Anthogyr FlexiBase® titanium bases for Axiom® BL are indicated for use as a support for singleunit customized prosthetic restorations. All digitally designed copings and / or crowns for use with the Anthogyr Flexibase® titanium bases for Axiom® BL are intended to be sent to Straumann for manufacturing by a validated milling center (Straumann CARES System).

Device Description

Anthogyr FlexiBase® titanium bases for Axiom® BL are intended to be placed into Anthogyr dental implants to provide support for single-unit restorations. The second component of the two-piece abutment (coping or crown) must be cemented onto the titanium component of the FlexiBase® abutment to constitute the final two-piece abutment design, which is then screwed onto the implant.

The bottom portion of the FlexiBase® are made from Titanium alloy. They are provided in several dimensions, there is one chimney height, and two platform diameters of 4.0 mm and 5.0 mm, and for each of the platform diameters there are three gingival heights of 1.5 mm, 2.5 mm and 3.5 mm.

Anthogyr FlexiBase® titanium bases for Axiom® BL are very similar to the primary predicate device Medentika TiBase CAD/CAM Abutments cleared in K150203.

The FlexiBase® are fixed in the implant by means of a prosthetic screw which is manufactured in titanium alloy and DLC coated identical to K161177.

The FlexiBase® abutments are two-piece abutments used as a base when fabricating a CAD/CAM customized restoration. The design and milling of the customized restoration must be made using the Straumann CARES® Visual software.

The FlexiBase® is a two-piece abutment ultimately composed by three components:

. FlexiBase® abutment titanium component
Top-half component (coping and/or crown) .
. Prosthetic screw

The FlexiBase® abutments will be marketed:

through a validated Straumann Centralized milling center, in this case all digitally . designed copings and/or crowns are intended to be manufactured at a validated Straumann milling center (Straumann CARES® System).

AI/ML Overview

The provided text describes a 510(k) premarket notification for "Anthogyr FlexiBase® titanium bases for Axiom® BL". This document focuses on demonstrating substantial equivalence to predicate devices, and therefore, the acceptance criteria and study detailed below relate to the performance of the device in comparison to these predicates, rather than proving a specific diagnostic accuracy or clinical outcome for a novel AI algorithm.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Specific Test/Standard	Acceptance Criteria	Reported Device Performance (Anthogyr FlexiBase®)
Sterilization	ISO 17665-1, ISO 17665-2, FDA Guidance "Reprocessing Medical Devices..."	Validation of recommended sterilization method for end-user moist heat (steam) sterilization.	Sterilization method validated according to ISO 17665-1 and ISO 17665-2 and applicable FDA guidance. Parameters equivalent to predicate devices.
Biocompatibility	ISO 10993-1, ISO 10993-5, FDA Guidance "Use of International Standard ISO 10993-1..."	Biological assessment performed, cytotoxicity testing conducted. Equivalent materials to predicate devices.	Biological assessment performed. Cytotoxicity testing performed as per ISO 10993-5. No new issues raised due to material equivalence to predicate devices.
Electromagnetic Compatibility (EMC)	Not explicitly stated, referenced from prior testing/clearance (K180564)	MR Conditional status due to no significant material/dimension changes from marketed predicate devices.	Considered MR Conditional. No new issues of electromagnetic compatibility raised due to physical equivalence to predicate devices.
Dynamic Fatigue	FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments", ISO 14801	Covered permanent restoration without failure for 2 million cycles (in saline, 2 Hz, 37°C); Covered temporary restoration without failure for 200,000 cycles (in saline, 2 Hz, 37°C).	Demonstrated equivalence to primary predicate and reference devices. Tested without failure for 2 million cycles (permanent restoration) and 200,000 cycles (temporary restoration) under specified conditions.

2. Sample size used for the test set and the data provenance

The document does not detail specific "sample sizes" in the context of a statistical test set using patient data. The performance testing described relates to in-vitro bench testing of the devices themselves.

Dynamic Fatigue Testing: The document states the test was conducted on the devices, but the specific number of units tested is not provided ("the subject devices").
Data Provenance: Not applicable in the context of clinical patient data. The testing described is laboratory-based bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable. The device is a physical dental implant component, and the testing described is engineering performance testing (sterilization, biocompatibility, fatigue). There is no "ground truth" to be established by clinical experts in the context of this 510(k) submission.

