(152 days)
Inclusive® Titanium Abutments are premanufactured prosthetic components connected to endosseous dental implants in the edentulous or partially edentulous maxilla or mandible to provide support for cement-retained prosthetic restorations.
All digitally designed abutments for use with Inclusive Abutments for CAD/CAM are intended to be sent to a Prismatik Dentalcraft validated milling center for manufacture.
Compatible Implant System: MegaGen AnyRidge® Implant System Implant Diameter (mm) 3.5, 4.0, 4.4, 4.9, 5.4, 5.9, 6.4, 6.9, 7.4, 7.9, 8.4 Platform Diameter (mm) 3.5 and 5.0
Inclusive® Titanium Abutments compatible with: MegaGen AnyRidge Implant System are made of titanium alloy and have a prefabricated, precision interface (implant/ abutment connection) and are to be used for fabrication of patient-specific custom abutments using CAD/CAM technology. Each patient-specific abutment is individually prescribed by the clinician and manufactured by a Prismatik Dentalcraft authorized milling center. The proposed device is compatible with the MegaGen AnyRidge Implant System (K140091); 3.5, 4.0. 4.4, 4.9, 5.4, 5.9, 6.4, 6.9, 7.4, 7.9, 8.4mm implant diameter. Abutments are made from alloyed titanium Ti-6Al-4V ELI which meets ASTM standard F-136.
The Titanium Abutment Blanks are used for fabrication of all-titanium patient-specific abutments. These abutments include Multi-unit, Esthetic, and Straight Abutments. The Straight Abutments come in both Engaging and Non-Engaging connections. The Straight abutments 4.5 mm and 6.0 mm are used for support of CAD/CAM fabricated crowns / bridges or CAD/CAM fabricated zirconia copings. A patient-specific finished device for the 4.5 mm and 6.0 mm straight abutments will consist of both the titanium base and zirconia coping and will contain no angle correction.
The provided text describes the submission of Inclusive® Titanium Abutments compatible with: MegaGen AnyRidge® Implant System for FDA 510(k) clearance, asserting substantial equivalence to predicate devices. The study conducted is primarily non-clinical performance testing.
Here's the breakdown of the requested information based on the provided document:
1. Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in a table format alongside specific reported device performance values. Instead, it states that "The technological characteristics of the subject device have been verified to be essentially the same as the predicate device based on assessments of material composition, dimensional features, and mechanical properties." and that "Comparative testing was performed to show equivalence to the predicate device. This testing was performed according to ISO 14801:2007." This implies that the acceptance criteria are met if the device's performance is comparable to, or within the established range of, the predicate devices under the specified ISO standard for dental implants.
The reported device performance is that it met the requirements of ISO 14801:2007 through Reliability Calculation, Fatigue Testing, and Static Load Failure Testing.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for the non-clinical tests (Reliability Calculation, Fatigue Testing, Static Load Failure Testing).
The data provenance is retrospective, as it relies on established standards and comparative testing against predicate devices. The document does not mention the country of origin of the data, but the testing was conducted to meet FDA guidance and ISO standards.
3. Number of Experts and their Qualifications for Ground Truth
This question is not applicable to this submission. The ground truth for this type of device (dental abutments) is established through objective, standardized mechanical and material testing as per ISO and FDA guidance, rather than expert consensus on interpretive data (e.g., medical images).
4. Adjudication Method for the Test Set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for human-reviewed data, typically in diagnostic studies. For mechanical performance testing, the results are objectively measured against established standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret patient cases, often with and without AI assistance, to measure improvements in diagnostic accuracy or efficiency. The device in question is a dental abutment, and its effectiveness is determined by mechanical and material properties, not human interpretation of cases.
6. Standalone Performance Study (Algorithm Only)
No. A standalone algorithm performance study was not done. This device is a physical medical device (dental abutment), not an AI algorithm. Its performance is assessed through laboratory testing, not algorithmic output without human involvement.
7. Type of Ground Truth Used
The ground truth used for this device is based on established engineering standards and regulatory guidance. Specifically:
- ISO 14801:2007: Standard for fatigue testing of endosseous dental implants.
- FDA Guidance: "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments".
- Material Standards: ASTM standard F-136 for Ti-6Al-4V ELI.
