The implant system is intended to be surgically placed in the maxilla or mandible to provide support for prosthetic devices such as artificial teeth in order to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly splinted.

Anthogyr Multi-Unit prosthetic components directly or indirectly connected to the endosseous dental implants are indicated for use to provide support for multiple-unit prosthetic reconstructions such as bridges and bars. The final devices have the purpose of restoring chewing function. Temporary components can be used prior to the final components to maintain, stabilize and shape the soft tissue during the healing phase. The temporary restoration may not be placed into occlusion.

Temporary components have a maximum duration of usage of 180 days.

The OPMUN0-0 abutments are indicated for maxillary lateral and mandibular central/lateral incisors only.

Device Description

The Anthogyr AXIOM® BL X3 implants are fully tapered dental bone level implants with external diameters of Ø3.4 mm, Ø4.6 mm, Ø5.2 mm, Ø5.8 mm and Ø6.4 mm and lengths of 6.5 mm, 8 mm, 10 mm, 12 mm, 16 mm, and 18 mm. The implants are manufactured from the Ti 6Al-4V ELI titanium-vanadium alloy material and are finished with BCP (Biphasic Calcium Phosphates) surface treatment. The abutment connection is identified as single conical connection.

The proposed Anthogyr Multi-Unit abutments for AXIOM® BL are dental abutments, which are intended to be screwed onto dental implants to provide support for prosthetic superstructures. Multi-Unit abutments can be used in combination with screw retrained multi-unit dental prosthetics, e.g., bars and bridges. Anthogyr Multi-Unit abutments for AXIOM® BL are very similar to the reference device Medentika Multi-Unit Abutments cleared in K191123.

Anthogyr Multi-Unit abutments for AXIOM® BL include straight and angled (18° and 30°) abutments, prosthetic screw and abutment carrier pin.

Anthoqyr Multi-Unit abutments are available as one-piece straight abutments, which have an integrated thread and can be screwed directly into the AXIOM® Bone Level implants, or as twoparts angled abutments, which can be screwed onto the AXIOM® Bone Level implant with the corresponding M1.6 screw.

Anthogyr Multi-Unit abutments for AXIOM® BL exist in two model types:

Straight Multi-Unit abutments with various gingival heights and two platform diameters । (Ø 4.0 and Ø 4.8 mm)
Angulated Multi-Unit abutments with various gingival heights and angulations.

Anthogyr Multi-Unit protective caps are placed to the Multi-Unit abutments and are intended to be used to protect the abutment and maintain, stabilize and form the soft tissue during the healing phase.

Anthogyr Multi-Unit temporary copings are compatible with the Multi-Unit abutments and are used for temporary restorations. The copings are placed on the Multi-Unit abutments to support temporary prosthetic superstructures. Temporary copings can be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase. They must not be placed into occlusion.

The Multi-Unit temporary copings can be adjusted by the dental technician to fit the oral situation and are fixed to a compatible Multi-Unit abutment by a M1.4 screw.

Anthogyr Flexibase for Multi-Unit abutments are compatible with the Multi-Unit abutments and are used for multiple-unit definitive restorations. The Flexibase are placed on Multi-Unit abutments to support definitive prosthetic superstructures. They are fixed to a compatible Multi-Unit abutment by a M1.4 screw.

AI/ML Overview

The provided text describes a 510(k) summary for Anthogyr AXIOM® BL X3 implants and Anthogyr Multi-Unit components for AXIOM® BL. This document evaluates the substantial equivalence of new devices to existing legally marketed predicate devices, rather than establishing acceptance criteria and providing direct evidence of device performance against those criteria in a typical clinical study format.

Therefore, the requested information elements related to "acceptance criteria and reported device performance tabletop," "sample size for test set," "data provenance," "number of experts and qualifications," "adjudication method," "multi-reader multi-case (MRMC) comparative effectiveness study," "standalone performance," "type of ground truth," "sample size for training set," and "how ground truth for training set was established" are not applicable in the context of this 510(k) submission summary.

This document focuses on demonstrating that the new devices are substantially equivalent to predicate devices through comparisons of technological characteristics and performance testing (e.g., dynamic fatigue, biocompatibility, sterilization validation). The "acceptance criteria" here implicitly refer to demonstrating equivalence to the predicate devices and compliance with relevant standards and FDA guidance.

Here's an overview of the performance testing performed, interpreted as demonstrating compliance/equivalence rather than explicitly stated acceptance criteria with numerical performance targets:

1. Acceptance Criteria and Reported Device Performance:

Criteria/Performance Aspect	Description/Reported Performance
Mechanical Performance	Dynamic Fatigue Tests: Conducted following FDA guidance "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments." Demonstrated equivalence to predicate and reference devices. The specific fatigue limits (acceptance criteria) and detailed results are not provided in this summary but are implied to be met for equivalence.
Biocompatibility	Material Comparison: Subject device materials are identical to predicate and reference device materials. Minor differences in anodization required additional testing. Cytotoxicity Tests (for anodized parts): Conducted according to ISO 10993-5 "Biological Evaluation of Medical Devices, Part 5: Tests for In Vitro Cytotoxicity." Demonstrated non-cytotoxicity potential of the parts. No new issues regarding biocompatibility were raised.
Sterilization	Sterility Assurance Level (SAL): For Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit abutments for AXIOM® BL, and Anthogyr Multi-Unit protective caps (provided sterile via gamma irradiation), SAL of 10⁻⁶ validated according to ISO 11137-1. Sterilization Process (for Multi-Unit restorations and prosthetic screws): Validated according to ISO 17664 and ISO 17665-1 (for moist heat sterilization by end-user).
Implant Characteristics	Surface Area, Bone-to-Implant Contact, Pullout Strength: Compared to a reference device (K033922). Results were substantially equivalent. (Specific numerical acceptance criteria and performance values are not provided in this summary).
Electromagnetic Compatibility (EMC) & Safety	No significant changes to materials/dimensions from cleared predicate devices. Declared as MR Conditional based on FDA Guidance "Testing and Labeling Medical Devices for Safety in Magnetic Resonance (MR) Environment." MR Conditional tests were conducted. (This suggests the device meets the safety requirements for being used in an MR environment under specified conditions).