4. Adjudication method for the test set

Not applicable, as this is laboratory bench testing, not a clinical study involving human judgment on a test set.

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

Not applicable. The device is a dental implant base, not an AI, imaging, or diagnostic device that would involve human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. The performance criteria are based on engineering standards and regulatory guidance for device performance and safety (e.g., ability to withstand dynamic loading, biocompatibility, sterility) rather than clinical "ground truth" derived from patient data or expert consensus on clinical findings.

8. The sample size for the training set

Not applicable. This is not an AI algorithm or a device requiring a training set in that sense.

9. How the ground truth for the training set was established

Not applicable.

Summary of the Study Proving Acceptance Criteria:

The study proving the device meets the acceptance criteria is detailed under "Performance Testing - Bench" and "Performance Testing 1.1 - Sterilization Validation and Shelf-life", as well as "Biocompatibility Testing" and "Electromagnetic Compatibility".

Study Design: The studies essentially comprised benchtop engineering tests performed according to recognized international standards and FDA guidance documents. This included:
- Sterilization Validation: Demonstrated the effectiveness of the recommended moist heat (steam) sterilization method for end-users, aligning with ISO 17665-1, ISO 17665-2, and FDA guidance.
- Biocompatibility Testing: Conducted biological assessment according to ISO 10993-1 and ISO 10993-5, including cytotoxicity testing. The materials were deemed equivalent to those in predicate devices, implying comparable biocompatibility.
- Electromagnetic Compatibility (EMC): Assessed by confirming no significant changes in materials and dimensions compared to previously cleared predicate devices, thus inferring MR Conditional status based on prior clearances (e.g., K180564).
- Dynamic Fatigue Testing: Conducted in accordance with FDA guidance for endosseous dental implants and ISO 14801. This involved cyclic loading tests in saline (2 Hz, 37°C) for:
  - 2 million cycles for permanent restorations (without failure).
  - 200,000 cycles for temporary restorations (without failure).
Proof of Meeting Acceptance Criteria: The outcome of these tests indicated that the "Anthogyr FlexiBase® titanium bases for Axiom® BL" devices successfully met the performance requirements outlined by the respective standards and guidance documents. The key finding was that the subject devices demonstrated equivalence to the primary predicate and reference devices in all these aspects of performance and safety. This equivalence is the primary basis for the 510(k) clearance.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "U.S. Food & Drug Administration" in blue.

January 4, 2024

Anthogyr % Jennifer Jackson Sr. Dir, Regulatory & Quality NAM Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01801

Re: K231072

Trade/Device Name: Anthogyr FlexiBase® titanium bases for Axiom® BL Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: December 5, 2023 Received: December 5, 2023

Dear Jennifer Jackson:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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

Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K231072

Device Name

Anthogyr FlexiBase® titanium bases for Axiom® BL

Indications for Use (Describe)

Anthogyr FlexiBase® titanium bases for Axiom® BL are indicated for use as a support for single-unit customized prosthetic restorations. All digitally designed copings and / or crowns for use with the Anthogyr Flexibase® titanium bases for Axiom® BL are intended to be sent to Straumann for manufacturing by a validated milling center (Straumann CARES System).

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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K231072 - Anthogyr FlexiBase® titanium bases for Axiom® BL

510(k) Summary

Submitter's Contact Information

Submitter:	Straumann USA, LLC (on behalf of Anthogyr)60 Minuteman RoadAndover, MA 01810Registration No.: 1222315 Owner/Operator No.: 9005052
	On the behalf of:
	Anthogyr2 237 Avenue André Lasquin74700 Sallanches, France
Contact Person:	Jennifer M. Jackson, MS, RACSr. Director, Regulatory Affairs and QualityPhone Number: +1 978 747-2509Fax Number: +1 978 747-0023
Prepared By &Alternate Contact:	Estelle SALLERegulatory Affairs Project ManagerAnthogyrPhone number: +33 (0)4 50 58 02 37
Date of Submission:	January 4, 2024

Name of the Device

Trade Names:	Anthogyr FlexiBase® titanium bases for Axiom® BL
Common Name:	Endosseous dental implant abutment (21 CFR 872.3630)
Classification Name:	Endosseous dental implant abutment (21 CFR 872.3630)
Regulation Number:	§872.3630
Device Classification:	II
Product Code(s):	NHA
Classification Panel:	Dental

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K231072 - Anthogyr FlexiBase® titanium bases for Axiom® BL

Predicate Device(s)

Primary Predicate:

K150203 Medentika CAD/CAM Abutments .
Reference Devices:
K222836 Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia Discs .
K190082 Straumann BLX Variobase Abutment .
. K173961 – Straumann BLX Implant System
K170354 Straumann® Variobase® Abutments .

