---|
| Manufacturer | Implant DirectLLC | Implant Direct LLC | Implant Direct LLC | Implant Direct LLC |
| Regulation No. | 21 CFR 872. 3630 | 21 CFR 872. 3640 | 21 CFR 872. 3640 | 21 CFR 872. 3640 |
| RegulationClass | II | II | II | II |
| Product Code | NHA | DZE, NHA | DZE, NHA | DZE, NHA |
| TechnologicalCharacteristics | ProposedDevice: GPS®AngledAbutment | Primary PredicateDevice:GoDirect Implants(K090234 - SpectraSystem DentalImplants 2008) | Reference PredicateDevice: StraightGPS Abutment(K143011 - 2014InterActive/SwishActiveSystem) | ReferencePredicate Device:InterActive®Swishplus2Implant System(Abutment withBall Top)(K130572 –InterActive/SwishPlus2Implant System) |
| Indicationsfor Use | GPS® AngledAbutments aredesigned to beused in support | Spectra-SystemDental implants 2008are comprised of dentalimplant fixtures andprosthetic devices thatcompose a two- pieceimplant system. Theimplants are intendedfor the use in themandible and maxilla,in support of single unitor multiple unit cementor screw receivingrestorations and forretention and supportofoverdentures.The implants areintended for immediateplacement and functionfor the support ofsingle tooth ormultiple-toothrestorations,recognizing bonestability andappropriate occlusalload requirements. | InterActive®/SwishActiveImplant Systemconsists of two-piece implants forone-stage or two-stage surgicalprocedures. Theseimplants areintended for use inpartially and fullyedentulous upperand lower jaws insupport of single ormultiple-unitrestorations andterminal orintermediateabutment supportfor fixedbridgework.Implants can beindicated forimmediate loadingwhen good primarystability has beenachieved and withappropriateocclusal loading. | InterActive®/SwishPlus2Implant Systemconsists of two-piece implants forone-stage or two-stage surgicalprocedures. Theseimplants areintended for use inpartially and fullyedentulous upperand lower jaws insupport of single ormultiple-unitrestorations andterminal orintermediateabutment supportfor fixed |
TABLE 2: Substantial Equivalence: Comparison of Proposed Device with Predicate on Technological Characteristics
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| Compatibility: |
|---|
| •Legacy System:Prostheticallycompatible withZimmer DentalTapered Screw-Ventsystem 3.5mmplatform implants(3.7mmD, 4.1mmD,8mm-16mmLength), 4.5mmplatformimplants(4.7mmD,8mm-16mmLength), and 5.7mmplatform implants(6.0mmD, 8mm-16mm Length).•SwishTaperedSystem:Prostheticallycompatible withStraumann Standardand Standard Plussystem RN platformimplants (3.3mmD-4.8mmD, 6mm-16mm Length) andWN platformimplants(4.8mmD,6mm-12mmLength).•SwishPlus System:Prostheticallycompatible withStraumann Standardand Standard Plussystem RN platformimplants (3.3mmD-4.8mmD, 6mm-16mm Length) andWN platformimplants (4.8mmD,6mm-12mmLength). |
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| TechnologicalCharacteristics | ProposedDevice: GPS®AngledAbutment | Primary PredicateDevice:GoDirect Implants(K090234 – SpectraSystem DentalImplants 2008) | Reference PredicateDevice: StraightGPS Abutment(K143011 – 2014InterActive/SwishActiveSystem) | ReferencePredicate Device:InterActive®Swishplus2Implant System(Abutment withBall Top)(K130572 –InterActive/SwishPlus2Implant System) |
|---|---|---|---|---|
| SwishActive Implants:SwishActive implants are prosthetically compatible with InterActive 3.0 and 3.4mm abutments and Nobel Biocare conical connection NobelActiveTM NP (Narrow Platform – 3.0mm diameter) and NobelActiveTM RP (Regular Platform – 3.4mm diameter) titanium abutments. InterActive 3.0 and 3.4mm abutments are prosthetically compatible with Nobel Biocare conical connection NobelActiveTM NP (Narrow Platform– 3.0mm diameter) and NobelActiveTM RP (Regular Platform – 3.4mm diameter) (3.5–5.0mmD, 8.5-18mmLength). |
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| InterActive System:InterActiveimplants areprostheticallycompatible withInterActive 3.0and 3.4mmabutments andNobel Biocareconical connectionNobelActive™ NP(Narrow Platform– 3.0mmdiameter) andNobelActive™ RP(Regular Platform– 3.4mmdiameter)titaniumabutments.InterActive 3.0and 3.4mmabutments areprostheticallycompatible withNobel Biocareconical connectionNobelActive™ NP(Narrow Platform–3.0mm diameter)and NobelActive™RP (RegularPlatform – 3.4mmdiameter) (3.5-5.0mmD, 8.5-18mmLength)implants. | ||
|---|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | -- | -- |
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| GeneralDesign | 2-piece abutmentwith a GPS top forcompatibility with asnap-on capattachment systemand a implantengaging featurewith 15 degree and30 degree angledbase. | GPS top integrated intocoronal end of implantutilizing snap-on capattachment systems. | 1-piece abutment witha GPS top forcompatibility withsnap-on capattachment systemand with a threadedouter body to attach toimplant. | 2-piece abutment witha ball top forcompatibility with asnap-on capattachment systemand a implantengaging feature with15 degree and 30degree angled base. | |