2. Sample Size Used for the Test Set and Data Provenance:

This information is not provided in the 510(k) summary. The summary refers to "tests were conducted" and "results were substantially equivalent," but actual sample sizes for mechanical, sterilization, or other tests are not detailed. The data provenance (e.g., country of origin, retrospective/prospective) is also not mentioned.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable. This is a medical device, not an AI/software device requiring ground truth established by experts for a test set. The "ground truth" for non-AI devices is typically established through direct physical measurements, chemical analyses, and standardized test methodologies.

4. Adjudication Method for the Test Set:

Not applicable.

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. This is not an AI/imaging device.

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

Not applicable. This is not an AI/software device.

7. The Type of Ground Truth Used:

For a traditional medical device like a dental implant, "ground truth" refers to established physical, chemical, and biological properties measured through standardized testing. Examples include:
- Mechanical properties: Measured against international standards (e.g., ISO, ASTM) or FDA guidance for dental implants/abutments (e.g., fatigue strength, fracture resistance).
- Biocompatibility: In vitro (e.g., cytotoxicity tests under ISO 10993-5) and in vivo tests (if new materials are introduced) against established biological safety profiles.
- Sterilization efficacy: Measured by demonstrating a Sterility Assurance Level (SAL) of 10⁻⁶ via methods compliant with ISO 11137-1 (radiation) or ISO 17665-1 (moist heat).
- Material composition: Chemical analysis to confirm compliance with medical-grade specifications (e.g., Titanium-6Al-4V ELI conforming to ASTM F136).

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/software device that uses a "training set."

9. How the Ground Truth for the Training Set Was Established:

Not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.

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

Re: K230104

Trade/Device Name: Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: September 15, 2023 Received: September 18, 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 (QS) 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 medical devices and radiation-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) K230104

Device Name Anthogyr AXIOM® BL X3 Implants

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	□ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Indications for Use

510(k) Number (if known) K230104

Device Name

Anthogyr Multi-Unit components for AXIOM® BL

Indications for Use (Describe)

Temporary components have a maximum duration of usage of 180 days.

The OPMUN0-0 abutments are indicated for maxillary lateral and mandibular central/lateral incisors only.

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

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Anthogyr AXIOM® BL X3 implants and Anthogyr Multi-Unit components for AXIOM® BL

510(k) Summary - K230104

510(k) Summary

Submitter's Contact Information

Submitter:	Straumann USA, LLC
	60 Minuteman Road
	Andover, MA 01810
	Registration No.: 1222315	Owner/Operator No.: 9005052
	On the behalf of:
	Anthogyr
	2237 Av. André Lasquin,
	74700 Sallanches, France
	Registration No.: 8020776	Owner/Operator No.: 9005052
	Jennifer M. Jackson, MS, RAC
	Senior Director, Regulatory Affairs and Quality NAMPhone Number: +1 978 747-2509
	Fax Number: +1 978 747-0023
Prepared By &	Aude GOULET/Estelle SALLE
Alternate Contact:	Regulatory Affairs Project Manager
	Anthogyr
	Phone number: +33450580237
Date of Submission:	October 12, 2023
Name of the Device

Trade Names:	Anthogyr AXIOM® BL X3 implants and Anthogyr Multi-Unitcomponents for AXIOM® BL
Common Name:	Endosseous dental implant

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Anthogyr AXIOM® BL X3 implants and Anthogyr Multi-Unit components for AXIOM® BL

510(k) Summary - K230104

Classification Name:	Endosseous dental implant
Regulation Number:	21 CFR 872.3640
Device Classification:	II
Product Code(s):	DZE, NHA
Classification Panel:	Dental
Proprietary Name:	Anthogyr AXIOM® BL X3 implants and Anthogyr Multi-Unitcomponents for AXIOM® BL

Predicate Device(s)

Primary Predicate:

K203309 NUVO CF Implant System .

Reference Devices:

. K161177 – AXIOM® PX
K173961 Straumann BLX Implant System .
K131066 Axiom® REG .
. K101913 – ANTHOGYR DENTAL IMPLANT SYSTEMS : AXIOM
. K191123 – Medentika Multi-unit Abutments
. K192401 – Straumann® Screw-Retained Abutments
K133421 Straumann® Magellan Abutment System .
. K220251 – Neodent Implant System – GM Narrow Implant System
K033922 Straumann® Modification to ITI Dental Implant System .

Device Description

Subject implants

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Anthogyr AXIOM® BL X3 implants and Anthogyr Multi-Unit components for AXIOM® BL

510(k) Summary - K230104

from the Ti 6Al-4V ELI titanium-vanadium alloy material and are finished with BCP (Biphasic Calcium Phosphates) surface treatment. The abutment connection is identified as single conical connection.

Subject prosthetic components

Anthogyr Multi-Unit abutments for AXIOM® BL

Anthogyr Multi-Unit abutments for AXIOM® BL include straight and angled (18° and 30°) abutments, prosthetic screw and abutment carrier pin.

Anthogyr Multi-Unit abutments for AXIOM® BL exist in two model types:

Straight Multi-Unit abutments with various gingival heights and two platform diameters । (Ø 4.0 and Ø 4.8 mm)
Angulated Multi-Unit abutments with various gingival heights and angulations.