Compatible Dental Implants:

K161177 Axiom PX .
K131066 Axiom Reg .
K101913 Anthofit Ol, Anthofit HE, Ossfit, and Axiom .

Device Description

Anthogyr FlexiBase® titanium bases for Axiom® BL

Anthogyr FlexiBase® titanium bases for Axiom® BL are very similar to the primary predicate device Medentika TiBase CAD/CAM Abutments cleared in K150203.

The FlexiBase® are fixed in the implant by means of a prosthetic screw which is manufactured in titanium alloy and DLC coated identical to K161177.

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K231072 - Anthogyr FlexiBase® titanium bases for Axiom® BL

The FlexiBase® is a two-piece abutment ultimately composed by three components:

. FlexiBase® abutment titanium component
Top-half component (coping and/or crown) .
. Prosthetic screw

The FlexiBase® abutments will be marketed:

through a validated Straumann Centralized milling center, in this case all digitally . designed copings and/or crowns are intended to be manufactured at a validated Straumann milling center (Straumann CARES® System).

Prosthetic Restoration Design and Materials

The following is an overview of the possible coping materials:

n!ce CoCr .
n!ce Zr LT
. n!ce Zr HT
. n!ce Zr XT
. n!ce glass ceramic
. n!ce PMMA (temporary)

The design of the digital coping and/or crown should follow the standard procedure according to the material manufacturer's instructions for use and Anthogyr's instructions for use.

Anthogyr prosthetic screw

A prosthetic screw is used to fix abutments to dental implants. The screw is provided with the abutments and also available standalone (replacement).

The prosthetic screws are manufactured from titanium alloy and are DLC coated identical to K161177.

Intended Use

FlexiBase® titanium bases for Axiom® BL are intended to support screw-retained restorations on Axiom® BL dental implants.

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K231072 - Anthogyr FlexiBase® titanium bases for Axiom® BL

Indications for Use

Technological Characteristics

The technological characteristics of the subject devices are compared to the primary predicate and reference devices in the following tables:

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K231072 - Anthogyr FlexiBase® titanium bases for Axiom® BL

