Predicate Devices

Reference Devices

K161177, K173961, K131066, K101913, K191123, K192401, K133421, K220251, K033922

AI/ML (Artificial Intelligence / Machine Learning)

No
The 510(k) summary describes a dental implant system and associated prosthetic components. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of AI/ML. The performance studies focus on mechanical properties, biocompatibility, and sterilization, which are standard for this type of device.

Therapeutic

Yes
The device, specifically the implant system, is intended to be surgically placed to restore chewing function, which is a therapeutic purpose. Additionally, temporary components are used to maintain, stabilize, and shape soft tissue during the healing phase, also indicating a therapeutic role.

Diagnostic

No

Explanation: The device is an implant system and prosthetic components designed to restore chewing function by supporting artificial teeth and other prosthetic devices. Its intended use is therapeutic and restorative, not diagnostic.

SaMD (Software as a Medical Device)

No

The device description clearly details physical components made of titanium alloy and other materials, intended for surgical implantation and physical support of prosthetic devices. There is no mention of software as the primary or sole component.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the device is for surgical placement in the maxilla or mandible to support prosthetic devices for restoring chewing function. This is a surgical and restorative purpose, not a diagnostic one.
Device Description: The description details dental implants and abutments, which are physical components used in dental surgery and prosthetics.
Lack of Diagnostic Function: There is no mention of the device being used to test samples (blood, tissue, etc.) or to provide information about a patient's health status or condition.
Performance Studies: The performance studies focus on mechanical properties (fatigue), biocompatibility (cytotoxicity), and sterilization, which are relevant to implanted medical devices, not IVDs.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Anthogyr AXIOM® BL X3 implants

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 components for AXIOM® BL

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.

Product codes (comma separated list FDA assigned to the subject device)

DZE, NHA

Device Description

Subject implants

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.

Subject prosthetic components

Anthogyr Multi-Unit abutments for AXIOM® BL
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
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
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.

Anthoqyr Flexibase for Multi-Unit abutments
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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Maxilla or mandible

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K203309

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K161177, K173961, K131066, K101913, K191123, K192401, K133421, K220251, K033922

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

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.

1

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.

2

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

3

Indications for Use

510(k) Number (if known) K230104

Device Name Anthogyr AXIOM® BL X3 Implants

Indications for Use (Describe)

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.

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."

4

Indications for Use

510(k) Number (if known) K230104

Device Name

Anthogyr Multi-Unit components for AXIOM® BL

Indications for Use (Describe)

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.

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."

5

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 NAM
Phone 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-Unit
components 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-Unit
components 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

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

7

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

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

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

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

8

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

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.

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

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.