Anthogyr Multi-Unit protective caps

Anthogyr Multi-Unit temporary copings

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Anthogyr AXIOM® BL X3 implants and Anthogyr Multi-Unit components for AXIOM® BL

510(k) Summary - K230104

the final components to maintain, stabilize and shape the soft tissue during the healing phase. They must not be placed into occlusion.

The Multi-Unit temporary copings can be adjusted by the dental technician to fit the oral situation and are fixed to a compatible Multi-Unit abutment by a M1.4 screw.

Anthoqyr Flexibase for Multi-Unit abutments

Intended Use

Subject implants

Anthogyr dental implants are suitable for endosteal implantation in the maxilla or mandible and for the functional and esthetic oral rehabilitation of patients with missing teeth.

Subject prosthetic components

Anthogyr Multi-Unit abutments are intended to be placed into AXIOM® BL implants to provide support for multi-unit prosthetic reconstructions such as bridges and bars. Copings are fixed to the Multi-Unit abutments in order to provide support for prosthetic reconstructions such as bridges and bars.

Indications for Use

Subject implants

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Anthogyr AXIOM® BL X3 implants and Anthogyr Multi-Unit components for AXIOM® BL

510(k) Summary - K230104

Subject prosthetic components

Anthogyr Multi-Unit prosthetic components directly connected to the endosseous dental implants are indicated for use to provide support for multiple-unit prosthetic reconstructions such as bridges and bars. The final devices have the purpose of restoring chewing function. Temporary components can be used prior to the installation of the final components to maintain, stabilize and shape the soft tissue during the healing phase. The temporary restoration may not be placed into occlusion.

Temporary components have a maximum duration of usage of 180 days.

The OPMUN0-0 abutments are indicated for maxillary lateral and mandibular central/lateral incisors only.

Technological Characteristics Comparison Tables

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

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Anthogyr AXIOM® BL X3 implants and Anthogyr Multi-Unit components for AXIOM® BL