	PROPOSED DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE DEVICE
FEATURE	Subject Device - AnthogyrFlexiBase® titanium basesfor Axiom® BL	Medentika CAD/CAM AbutmentsK150203	Straumann BLX VariobaseAbutmentK190082	Straumann BLX ImplantSystemK173961	Straumann® Variobase®AbutmentsK170354
Indication foruse	Anthogyr FlexiBase®titanium bases for Axiom®BL are indicated for use asa support for single-unitcustomized prostheticrestorations. All digitallydesigned copings and / orcrowns for use with theAnthogyr Flexibase®titanium bases for Axiom®BL are intended to be sentto Straumann formanufacturing by avalidated milling center(Straumann CARESSystem).	Medentika CAD/CAM abutments areintended for use with dental implantsas a support for single or multipletooth prostheses in the maxilla ormandible of a partially or fullyedentulous patient.Abutments are compatible with thefollowing implant systems:E-Series: Nobel Biocare Replace™Select 3.5, 4.3, 5.0, 6.0 F-Series: Nobel BiocareNobelActive™ 3.5, 4.3, 5.0 H-Series: Biomet 3i Osseotite Certain3.25, 4.0, 5.0 I-Series: Biomet 3i Osseotite 3.25,3.75, 4.0, 5.0 K-Series: Nobel Biocare Brånemark3.3, 3.75, 4.0, 5.0 L-Series: Straumann Bone Level 3.3,4.1, 4.8 N-Series: Straumann Standard 3.3,4.1, 4.8 R-Series: Zimmer Tapered Screw-Vent 3.3, 3.7, 4.1, 4.7, 6.0 S-Series: Astra Tech OsseoSpeed3.5/4.0, 4.5/5.0 T-Series: Dentsply FriadentFrialit/XiVE 3.4, 3.8, 4.5, 5.5 Y-Series: Dentsply Friadent Ankylos3.5, 4.5, 5.5, 7.0 Medentika TiBase is intended for usewith the Straumann® CARES® System.	Straumann® Variobase®prosthetic components directlyor indirectly connected to theendosseous dental implantare intended for use as an aidin prosthetic rehabilitations.The prosthetic restoration(crowns) can be cementedonto the Straumann®Variobase®prosthetic components. Atemporary restoration can beused prior to the insertion ofthe final components tomaintain, stabilize and shapethe soft tissue during thehealing phase; they must beplaced out of occlusion. Finalabutments and restorationsmay be placed into occlusionwhen the implant is fullyosseointegrated. All digitallydesigned copings and/orcrowns for use with theStraumann® Variobase®Abutment system areintended to be sent toStraumann for manufacture ata validated milling center.	Straumann® Variobase®prosthetic components directlyor indirectly connected to theendosseous dental implant areintended for use as an aid inprosthetic rehabilitations.The prosthetic restoration(crowns) can be cemented ontothe Straumann® Variobase®prosthetic components. Atemporary restoration can beused prior to the insertion of thefinal components to maintain,stabilize and shape the softtissue during the healing phase;they must be placed out ofocclusion. Final abutments andrestorations may be placed intoocclusion when the implant isfully osseointegrated. All digitallydesigned copings and/or crownsfor use with the Straumann®Variobase® Abutment systemare intended to be sent toStraumann for manufacture at avalidated milling center.	The Straumann®Variobase™ Abutment isa titanium base placedonto Straumann dentalimplants to providesupport for customizedprosthetic restorations.Straumann® Variobase™Abutments are indicatedfor screw-retained singletooth or cement retainedsingle tooth and bridgerestorations.
Material	Titanium: 3.7165.1-Ti-6Al-4VELI	Titanium Alloy: Ti-6Al-4V ELI	Ti-6Al-7Nb	Ti-6Al-7Nb	Titanium-Aluminum-Niobium alloy (Ti-6Al-7Nb)
Abutmentdiameters	Ø4 mm and Ø5 mm	Ø 3.0 - 7.0 mm	Ø 3.8 to 5.5 mm	Ø 3.8, 4.5, and 5.5 mm	Ø 3.8 - 7.0 mm
	PROPOSED DEVICEPRIMARY PREDICATE DEVICEREFERENCE DEVICE
FEATURE	Subject Device - AnthogyrFlexiBase® titanium basesfor Axiom® BL	Medentika CAD/CAM AbutmentsK150203	Straumann BLX VariobaseAbutmentK190082	Straumann BLX ImplantSystemK173961	Straumann® Variobase®AbutmentsK170354
TitaniumcomponentGingivalheight(s)*	1.5, 2.5 and 3.5 mm*	-	0.75 - 3.5 mm*	0.75 - 2.5 mm*	-
Titaniumcomponentchimneyheight(s)*	3.5 mm*	4 mm - 5.5 mm*	4 mm and 6 mm*	-	3.5 – 4.5 mm*
MinimumAbutmentPost Heightabove thegingivalmargin of thefinal design	4 mm	4 mm	4 mm	4 mm	4 mm
Restorationtype	Single-unit	Single or multiple toothprostheses	Screw-retained single-unit, orCement-retained single ormulti-unit	-	-
Top-halfmaterials	n!ce CoCrn!ce Zr LTn!ce Zr HTn!ce Zr XTn!ce® glass ceramicn!ce PMMA (temporary)	Zirconia	coron®zerion® LTzerion® ML and UTML	IPS e.max CADPolycon® ae	Coron®Zerion®IPS e.max CADn!cePolycon® ae
Abutmentangulation	Up to 30°	Up to 30°	Up to 30°	Up to 30°	Up to 30°
Prosthesisattachment	Screw-retained	Cement retained	Cement retained	Screw-retained or cementretained	Screw-retained orcement retained
Cement usedin deviceperformancetesting	PANAVIA V5 by KURARAYDENTAL, cleared by FDAunder K150704	Multilink Hybrid AbutmentCement by Ivoclar (K130436).	Kuraray Panavia V5	Kuraray Panavia V5	-
	PROPOSED DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE DEVICE
FEATURE	Subject Device - AnthogyrFlexiBase® titanium basesfor Axiom® BL	Medentika CAD/CAM AbutmentsK150203	Straumann BLX VariobaseAbutmentK190082	Straumann BLX ImplantSystemK173961	Straumann® Variobase®AbutmentsK170354
Cement to fixpatient-specificcopingaccording toIFU	PANAVIA V5 by KURARAYDENTAL, cleared by FDAunder K150704	Multilink Hybrid AbutmentCement by Ivoclar (K130436).	Kuraray Panavia V5	Kuraray Panavia V5	-
Geometrydefinitionworkflow	Straumann CARES systemvalidated centralized millingcenter under manufacturingcontrol	Straumann CARES systemvalidated centralized millingcenter under manufacturingcontrol	Wax-up or StraumannCARES® Visual, DentalWings software using theStraumann CARES VisualPlug-In and 3Shape	Wax-up or Straumann CARES®Visual, Dental Wings softwareusing the Straumann CARESVisual Plug-In and 3Shape	Wax-up or StraumannCARES® Visual, DentalWings software using theStraumann CARESVisual Plug-In and3Shape
Manufacturingworkflow	Straumann Milling Center	Straumann Milling Center	Straumann Milling Center	Straumann Milling Center	Traditional casting orpressing or StraumannMilling Center
Reusable	No, single-use	No, single-use	No, single-use	No, single-use	No, single-use
Sterility	Non sterile - End usersterilization by autoclave	Non sterile - End usersterilization by autoclave	Non sterile - End usersterilization by autoclave	Non sterile - End usersterilization by autoclave	Non sterile - End usersterilization by autoclave