- Biocompatibility Testing: Applicable prior biocompatibility testing for reference devices K121406 and K143353 (Sensitization, Cytotoxicity, and Systemic Toxicity).
These standards define the acceptable mechanical properties, material composition, and biological safety for such devices.
8. Sample Size for the Training Set
This question is not applicable. The device is a physical medical device, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set was Established
This question is not applicable, as there is no training set for a physical dental abutment.
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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring three stylized human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 6, 2017
Prismatik Dentalcraft, Inc. Maria Wagner Sr. Specialist, Regulatory Affairs 2212 Dupont Dr., Suite P Irvine, California 92612
Re: K170044
Trade/Device Name: Inclusive® Titanium Abutments compatible with: MegaGen AnyRidge® Implant System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: May 8. 2017 Received: May 10, 2017
Dear Maria Wagner:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
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) K170044
Device Name
Inclusive® Titanium Abutments compatible with: MegaGen AnyRidge® Implant System
Indications for Use (Describe)
Inclusive® Titanium Abutments are premanufactured prosthetic components connected to endosseous dental implants in the edentulous or partially edentulous maxilla or mandible to provide support for cement-retained prosthetic restorations.
All digitally designed abutments for use with Inclusive Abutments for CAD/CAM are intended to be sent to a Prismatik Dentalcraft validated milling center for manufacture.
Compatible Implant System: MegaGen AnyRidge® Implant System Implant Diameter (mm) 3.5, 4.0, 4.4, 4.9, 5.4, 5.9, 6.4, 6.9, 7.4, 7.9, 8.4 Platform Diameter (mm) 3.5 and 5.0
| 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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Image /page/3/Picture/0 description: The image contains the logo for Prismatik Dentalcraft, Inc. On the left is a triangular prism with different colors. To the right of the prism is the company name in blue text.
007_510(k) Summary-807.92(c)
This 510(k) summary is being submitted in accordance with the requirements of SMDA of 1990 and 21 CFR 807.92.
A. SUBMITTER INFORMATION
B.
Panel:
| Company Name: | Prismatik Dentalcraft, Inc. |
|---|---|
| Company Address: | 2212 Dupont Dr., Suite P,Irvine, CA 92612 |
| Company Phone: | 949-440-2636 |
| Company FAX: | (978) 313-0850 |
| Facility Registration Number: | 2031503 |
| Primary Contact Person: | Maria E. Wagner, (949) 440-2636Senior Specialist, Regulatory Affairs |
| Secondary Contact Person | Shelly Harris, (949) 440-2631Director, RA/QA |
| Date Summary Prepared: | June 05, 2017 |
| DEVICE IDENTIFICATION | |
| Trade/Proprietary Name: | Inclusive® Titanium Abutments compatiblewith: MegaGen AnyRidge Implant System |
| 21 CFR Reference: | 21 CFR 872.3630 |
| 21 CFR Common Name: | Endosseous dental Implant Abutment |
| Classification: | Class II, NHA |
C. IDENTIFICATION OF PREDICATE DEVICE
| Primary Predicate: | Inclusive Abutments (K160979) |
|---|---|
| Reference Device: | Inclusive® Titanium Abutments forAstra OsseoSpeed Implants (K100993)XPEED AnyRidge Internal Implant System(K140091)Hahn Tapered Implant System (K143353)Inclusive Tapered Implant System(K121406)Shofu MonoCem Resin Cement (K020481) |
Dental
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Image /page/4/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a colorful triangle on the left and the company name on the right. The triangle is divided into several sections, each with a different color. The company name is written in blue, with "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the bottom line.
PROPOSED DEVICE DESCRIPTION D.
Inclusive® Titanium Abutments compatible with: MegaGen AnyRidge Implant System are made of titanium alloy and have a prefabricated, precision interface (implant/ abutment connection) and are to be used for fabrication of patientspecific custom abutments using CAD/CAM technology. Each patient-specific abutment is individually prescribed by the clinician and manufactured by a Prismatik Dentalcraft authorized milling center. The proposed device is compatible with the MegaGen AnyRidge Implant System (K140091); 3.5, 4.0. 4.4, 4.9, 5.4, 5.9, 6.4, 6.9, 7.4, 7.9, 8.4mm implant diameter. Abutments are made from alloyed titanium Ti-6Al-4V ELI which meets ASTM standard F-136.