510(k) Summary - K230104

	SUBJECT DEVICE	PRIMARYPREDICATE DEVICE	REFERENCE DEVICES
FEATURES	K230104	K203309	K161177	K173961	K131066	K101913	K033922
	Anthogyr AXIOM® BLX3 implants	NUVO CF ImplantSystem	AXIOM® PX	Straumann BLXImplant System	Axiom® REG	Anthogyr DentalImplant Systems:AXIOM	Straumann®Modification to ITIDental ImplantSystem
Indications for Use	The implant system isintended to besurgically placed in themaxilla or mandible toprovide support forprosthetic devicessuch as artificial teethin order to restorechewing function. Itmay be used withsingle-stage or two-stage procedures, forsingle or multiple unitrestorations, and maybe loaded immediatelywhen good primarystability is achievedand with appropriateocclusal loading.Multiple toothapplications may berigidly splinted.	The Implant System isintended to besurgically placed in themaxilla or mandible toprovide support forprosthetic devicessuch as artificial teethin order to restorechewing function. Itmay be used withsingle-stage or two-stage procedures, forsingle or multiple unitrestorations, and maybe loaded immediatelywhen good primarystability is achievedand with appropriateocclusal loading.Multiple toothapplications may berigidly splinted.	Anthogyr dentalimplants are intendedfor use as artificial rootstructures forreplacement ofmissing teeth. Theycan be used forstabilization ofremovable prosthesesor fixation of singletooth restorations orpartial dentures.Anthogyr dentalsystems are indicatedfor one-stage or two-stage surgery.It is upto the practitioner todecide whetherimmediate or delayedloading is mostappropriate, based onclinical factors likegood primary stabilityand appropriateocclusal loading.	Straumann® BLXImplants are suitablefor endostealimplantation in theupper and lower jawand for the functionaland esthetic oralrehabilitation ofedentulous andpartially edentulouspatients. BLX Implantscan be placed withimmediate function onsingle-toothapplications whengood primary stabilityis achieved and withappropriate occlusalloading to restorechewing function. Theprosthetic restorationsare connected to theimplants through thecorrespondingabutment components.	Anthogyr AXIOM® REGimplants are intendedfor use as artificial rootstructures forreplacement of missingteeth. They can be usedfor stabilization ofremovable prosthesesor fixation of single toothrestorations or partialdentures.The Axiom dentalsystem is indicated forone-stage or two-stagesurgery.It is up to thepractitioner to decidewhether immediate ordelayed loading is mostappropriate, based onclinical factors like goodprimary stability andappropriate occlusalloading.Prefabricatedcomponents areintended for use asaccessories to dentalimplants to supportimplant-supportedrestorations.	Both Dental ImplantSystems are intendedfor use in partially orfully edentulousmandibles andmaxillae, in support ofsingle or multiple-unitrestorations including;cement retained,screw retained oroverdenturerestorations, andterminal orintermediate abutmentsupport for fixedbridgework.	ITI implants areintended for surgicalplacement in themaxillary and/ormandibular arches toprovide support forprosthetic restorationin edentulous orpartially edentulouspatients. ITI DentalImplants are for single-stage or two-stagesurgery.ITI Dental Implants areintended for immediateplacement andfunction on single-tooth and/or multipletooth applicationswhen good primarystability is achieved,with appropriateocclusal loading, inorder to restorechewing function.Multiple toothapplications may berigidly splinted. In thecase of edentulouspatients, four or moreimplants must beused.
	SUBJECT DEVICE	PRIMARYPREDICATE DEVICE	REFERENCE DEVICES
	K230104	K203309	K161177	K173961	K131066	K101913	K033922