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K231072 - Anthogyr FlexiBase® titanium bases for Axiom® BL

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K231072 - Anthogyr FlexiBase® titanium bases for Axiom® BL

*This dimension is referring to the stock titanium FlexiBase Component only.

Table 1 – Comparison of subject device (Anthogyr FlexiBase® titanium bases for Axiom® BL uses with Straumann CARES

System – Validated centralized milling center)

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Anthogyr FlexiBase® titanium bases for Axiom® BL

Appendix 8

Performance Testing 1.1 -

Sterilization Validation and Shelf-life

The subject devices are provided non-sterile and need to be sterilized by moist heat (steam) by the end-user. The recommended sterilization method has been validated according to ISO 17665-1 and ISO 17665-2 and applicable recommendations in the FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015". The sterilization methods and parameters are equivalent to the primary predicate and reference devices.

Biocompatibility Testing

Biological assessment has been performed according to ISO 10993-1 "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" and to the FDA Guidance document "Use of International Standard ISO 10993- 1, 'Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process', Guidance for Industry and Food and Drug Administration Staff, Document issued on: June 16, 2016" for each of the subject devices. Cytotoxicity testing was performed on the subject devices per ISO 10993-5.

The subject devices are equivalent in material to the primary predicate and reference devices, therefore, no new issues regarding biocompatibility were raised.

Electromagnetic Compatibility

There are no significant changes to the materials and dimensions from the currently marketed predicate devices. Therefore, no new issues of electromagnetic compatibility are raised for the subject devices and they can be considered MR Conditional. MR Conditional labeling is referenced from prior testing/clearance (K180564).

Performance Testing - Bench

Dynamic fatique testing was conducted according to the FDA quidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and ISO 14801 "Dentistry — Implants — Dynamic loading test for endosseous dental implants" and demonstrated the subject devices are equivalent to the primary predicate and reference devices. The test was conducted in saline (2 Hz and 37 °C) at 2 million cycles covering permanent restoration of the Anthogyr FlexiBase®

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Anthogyr FlexiBase® titanium bases for Axiom® BL

Appendix 9

titanium bases for Axiom® BL without failure. Test was conducted in saline (2 Hz and 37 °C at 200,000 cycles covering the temporary restoration of the Anthogyr FlexiBase® titanium bases for Axiom® BL without failure.

Conclusion

The documentation submitted in this premarket notification demonstrates the subject devices are substantially equivalent to the primary predicate and reference devices.

Regulation Number and Section

§ 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.)