The Titanium Abutment Blanks are used for fabrication of all-titanium patientspecific abutments. These abutments include Multi-unit, Esthetic, and Straight Abutments. The Straight Abutments come in both Engaging and Non-Engaging connections. The Straight abutments 4.5 mm and 6.0 mm are used for support of CAD/CAM fabricated crowns / bridges or CAD/CAM fabricated zirconia copings. A patient-specific finished device for the 4.5 mm and 6.0 mm straight abutments will consist of both the titanium base and zirconia coping and will contain no angle correction.
ட். INDICATIONS FOR USE
Inclusive® Titanium Abutments are premanufactured prosthetic components connected to endosseous dental implants in the edentulous or partially edentulous maxilla or mandible to provide support for cement-retained or screwretained prosthetic restorations.
All digitally designed abutments for use with Inclusive Abutments for CAD/CAM are intended to be sent to a Prismatik Dentalcraft validated milling center for manufacture.
Compatible Implant System: MegaGen AnvRidge® Implant System Implant Diameter (mm) 3.5, 4.0, 4.4, 4.9, 5.4, 5.9, 6.4, 6.9, 7.4, 7.9, 8.4 Platform Diameter (mm) 3.5, 5.0.
ட் DETERMINATION OF SUBSTANTIAL EQUIVALENCE
Inclusive® Titanium Abutments compatible with: MegaGen AnyRidge Implant System are substantially equivalent to the Titanium Abutments used in the MegaGen AnyRidge Implant System identified in Section C above. This includes the Multi-unit, Esthetic, Engaging and Non-Engaging Abutments. They are substantially equivalent in intended use, materials, design and performance. Provided below is Table 1 which provides a comparison between the predicate, referenced and proposed devices. Table 3 also provide additional referenced device with our CAD/CAM submission.
Inclusive® Titanium (Multi-unit, Esthetic, Engaging and Non-Engaging), Abutments are fabricated to be compatible with the predicate device connection.
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Image /page/5/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a colorful triangle on the left and the company name on the right. The triangle is divided into several sections, each with a different color. The company name is written in a sans-serif font.
They are substantially equivalent in intended use, materials, design and performance with the reference predicates as depicted in Table 2 and 2A below (2A is specific to 4.5 mm and 6.0mm).
The differences between the predicate and proposed devices have been evaluated per the testing described in section G (non-clinical testing) and the proposed device is substantially equivalent to the predicate (See Comparison Tables below).
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Image /page/6/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a colorful triangle on the left and the company name on the right. The triangle is divided into several sections, each with a different color. The company name is written in a sans-serif font.
Table 1 – Comparison between Predicate and Proposed Device
| Attributes | PrimaryPredicate | ReferenceDevice | ReferenceDevice | ReferenceDevice | ReferenceDevice | ProposedDevice | SimilaritiesandDifferences |
|---|---|---|---|---|---|---|---|
| InclusiveAbutments | XpeedAnyRidgeImplant System | InclusiveTitaniumAbutments forAstraTechOsseoSpeedImplants | Hahn TaperedImplant System | InclusiveTaperedImplant System | InclusiveTitaniumAbutmentscompatible with:MeqaGenAnyRidge ImplantSystem | N/A | |
| 510(k) number | K160979 | K140091 | K100993 | K143353 | K121406 | K170044 | N/A |
| Manufacturer: | PrismatikDentalcraft Inc. | MegagenImplant Co.,Ltd. | PrismatikDentalcraft, Inc. | PrismatikDentalcraft, Inc. | PrismatikDentalcraft, Inc. | PrismatikDentalcraft, Inc. | N/A |