FEATURES	Anthogyr AXIOM® BLX3 implants	NUVO CF ImplantSystem	AXIOM® PX	Straumann BLXImplant System	Axiom® REG	Anthogyr DentalImplant Systems:AXIOM	Straumann®Modification to ITIDental ImplantSystem
Implant type	Bone Level	Bone Level	Bone Level	Bone Level	Bone Level	Bone Level	Tissue Level
Implant to Abutmentinterface	2.7 mm diameterconical Morse taperconnection with tri-lobe	Internal Hex	2.7 mm diameterconical Morse taperconnection with tri-lobe	BLX (with conicalfitting)	2,7 mm diameterconical Morse taperconnection with tri-lobe	2,7 mm diameterconical Morse taperconnection with tri-lobe	Straumann® synOcta®connection
Implant Diameter	Ø 3.4 mm, 4.0 mm, 4.6mm, 5.2 mm, 5.8mmand 6.4 mm	Ø 3.5 mm, 3.75 mm,4.0, 4.3 mm and 5.0mm	Ø 3.4 mm, 4.0 mm, 4.6mm, and 5.2 mm	Ø 4.5 mm, 5.5 mm, 6.5mm	Ø 3.4 mm and 4.0 mm	Ø 3.4 mm, 4.0 mm, 4.6mm and 5.2 mm	Ø 3.3mmØ 4.1mmØ 4.8mm
Implant Length	Ø 3.4 mm : 8, 10, 12,14, 16 and 18 mm4.0 mm : 6.5, 8, 10,12, 14, 16 and 18 mm4.6 mm : 6.5, 8, 10, 12and 14 mm5.2 mm : 6.5, 8, 10and 12 mm5.8mm : 6.5, 8, 10 and12 mm6.4 mm : 6.5, 8, 10,12mm	3.5 mm: 8, 10, 11.5,13, 16 & 18 mm3.75 mm: 8, 10, 11.5,13, 16 & 18 mm4.0 mm: 7, 8, 10,11.5, 13, 16 & 18 mm4.3 mm: 7. 8, 10,11.5, 13, 16 & 18 mm5.0 mm: 7, 8, 10, 11.5,13 & 16 mm	3.4 mm: 8, 10, 12, 14,16 and 18 mm4.0 mm : 8, 10, 12, 14,16 and 18 mm4.6 mm : 6.5, 8, 10, 12and 14 mm5.2 mm : 6.5, 8, 10, 12mm	Ø 4.5 mm : 6, 8, 10,12, 14, 16 and 18 mmØ 5.5 mm : 6, 8, 10,and 12mmØ 6.5 mm : 6, 8, 10,and 12mm	Ø 3.4 mm : 16 and 18mmØ 4.0 mm: 16 and 18mm	Ø 3.4 mm : 8, 10, 12and 14 mmØ 4.0 mm : 6, 8, 10, 12and 14 mmØ 4.6 mm : 6, 8, 10, 12and 14 mmØ 5.2 mm : 6, 8, 10, 12and 14 mm	Ø 3.3mm : 8, 10, 12and 14 mmØ 4.1mm : 6, 8, 10, 12and 14 mmØ 4.8mm : 6, 8, 10, 12and 14 mm
Thread Design	Tapered body	Apically Tapered, DualHelix	Tapered body	Tapered body	Tapered body	Tapered body	Tapered body
Surface finish	Sand blasted and acidetched (BCP)	Sand blasted and acidetched (Neoporos)	Sand blasted and acidetched (BCP)	Hydrophilic SLActive®	Sand blasted and acidetched (BCP)	Sand blasted and acidetched (BCP)	SLA® - that is large-grit sandblasted andacid-etched
Material	Titanium-6Aluminum-4Vanadium ELI (grade23)	Commercially PureTitanium (Grade 4)	Titanium-6Aluminum-4Vanadium ELI (grade23)	Titanium-13 Zirconiumalloy (Roxolid®)	Titanium-6Aluminum-4Vanadium ELI (grade23)	Titanium-6Aluminum-4Vanadium ELI (grade23)	Titanium (Grade4)
Single Use	Yes	Yes	Yes	Yes	Yes	Yes	Yes

Table 1 - Technological Characteristic Comparison Table (Anthogyr AXIOM BL X3 Implants)

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Anthogyr AXIOM® BL X3 implants and Anthogyr Multi-Unit components for AXIOM® BL

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Anthogyr AXIOM® BL X3 implants and Anthogyr Multi-Unit components for AXIOM® BL

510(k) Summary - K230104
--------------------------

FEATURES	SUBJECT DEVICE	PRIMARYPREDICATE DEVICE	REFERENCE DEVICES
	K230104	K203309	K161177	K173961	K131066	K101913	K033922
	Anthogyr AXIOM® BLX3 implants	NUVO CF ImplantSystem	AXIOM® PX	Straumann BLXImplant System	Axiom® REG	Anthogyr DentalImplant Systems:AXIOM	Straumann®Modification to ITIDental ImplantSystem
Sterilization Method	Gamma Irradiation toan SAL of 1x10-6	Gamma Irradiation toan SAL of 1x10-6	Gamma Irradiation toan SAL of 1x10-6	Gamma Irradiation toan SAL of 1x10-6	Gamma Irradiation toan SAL of 1x10-6	Gamma Irradiation toan SAL of 1x10-6	Gamma Irradiation toan SAL of 1x10-6

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Anthogyr AXIOM® BL X3 implants and Anthogyr Multi-Unit components for AXIOM® BL

510(k) Summary - K230104

The subject implants have the same indications for use and an equivalent range of lengths as the primary predicate and reference devices, being contemplated within the range of lengths of the predicate devices.