|---|---|---|---|---|---|
| a) | FixationscrewDesign | Same | N/A | Different | Same |
| b) Lowerpiecedesign | Same | N/A | Different | Same | |
| c) | Coronaltop design(OuterFeatures) | Same | Same | Same | Different |
| TechnologicalCharacteristics | ProposedDevice: GPS®AngledAbutment | Primary PredicateDevice:GoDirect Implants(K090234 - SpectraSystem DentalImplants 2008) | Reference PredicateDevice: StraightGPS Abutment(K143011 - 2014InterActive/SwishActiveSystem) | ReferencePredicate Device:InterActive®Swishplus2Implant System(Abutment withBall Top)(K130572 -InterActive/SwishPlus2Implant System) | |
| d) Coronaltop design(InternalFeatures) | Same | Same | Different | Different | |
| e) AbutmentAngle | 15° and 30° | 0° | 0° | 15° and 30° | |
| f) Abutment /ImplantInterfaceType | Engaging | N/A | Non-engaging | Engaging | |
| g) Attachment-AbutmentInterfacePlatform | 3.9mm | 3.9mm | 3.9mm | 2.54mm | |
| Material | Titanium alloybase with TiNcoating | Titanium alloy basewith TiN coronalsurface | Titanium alloybase with TiNcoating | Titanium alloybase | |
| Sterilization: | Provided non-sterile withvalidated steamsterilizationinstructions foruse. Productlabel indicatessterilityaccording to ISOstandard. | Provided sterile. Nosterilizationinstructions needed forsterile product.Sterilization process isvalidated. Product labelindicates sterilityaccording to ISOstandard. | Provided non-sterile withvalidated steamsterilizationinstructions for use.Product labelindicates sterilityaccording to ISOstandard. | Provided non-sterile withvalidated steamsterilizationinstructions for use.Product labelindicates sterilityaccording to ISOstandard. | |
| Packaging | Mounted to innervial, inside anouter vial andsealed with a cap | Mounted to inner vial,inside an outer vial andsealed with a cap | Mounted to innervial, inside an outervial and sealedwith a cap | Mounted to innervial, inside an outervial and sealedwith a cap |
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Non-Clinical Performance Data
Non-clinical testing was performed on the proposed GPS® Angled abutments.
Mechanical testing was performed on the proposed devices following FDA "Class II Special Control Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Abutments" and ISO 14801 in static compression and fatigue. The worst case abutment testing was performed on the proposed abutments with Implant Direct implants and with compatible third party implants. The implant/abutment device combinations were able to withstand an equivalent or higher load than the primary predicate device.
In addition, validations were conducted on non-sterile abutments for steam sterilization and biocompatibility testing.
A steam sterilization validation was conducted using the same sterilization parameters specified in the instructions for use which is used for the proposed devices. A sterilization validation was conducted on a non-sterile abutment conforming to AAMI/ANSI/ISO 17665-1 and ANSVAAMI ST79 to a sterility assurance level (SAL) of 10 -6. In addition, the compatible GPS comfort cap was validated to be steam sterilizable.
Biocompatibility testing was conducted on the devices made with the same material and processes as the GPS components. Testing was conducted on the proposed Angled GPS Abutments, primary predicate GoDirect implant and compatible comfort caps according to ISO 10993-5. The results did not show a toxic reaction from the proposed finished devices.
The non-clinical performance data demonstrates that the proposed GPS® Angled abutments are mechanically equivalent, can be steam sterilized, and are biocompatible for the intended use.
Clinical Performance Data [N/A]
Clinical data is not needed to adequately characterize substantial equivalence.
Conclusion as to Substantial Equivalence
The differences between the proposed devices and the predicate device were reviewed to evaluate the substantial equivalency. The following features are modifications to the primary predicate device.
- · The proposed Angled GPS abutments are a multiple piece design using an angled abutment, fixation screw, and a GPS top to make the complete assembly. In comparison, the primary predicate GoDirect implant (K090234 - Spectra System Dental Implants 2008) is a solid
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device where the coronal end of the implant is machined with GPS features. The coronal end of the GoDirect implant has the same features (including coating) as the GPS top (P/N: 1000-90S).
- The proposed Angled GPS abutments are manufactured at angles of 15° and 30°. The primary predicate device GPS top is straight and aligned with the implant axis.
The technical characteristics and non - c l i n i c a 1 performance data demonstrate that the proposed GPS® Angled Abutments are substantially equivalent to the primary predicate device (GoDirect implant cleared under K090234 - Spectra System Dental Implants 2008).
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)