| Indications for Use | InclusiveAbutments arepremanufacturedprostheticcomponentsconnected toendosseousdental implantsin theedentulous orpartiallyedentulousmaxilla ormandible toprovide supportfor cement-retained orscrew-retained | The XpeedAnyRidge®Internal ImplantSystem isintended to besurgicallyplaced in themaxillary ormandibularmolar areas forthe purposeprovidingprostheticsupport fordentalrestorations(Crown,bridges, and | InclusiveTitaniumAbutments forAstraOsseoSpeedImplants arepremanufacturedprostheticcomponentsdirectlyconnected toendosseousdental implantsand areintended for useas an aid inprostheticrehabilitation. | Hahn Implantsare indicated foruse in maxillaryand mandibularpartially or fullyedentulouscases, tosupport single,multiple-unit,andoverdenturerestorations.The implantsare to be usedfor immediateloading only inthe presence ofprimary stability | InclusiveTaperedImplant Systemis indicated foruse in maxillaryand mandibularpartially or fullyedentulouscases, tosupport single,multiple-unit,andoverdenturerestorations.The implantsare to be usedfor immediateloading only in | Inclusive®TitaniumAbutments arepremanufacturedprostheticcomponentsconnected toendosseousdental implantsin theedentulous orpartiallyedentulousmaxilla ormandible toprovide supportfor cement-retained or | Theindications foruse is thesame as ourprimarypredicate. Theonly differenceis the implantcompatibilityto the Ref.Device(K140091). |
| Attributes | PrimaryPredicate | ReferenceDevice | ReferenceDevice | ReferenceDevice | ReferenceDevice | ProposedDevice | SimilaritiesandDifferences |
| InclusiveAbutments | XpeedAnyRidgeImplant System | InclusiveTitaniumAbutments forAstraTechOsseoSpeedImplants | Hahn TaperedImplant System | InclusiveTaperedImplant System | InclusiveTitaniumAbutmentscompatible with:MegaGenAnyRidge ImplantSystem | N/A | |
| 510(k) number | K160979 | K140091 | K100993 | K143353 | K121406 | K170044 | N/A |
| prostheticrestorations.All digitallydesignedabutments foruse withInclusive®Abutments forCAD/CAM areintended to besent to aPrismatikDentalcraftvalidated millingcenter formanufacture | overdentures)in partially orfully edentulousindividuals. It isused to restorea patient'schewingfunction.Smallerimplants (lessthan 6.0mm)are dedicatedfor immediateloading whengood primarystability isachieved andwith appropriateocclusalloading. Largerimplants arededicated forthe molar | They arecompatible withthe Astra TechOsseoSpeed3.0, 3.5, 4.0, 4.5,5.0 implants. | and appropriateocclusalloading. | the presence ofprimary stabilityand appropriateocclusalloading. | screw-retainedprostheticrestorations.All digitallydesignedabutments foruse withInclusiveAbutments forCAD/CAM areintended to besent to aPrismatikDentalcraftvalidated millingcenter formanufacture.CompatibleImplant System:MegaGenAnyRidge® | ||
| Attributes | PrimaryPredicate | ReferenceDevice | ReferenceDevice | ReferenceDevice | ReferenceDevice | ProposedDevice | SimilaritiesandDifferences |
| InclusiveAbutments | XpeedAnyRidgeImplant System | InclusiveTitaniumAbutments forAstraTechOsseoSpeedImplants | Hahn TaperedImplant System | InclusiveTaperedImplant System | InclusiveTitaniumAbutmentscompatible with:MegaGenAnyRidge ImplantSystem | N/A | |
| 510(k) number | K160979 | K140091 | K100993 | K143353 | K121406 | K170044 | N/A |
| PlatformCompatibility | 3.0-7.0mm | K140091region and areindicated fordelayedloading. | Implantdiameters: 3.0,3.5, 4.0, 4.5,5.0mm | 3.0, 3.5, 4.3,5.0 and7.0mm | 3.7, 4.7, and5.2mm | Implant Diameter(mm) 3.5, 4.0,4.4, 4.9, 5.4, 5.9,6.4, 6.9, 7.4, 7.9,8.4PlatformDiameter (mm)3.5 and 5.0ImplantDiameters: 3.5,4.0, 4.4, 4.9,5.4,5.9, 6.4, 6.9,7.4, 7.9,8.4mm | Same asreferencedevice |
| Connection | Hexagon | Hexagon | Hexagon | Hexagon | Hexagon | Hexagon | Same |
| Material | Ti-6Al-4V ELI | CP Ti Grade 4 | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Same aspredicate |
| Design/Construction | Machined | Machined | Machined | Machined | Machined | Machined | Same |
| Anatomical Site | Oral Cavity | Oral Cavity | Oral Cavity | Oral Cavity | Oral Cavity | Oral Cavity | Same |
| Implant Seat | Sits on a Taper | Sits on a Taper | Sits on a Taper | Sits on a Taper | Sits on a Taper | Sits on a Taper | Same |
| Screw Seat | Sits on a Flat | Sits on a Flat | Sits on a Flat | Sits on a Flat | Sits on a Flat | Sits on a Flat | Same |
| Attributes | PrimaryPredicate | ReferenceDevice | ReferenceDevice | ReferenceDevice | ReferenceDevice | ProposedDevice | SimilaritiesandDifferences |