Subject and predicate implants have the similar implant-to-abutment interface. Both present the same surfaces. The subject implants are manufactured of the similar materials and are sterilized using the same sterilization method as the primary predicate devices. Subject and reference predicate devices present the same range of sizes and similar overall design.

Overall, the subject devices are equivalent to the predicate devices and reference devices as follows:

The indications for use is identical to those of the primary predicate device, .
. The implant type is identical to those of the primary predicate and reference devices,
. The implant to abutment interface is identical to those of the reference device K161177. K131066 and K101913,
. The implant diameter is similar to those of the primary predicate and reference devices,
The implant length is similar to those of the primary predicate and reference devices, .
. The thread design is similar to those of the reference devices,
. The surface finish is identical to those of the reference devices K161177, K131066 and K101913,
. The material is identical to those of the reference devices K161177, K131066 and K101913.
. Singe use is identical to those of the primary predicate and reference devices,
Sterilization method is identical to those of the primary predicate and reference devices. .

Overall, the subject devices differ from the predicate and reference devices as follow:

lmplant diameter difference :5.8 mm and 6.4 mm diameters. .
Implant length differences: .
- o
- o All the lengths for Ø 5.8mm and Ø 6.4
Thread design difference: The external design with the reduced thread in thickness and . height (alternation of machined and non-machined thread top).

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Anthogyr AXIOM® BL X3 implants and Anthogyr Multi-Unit components for AXIOM® BL

510(k) Summary - K230104

Table 2 – Comparison of subject device versus reference device (Anthogyr Multi-Unit abutments for AXIOM® BL)

	PROPOSED DEVICE	REFERENCE DEVICES
FEATURE	Subject Device - AnthogyrMulti-Unit components forAXIOM®BLK230104	Medentika Multi-unit AbutmentsK191123	Straumann® Screw-RetainedAbutmentsK192401	Straumann® MagellanScrew-Retained AbutmentSystemK133421	Neodent Implant System –GM Narrow ImplantSystemK220251
Intendeduse	Anthogyr Multi-Unit abutmentsare intended to be placed intoAXIOM® BL implants to providesupport for multi-unit prostheticreconstructions such as bridgesand bars. Copings are fixed tothe Multi-Unit abutments inorder to provide support forprosthetic reconstructions suchas bridges and bars.	The Multi-unit Abutments are directlyscrewed into the implant and have auniversal mountingon the face side for various additionalprosthetic parts. The bridge or barelements are produced to fit to theprosthetic parts by which they arescrewed onto the Multi-unitAbutments.	Straumann abutments areintended to be placed intoStraumann dental implants toprovide support for prostheticreconstructions such as crownsand bridges. Copings are fixedto abutments in order to providesupport for prostheticreconstructions such as crowns,bridges and bar-retained over-dentures.	Straumann® dental implantsand abutments are intendedfor use in oral implantationto provide a supportstructure for connectedprosthetic devices.	This product is Indicated forcrown or bridge screwedrestorations on implantsinstalled in maxilla ormandible (NGM microabutment).
	PROPOSED DEVICE	REFERENCE DEVICES
FEATURE	Subject Device - AnthogyrMulti-Unit components forAXIOM®BLK230104	Medentika Multi-unit AbutmentsK191123	Straumann® Screw-RetainedAbutmentsK192401	Straumann® MagellanScrew-Retained AbutmentSystemK133421	Neodent Implant System -GM Narrow ImplantSystemK220251
Indicationsfor use	Anthogyr Multi-Unit prostheticcomponents directly or indirectlyconnected to the endosseousdental implants are indicated foruse to provide support formultiple-unit prostheticreconstructions such as bridgesand bars. The final deviceshave the purpose of restoringchewing function. Temporarycomponents can be used priorto the installation of the finalcomponents to maintain,stabilize and shape the softtissue during the healing phase.The temporary restoration maynot be placed into occlusion.Temporary components have amaximum duration of usage of180 days.The OPMUN0-0 abutments areindicated for maxillary lateraland mandibular central/lateralincisors only.	Multi-unit abutments are indicated foruse with dental implants as asupport for multi-unit screw retainedbridges and bars in the maxilla ormandible of a partially or fullyedentulous patient.Multi-unit Abutments are used for therestoration of the following dentalimplant systems (Implant System /Series / Implant diameter / Platformdiameter):Dentsply® Implants - ASTRA TECHOsseoSpeed® / EVSeries / Diameter3.6, 4.2, 4.8 / Platform 3.6, 4.2, 4.8Nobel Biocare NobelActive -NobelReplace Conical / F-Series /Diameter 3.5, 4.3, 5.0 / Platform NP3.5, RP 4.3/5.0Biomet 3i - Certain / HSeries / Diameter3.25, 4.0 / Platform 3.4, 4.1Straumann - Bone Level / L-Series /Diameter 3.3, 4.1, 4.8 / Platform 3.3,4.1. 4.8Straumann - Soft Tissue Level / N-Series / Diameter 4.1, 4.8 / Platform 4.8,6.5Zimmer Dental Tapered Screw-vent / R-Series / Diameter 3.3, 3.7, 4.1,4.1, 4.7 /Platform 3.5, 4.5	Prosthetic components directlyor indirectly connected to theendosseous dental implant areintended for use as an aid inprosthetic rehabilitations.Temporary components can beused prior to the insertion of thefinal components to maintain,stabilize and shape the softtissue during the healing phase;they are to be placed out ofocclusion. Final abutments maybe placed into occlusion forimplants with sufficient primarystability or for implants that arefully osseointegrated.Temporary Abutments have amaximum duration of usage of180 days.	Magellan™ abutments areindicated to be placed intodental implants to providesupport for prostheticreconstructions such ascrown, bridges and bars.The final processed deviceshave the purpose ofrestoring chewing function.	The Neodent ImplantSystem is intended to besurgically placed in thebone of the upper or lowerjaw to provide support forprosthetic devices, such asartificial teeth, to restorechewing function. It may beused with single stage ortwo-stage procedures, forsingle or multiple unitrestorations, and may beloaded immediately whengood primary stability isachieved and withappropriate occlusalloading.
	PROPOSED DEVICE	REFERENCE DEVICES
FEATURE	Subject Device - AnthogyrMulti-Unit components forAXIOM®BLK230104	Medentika Multi-unit AbutmentsK191123	Straumann® Screw-RetainedAbutmentsK192401	Straumann® MagellanScrew-Retained AbutmentSystemK133421	Neodent Implant System -GM Narrow ImplantSystemK220251
Material	Titanium-6Aluminium-4Vanadium ELI	Ti6Al4V, medical grade 5, conformingASTM F136	Titanium Alloy (Ti-6Al-7Nb)	Titanium Alloy (Ti6Al7Nb)	Titanium alloy ASTM F136(Ti6Al4V-ELI,)
Platformdiameter	Ø 4.8 mm and Ø 4.0 mm	EV series: 3.6 - 4.8 mmF series: 3.5 - 5.0 mmH series: 3.4 - 4.1L series: NC 3.3 - RC 4.1 - 4.8 mmN series: RN 4.8 - WN 6.5 mmR series: 3.5 - 4.5 mm	Ø3.5 and 4.6 mm	Ø 3.5 and 4.6 mm	Ø 3. 5 mm
Gingivalheights	0.75 mm, 1.5 mm, 2.5 mm, 3.5mm and 4.5 mm	GH 0.6 to GH 5.5 mm	1.5, 2.5, 3.5, 4.5 and 5.5 mm	1.0, 2.5 and 4.0 mm	0,8; 1.5, 2.5, and 3.5
Angulation	0°, 18° and 30°	Straight, 17°, 30°	0°, 17°, and 30°	0, 17 and 30°	0°
Abutmentdesign	Straight abutments: one-piece,integrated threadAngulated abutments: two-parts, separate screw.	Straight abutments: one-piece,integrated threadAngulated abutments: two-piece,separate screw.	Straight abutments: one-piece,integrated threadAngulated abutments: two-piece, separate screw.	Straight abutments: one-piece, integrated threadAngulated abutments: two-piece, separate screw.	One-piece, integratedthread

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Anthogyr AXIOM® BL X3 implants and Anthogyr Multi-Unit components for AXIOM® BL

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Anthogyr AXIOM® BL X3 implants and Anthogyr Multi-Unit components for AXIOM® BL

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Anthogyr AXIOM® BL X3 implants and Anthogyr Multi-Unit components for AXIOM® BL

	PROPOSED DEVICE	REFERENCE DEVICES
FEATURE	Subject Device - AnthogyrMulti-Unit components forAXIOM®BLK230104	Medentika Multi-unit AbutmentsK191123	Straumann® Screw-RetainedAbutmentsK192401	Straumann® MagellanScrew-Retained AbutmentSystemK133421	Neodent Implant System -GM Narrow ImplantSystemK220251
MaterialofMulti-Unitbase/coping	Titanium-6Aluminium-4Vanadium ELI	Ti6Al4V, medical grade 5, conformingASTM F136 Gold Cobalt-Chromium	Titanium Alloy (Ti6Al7Nb)CeramicorUse the copings cleared inK133421.	Titanium Alloy (Ti6Al7Nb)Ceramicor	-
Restorationtype	Multi-unit restorations	Multi-unit restorations	Single and Multi (Straight NCGH 1.0 mm (Ø 3.5 mm and Ø4.6mm), are indicated for single-crown restorations in central andlateral incisors, and for multiunitrestorations in incisors topremolars)	Single-unit and multi-unitrestorations	Single-unit and multi-unitrestorations
Reusable	No, single use	No, single use	No, single use	No, single use	No, single use
Sterilizationmethod	Delivered sterile by gammaradiation to an SAL 10-6	Delivered sterile by gamma irradiationto an SAL 10-6	Delivered sterile by gammaIrradiation to an SAL 10-6	Delivered non-sterile, enduser sterilized	delivered sterile viaEthylene Oxide to an SALof 10-6.
	PROPOSED DEVICE	REFERENCE DEVICES
FEATURE	Subject Device - Anthogyr Multi-Unit components for AXIOM® BLK230104	Medentika Multi-unit AbutmentsK191123	Straumann® BLX Implant SystemK173961	Straumann® Screw-RetainedAbutmentsK192401
Indicationsfor use	Anthogyr Multi-Unit prostheticcomponents directly or indirectlyconnected to the endosseous dentalimplants are indicated for use toprovide support for multiple-unitprosthetic reconstructions such asbridges and bars. The final deviceshave the purpose of restoringchewing function. Temporarycomponents can be used prior to theinstallation of the final components tomaintain, stabilize and shape the softtissue during the healing phase. Thetemporary restoration may not beplaced into occlusion.Temporary components have amaximum duration of usage of 180days.The OPMUN0-0 abutments areindicated for maxillary lateral andmandibular central/lateral incisorsonly.	Multi-unit abutments are indicated for usewith dental implants as asupport for multi-unit screw retainedbridges and bars in the maxilla ormandible of a partially or fully edentulouspatient.Multi-unit Abutments are used for therestoration of the following dentalimplant systems (Implant System / Series /Implant diameter / Platform diameter):Dentsply® Implants - ASTRA TECHOsseoSpeed®/ EVSeries / Diameter 3.6,4.2, 4.8 / Platform 3.6, 4.2, 4.8Nobel Biocare NobelActive -NobelReplace Conical / F-Series /Diameter 3.5, 4.3, 5.0 / Platform NP3.5, RP 4.3/5.0Biomet 3i - Certain / HSeries / Diameter3.25, 4.0 / Platform 3.4, 4.1Straumann - Bone Level / L-Series /Diameter 3.3, 4.1, 4.8 / Platform 3.3, 4.1,4.8Straumann - Soft Tissue Level / N-Series /Diameter 4.1, 4.8 / Platform 4.8, 6.5Zimmer Dental Tapered Screw-vent / R-Series / Diameter 3.3, 3.7, 4.1, 4.1, 4.7 /Platform 3.5, 4.5	Prosthetic components directly orindirectly connected to theendosseous dental implant areintended for use as an aid inprosthetic rehabilitations.Temporary components can be usedprior to the insertion of the finalcomponents to maintain, stabilize andshape the soft tissue during thehealing phase; they may not beplaced into occlusion. Finalabutments may be placed intoocclusion when the implant is fullyosseointegrated.BLX Temporary Abutments havea maximum duration of usage of 180days.	Prosthetic components directly orindirectly connected to theendosseous dental implant areintended for use as an aid inprosthetic rehabilitations. Temporarycomponents can be used prior to theinsertion of the final components tomaintain, stabilize and shape the softtissue during the healing phase; theymay not be placed into occlusion.Final abutments may be placed intoocclusion when the implant is fullyosseointegrated.Temporary Abutments have amaximum duration of usage of 180days.
	PROPOSED DEVICE	REFERENCE DEVICES
FEATURE	Subject Device - Anthogyr Multi-Unit components for AXIOM® BLK230104	Medentika Multi-unit AbutmentsK191123	Straumann® BLX Implant SystemK173961	Straumann® Screw-RetainedAbutmentsK192401
Material	Titanium-6Aluminium-4Vanadium ELI	Ti6Al4V, medical grade 5, conformingASTM F136	TAN : Ti-6Al-7Nb	Ti-6Al-7Nb (TAN)
Diameter	Ø 4.8 mm and Ø 4.0 mm	Ø 5.25 mm	Ø 3.8, 4.5, 5.5 and 6 mm	Ø3.5 and 4.6 mm
Durationofuse	180 days	unlimited	180 days	maximum of 180 days
Restoration	Multi unit restorations	Multi unit restorations	unknown	single crowns and bridges
Surfacetreatment	Yellow anodization for MUC100	NA	Anodized signal violet	NA
Chimneydesign	For Straight access Ø 4.8 and Ø 4.0:Wall thickness: 0.9 mmFor Angulated access (angulation =0°):Wall thickness: 0.8 mmFor angulated access (10°, 15°, and25°)Wall thickness: 0.3 mm	Wall thickness: 0.85 mm	Wall thickness: 0.1 mm	For 3.5 NC wall thickness: 0.3 mmFor 4.6 NC and RC wall thickness:0.3 mm
FEATURE	PROPOSED DEVICE	REFERENCE DEVICES
	Subject Device - Anthogyr Multi-Unit components for AXIOM® BLK230104	Medentika Multi-unit AbutmentsK191123	Straumann® BLX Implant SystemK173961	Straumann® Screw-RetainedAbutmentsK192401
Sterilizationmethod	Non sterile - End user sterilization byautoclave	Non sterile - End user sterilization byautoclave	Non sterile - End user sterilization byautoclave	Non-SterileEnd User - Steam Autoclave

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Anthogyr AXIOM® BL X3 implants and Anthogyr Multi-Unit components for AXIOM® BL

510(k) Summary - K230104

Table 3 – Comparison of subject device versus reference device (Anthogyr Multi-Unit temporary copings)

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Anthogyr AXIOM® BL X3 implants and Anthogyr Multi-Unit components for AXIOM® BL

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Anthogyr AXIOM® BL X3 implants and Anthogyr Multi-Unit components for AXIOM® BL

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Anthogyr AXIOM® BL X3 implants and Anthogyr Multi-Unit components for AXIOM® BL

510(k) Summary - K230104

Table 4 – Comparison of subject device versus reference device (Anthogyr Multi-Unit protective caps)