| InclusiveAbutments | XpeedAnyRidgeImplant System | InclusiveTitaniumAbutments forAstraTechOsseoSpeedImplants | Hahn TaperedImplant System | InclusiveTaperedImplant System | InclusiveTitaniumAbutmentscompatible with:MegaGenAnyRidge ImplantSystem | N/A | |
| 510(k) number | K160979 | K140091 | K100993 | K143353 | K121406 | K170044 | N/A |
| Conclusion: | The comparison above outline the similarities between the predicate and proposed devices. Prismatik has presented comparativedata in the preceding paragraphs that demonstrate that Inclusive® Titanium Abutments are substantially equivalent to thepredicate device. Any differences between the proposed device and the predicate device do not introduce any new concerns ofsafety and effectiveness. |
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Image /page/7/Picture/0 description: The image contains the logo for Prismatik Dentalcraft, Inc. The logo consists of a colorful triangular prism on the left and the company name on the right. The prism is divided into sections with different colors, including pink, magenta, blue, and green. The company name is written in a sans-serif font, with "PRISMATIK" on the first line and "DENTALCRAFT, INC." on the second line.
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Image /page/8/Picture/0 description: The image contains the logo for Prismatik Dentalcraft, Inc. The logo consists of a colorful triangle on the left and the company name on the right. The triangle is divided into smaller triangles, each with a different color. The company name is written in a sans-serif font, with "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the bottom line.
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Image /page/9/Picture/0 description: The image contains the logo for Prismatik Dentalcraft, Inc. The logo consists of a colorful triangle on the left and the company name on the right. The triangle is divided into sections with different colors, including pink, red, yellow, green, and blue. The company name is written in a sans-serif font, with "PRISMATIK" on the first line and "DENTALCRAFT, INC." on the second line.
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Image /page/10/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. On the left is a triangle with different colors. The colors are arranged in a circular pattern, with blue at the bottom, green on the right, and pink at the top. To the right of the triangle is the text "PRISMATIK DENTALCRAFT, INC." The text is in a sans-serif font and is blue.
| Table 2 Comparison of variation of Abutments (Multi-Unit, Esthetic, Engaging and Non-Engaging) | |||||||
|---|---|---|---|---|---|---|---|
| Attributes | PrimaryPredicate | ReferenceDevice | ReferenceDevice | ReferenceDevice | ReferenceDevice | ProposedDevice | Similarities andDifferences |
| InclusiveAbutments | XpeedAnyRidgeImplant System | InclusiveTitaniumAbutments forAstraTechOsseoSpeedImplants | Hahn TaperedImplant System | InclusiveTaperedImplant System | InclusiveTitaniumAbutmentscompatiblewith: MegaGenAnyRidgeImplant System | ||
| 510(k) Number | K160979 | K140091 | K100993 | K143353 | K121406 | K170044 | N/A |
| Multi-UnitAbutments | Multi-UnitAbutments areprovided in 0°,17°, or 30°configurations | N/A | N/A | Multi-UnitAbutments areprovided in 0°,17°, or 30°configurations | N/A | Multi-UnitAbutments areprovided in 0°,17°, or 30°configurations | Same as HahnTaperedImplant(referenceK143353) |
| EstheticAbutments | N/A | AngledAbutment | N/A | N/A | N/A | AngledAbutment | Same asReference(K140091) |
| 4.5mm Non-EngagingAbutments | 4.5 mmHabutments havea 4 mm postheight | N/A | N/A | N/A | N/A | 4.5 mmHabutments havea 4 mm postheight | Same aspredicate(K160979) |
| 4.5/6.0mmEngagingAbutments | 4.5/6 mmHabutments havea 4 mm or 5.5mm postheights | N/A | N/A | N/A | N/A | 4.5/6 mmHabutments havea 4 mm or 5.5mm postheights | Same aspredicate(K160979) |
The Multi-Unit, Esthetic, and Engaging abutment connetries are hexagon shaped and there is no connection geometry for the nonengaging. Please note the 4.5 and 6.0 mm are for straight abutments only. The materials for all variations of abutments are the same, Ti-6AI-4V ELI.