	PROPOSED DEVICE	REFERENCE DEVICES
FEATURE	Subject Device - Anthogyr Multi-Unitcomponents for AXIOM® BLK230104	Medentika Multi-unit AbutmentsK191123	Straumann® Magellan Abutment SystemK133421
Indicationsforuse	Anthogyr Multi-Unit prosthetic componentsdirectly or indirectly connected to theendosseous dental implants are indicated for useto provide support for multiple-unit prostheticreconstructions such as bridges and bars. Thefinal devices have the purpose of restoringchewing function. Temporary components canbe used prior to the installation of the finalcomponents to maintain, stabilize and shape thesoft tissue during the healing phase. Thetemporary restoration may not be placed intoocclusion.Temporary components have a maximumduration of usage of 180 days.The OPMUN0-0 abutments are indicated formaxillary lateral and mandibular central/lateralincisors only.	Multi-unit abutments are indicated for use with dental implantsas asupport for multi-unit screw retained bridges and bars in themaxilla or mandible of a partially or fully edentulous patient.Multi-unit Abutments are used for the restoration of thefollowing denta implant systems (Implant System / Series /Implant diameter / Platform diameter):Dentsply® Implants - ASTRA TECHOsseoSpeed® / EVSeries / Diameter 3.6, 4.2, 4.8 / Platform3.6, 4.2, 4.8Nobel Biocare NobelActive - NobelReplace Conical / F-Series/ Diameter 3.5, 4.3, 5.0 / Platform NP3.5, RP 4.3/5.0Biomet 3i - Certain / HSeries / Diameter 3.25, 4.0 / Platform3.4, 4.1Straumann - Bone Level / L-Series / Diameter 3.3, 4.1, 4.8 /Platform 3.3, 4.1, 4.8Straumann - Soft Tissue Level / N-Series / Diameter 4.1, 4.8 /Platform 4.8, 6.5Zimmer Dental Tapered Screw-vent / R-Series / Diameter 3.3,3.7, 4.1,4.1, 4.7 / Platform 3.5, 4.5	Magellan ™ abutments are indicated to beplaced into dental implants to provide supportfor prosthetic reconstructions such as crown,bridges and bars. The final processed deviceshave the purpose of restoring chewingfunction.
Material	Titanium-6Aluminium-4Vanadium ELI	Titanium Grade 5	polyetheretherketone (PEEK) cap and Ti-6Al-7Nb (TAN) screw
Protectivecapdiameter	Ø 4.8 mm and Ø 4.0 mm	unknown	3.5 mm (NC)4.6 mm (NC and RC)
FEATURE	PROPOSED DEVICE	REFERENCE DEVICES
	Subject Device - Anthogyr Multi-Unitcomponents for AXIOM® BLK230104	Medentika Multi-unit AbutmentsK191123	Straumann® Magellan Abutment SystemK133421
Shape	Columnar design	Columnar design	Columnar design
Duration of use	180 days	180 days	180 days
Protective capsterilizationmethod	Provided sterile by gamma irradiation	Provided nonsterile, sterilized by end user	Non-SterileEnd User – Steam Autoclave

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Anthogyr AXIOM® BL X3 implants and Anthogyr Multi-Unit components for AXIOM® BL

{23}------------------------------------------------

Anthogyr AXIOM® BL X3 implants and Anthogyr Multi-Unit components for AXIOM® BL

510(k) Summary - K230104

The subject devices are substantially equivalent in design, function, sizes and materials to the predicate devices previously cleared in K191123, K192401, K133421, and K220251.

The data included in this submission demonstrate substantial equivalence to the predicate devices. Any differences in the technological characteristics between the subject and predicate devices do not raise different questions of safety or effectiveness.

Overall, the subject devices have the following similarities to the predicate device and reference devices:

. The intended use is identical to those of the reference device, K19240,
. The Indications for use are similar to those of the predicate and reference devices,
. The restoration type is identical to those of the K191123,
. Incorporate a basic design similar to those of the predicate and reference devices,
. The material type (titanium) is similar to those of the predicate and reference devices, and
. The sterilization method is identical to those of K191123 and K192401 for devices delivered in a sterile state. The sterilization method is identical to those of the reference devices for devices delivered non-sterile.

Overall, the subject devices differ from the predicate and reference devices as follow:

OPMUN0-0 Multi-Unit abutment is indicated for multiple-unit restoration only while . K220251 is for both single-unit and multiple-unit restorations.
OPMUN0-0 Multi-Unit abutment is not recommended for placement positions 3, 4, 5, 6, 7, . and 8.
. Anthogyr provide temporary coping with angulated screw channel access (10°, 15° and 25°).

Electromagnetic Compatibility and Electrical Safety

There are no significant changes to the materials and dimensions from the currently cleared predicate devices. Therefore, no new issues of electromagnetic compatibility are raised for the subject devices and they can be considered MR Conditional.

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Anthogyr AXIOM® BL X3 implants and Anthogyr Multi-Unit components for AXIOM® BL

510(k) Summary - K230104

The MR Conditional tests were conducted according to FDA's Guidance "Testing and Labeling Medical Devices for Safety in Magnetic Resonance (MR) Environment".

Performance Testing

Dynamic fatigue tests were conducted according to the FDA guidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and demonstrated the Anthogyr AXIOM® BL X3 implants and Anthogyr Multi-Unit components for AXIOM® BL are equivalent to the predicate and reference devices.

The subject device materials are identical to the predicate and reference device materials, therefore, no new issues regarding biocompatibility were raised. The subject devices have the equivalent nature of body contact, contact duration, material formulation and sterilization methods compared to the primary and reference predicate devices.

For anodized parts, cytotoxicity tests were conducted to the ISO 10993-5 standard "Biological Evaluation of Medical Devices, Part 5: Tests for In Vitro Cytotoxicity" and demonstrated the noncytotoxicity potential of the parts.

The sterilization process for the Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit abutments for AXIOM® BL, and Anthogyr Multi-Unit protective caps are provided sterile via gamma irradiation. A Sterility Assurance Level (SAL) of 10° had been validated according to ISO 11137-1: Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.

The sterilization process as recommended in the labeling for Multi-Unit restorations and prosthetic screws was validated according to standards ISO 17664: Processing of health care products -Information to be provided by the medical device manufacturer for the processing of medical devices and ISO 17665-1: Sterilization of health care products - Moist heat - Part 1: requirements for the development, validation and routine control of a sterilization process for medical devices.

The surface area with and without 3mm of bone resorption, bone to implant contact, and pullout strength were compared to a reference device, K033922, and the results were substantially equivalent.

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Anthogyr AXIOM® BL X3 implants and Anthogyr Multi-Unit components for AXIOM® BL

510(k) Summary - K230104

Conclusion

The documentation submitted in this premarket notification demonstrates the Anthogyr Axiom® BL X3 implants and Anthogyr Multi-Unit components for AXIOM® BL are substantially equivalent to the primary predicate and reference devices.

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.