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Image /page/11/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. On the left is a triangular prism with different colors. To the right of the prism is the company name in blue text.
Table 2A: Design Parameters (4.5 mm and 6.0 mm)
The subject device is substantially equivalent in indications and design principles to predicate devices shown above. Below is a summary table comparing the subject device, the primary predicate device and the additional reference predicate device.
| Subject Device | Primary Predicate Device | |
|---|---|---|
| Comparison | PrismatikDentalcraft, Inc.(K170044) | Inclusive Abutments(K160979) |
| Design | ||
| Abutment Design | Titanium Blank forCAD/CAM TitaniumAbutment forCAD/CAM | Titanium Blank forCAD/CAM TitaniumAbutment for CAD/CAM |
| Prosthesis Attachment | Cement-retainedScrew retained | Cement-retainedScrew retained |
| Restoration | Single-unitMulti-unit | Single-unit Multi-unit |
| Abutment PlatformDiameter | 3.5 - 8.4mm | 3.0-7.0mm |
| Abutment Angle | Straight only | Straight only |
| Material | ||
| Abutment | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
| Coping | Y-TZP | Y-TZP |
| Screw | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
Please note the 4.5 and 6.0 mm are for straight abutments only.
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Image /page/12/Picture/0 description: The image contains the logo for PRISMATIK DENTALCRAFT, INC. On the left side of the logo is a triangular shape with a gradient of colors, including pink, blue, yellow, and green. To the right of the triangle is the company name, "PRISMATIK DENTALCRAFT, INC.", written in blue font. The logo is simple and professional, and the use of color in the triangle adds a touch of creativity.
NON-CLINICAL TESTING (PERFORMANCE DATA) G.
The technological characteristics of the subject device have been verified to be essentially the same as the predicate device based on assessments of material composition, dimensional features, and mechanical properties. Non-clinical test data was used to determine substantial equivalence with predicate devices.
Non-clinical testing was performed in accordance with FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments".
Summary of Testing:
The technological characteristics of the Inclusive Titanium Abutments compatible with MegaGen AnyRidge Implant System have been verified to be essentially the same as the predicate devices based on assessments of materials composition, dimensional features, mechanical properties and biocompatibility of the implant and instrument materials.
Comparative testing was performed to show equivalence to the predicate device. This testing was performed according to ISO 14801:2007. This consisted of Reliability Calculation, Fatigue Testing and Static Load Failure Testing of finished assembled implant/abutment systems.
Reverse engineering analysis of critical features was performed on OEM implant bodies, OEM abutments, and OEM abutment fixation screws to establish compatibility.
The proposed device is made of the same material (medical grade titanium) as indicated in our reference devices K121406 and K143353. All the applicable Biocompatibility testing (Sensitization, Cytotoxicity, and Systemic Toxicity) has been conducted for these Devices. Hence, no additional biocompatibility testing was deemed necessary for this submission.
Sterile Product:
The Inclusive® Multi-Unit Abutments are provided sterilized via a minimum of 25KGy dose of gamma radiation to ensure SAL 10°. The sterilization dose was determined using the Method VDmax25 Dose Audit in accordance with ANSI/AAMI/ISO 11137-2:2013 Sterilization of Health Care Products - Radiation -Part 2: Establishing the Sterilization Dose.
Non-Sterile Product
Inclusive® Titanium Abutments compatible with: MegaGen and abutment screws are single-use devices, and are being shipped non-sterile, as they require further modification. After modification, and prior to clinical use, dental abutments and screws must be cleaned, disinfected, and sterilized according to a validated method, as described in the IFU. The recommended sterilization validation method is based on ANSI/AAMI ST79 and ISO 17665-1 and is provided in the reference predicates K160979 and K143353.
No clinical test data was used to support the decision of substantial equivalence.
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Conclusion:
In accordance with Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notifications the Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System is substantially equivalent to the predicate devices as described.
§ 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.)