9

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 | PRIMARY
PREDICATE DEVICE | REFERENCE DEVICES | | | | |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FEATURES | K230104 | K203309 | K161177 | K173961 | K131066 | K101913 | K033922 |
| | Anthogyr AXIOM® BL
X3 implants | NUVO CF Implant
System | AXIOM® PX | Straumann BLX
Implant System | Axiom® REG | Anthogyr Dental
Implant Systems:
AXIOM | Straumann®
Modification to ITI
Dental Implant
System |
| Indications for Use | 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. | 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 dental
implants are intended
for use as artificial root
structures for
replacement of
missing teeth. They
can be used for
stabilization of
removable prostheses
or fixation of single
tooth restorations or
partial dentures.
Anthogyr dental
systems are indicated
for one-stage or two-
stage surgery.It is up
to the practitioner to
decide whether
immediate or delayed
loading is most
appropriate, based on
clinical factors like
good primary stability
and appropriate
occlusal loading. | Straumann® BLX
Implants are suitable
for endosteal
implantation in the
upper and lower jaw
and for the functional
and esthetic oral
rehabilitation of
edentulous and
partially edentulous
patients. BLX Implants
can be placed with
immediate function on
single-tooth
applications when
good primary stability
is achieved and with
appropriate occlusal
loading to restore
chewing function. The
prosthetic restorations
are connected to the
implants through the
corresponding
abutment components. | Anthogyr AXIOM® REG
implants are intended
for use as artificial root
structures for
replacement of missing
teeth. They can be used
for stabilization of
removable prostheses
or fixation of single tooth
restorations or partial
dentures.
The Axiom dental
system is indicated for
one-stage or two-stage
surgery.
It is up to the
practitioner to decide
whether immediate or
delayed loading is most
appropriate, based on
clinical factors like good
primary stability and
appropriate occlusal
loading.
Prefabricated
components are
intended for use as
accessories to dental
implants to support
implant-supported
restorations. | Both Dental Implant
Systems are intended
for use in partially or
fully edentulous
mandibles and
maxillae, in support of
single or multiple-unit
restorations including;
cement retained,
screw retained or
overdenture
restorations, and
terminal or
intermediate abutment
support for fixed
bridgework. | ITI implants are
intended for surgical
placement in the
maxillary and/or
mandibular arches to
provide support for
prosthetic restoration
in edentulous or
partially edentulous
patients. ITI Dental
Implants are for single-
stage or two-stage
surgery.
ITI Dental Implants are
intended for immediate
placement and
function on single-
tooth and/or multiple
tooth applications
when good primary
stability is achieved,
with appropriate
occlusal loading, in
order to restore
chewing function.
Multiple tooth
applications may be
rigidly splinted. In the
case of edentulous
patients, four or more
implants must be
used. |
| | SUBJECT DEVICE | PRIMARY
PREDICATE DEVICE | REFERENCE DEVICES | | | | |
| | K230104 | K203309 | K161177 | K173961 | K131066 | K101913 | K033922 |
| FEATURES | Anthogyr AXIOM® BL
X3 implants | NUVO CF Implant
System | AXIOM® PX | Straumann BLX
Implant System | Axiom® REG | Anthogyr Dental
Implant Systems:
AXIOM | Straumann®
Modification to ITI
Dental Implant
System |
| Implant type | Bone Level | Bone Level | Bone Level | Bone Level | Bone Level | Bone Level | Tissue Level |
| Implant to Abutment
interface | 2.7 mm diameter
conical Morse taper
connection with tri-lobe | Internal Hex | 2.7 mm diameter
conical Morse taper
connection with tri-lobe | BLX (with conical
fitting) | 2,7 mm diameter
conical Morse taper
connection with tri-lobe | 2,7 mm diameter
conical Morse taper
connection with tri-lobe | Straumann® synOcta®
connection |
| Implant Diameter | Ø 3.4 mm, 4.0 mm, 4.6
mm, 5.2 mm, 5.8mm
and 6.4 mm | Ø 3.5 mm, 3.75 mm,
4.0, 4.3 mm and 5.0
mm | Ø 3.4 mm, 4.0 mm, 4.6
mm, and 5.2 mm | Ø 4.5 mm, 5.5 mm, 6.5
mm | Ø 3.4 mm and 4.0 mm | Ø 3.4 mm, 4.0 mm, 4.6
mm and 5.2 mm | Ø 3.3mm
Ø 4.1mm
Ø 4.8mm |
| Implant Length | Ø 3.4 mm : 8, 10, 12,
14, 16 and 18 mm
4.0 mm : 6.5, 8, 10,
12, 14, 16 and 18 mm
4.6 mm : 6.5, 8, 10, 12
and 14 mm
5.2 mm : 6.5, 8, 10
and 12 mm
5.8mm : 6.5, 8, 10 and
12 mm
6.4 mm : 6.5, 8, 10,12
mm | 3.5 mm: 8, 10, 11.5,
13, 16 & 18 mm
3.75 mm: 8, 10, 11.5,
13, 16 & 18 mm
4.0 mm: 7, 8, 10,
11.5, 13, 16 & 18 mm
4.3 mm: 7. 8, 10,
11.5, 13, 16 & 18 mm
5.0 mm: 7, 8, 10, 11.5,
13 & 16 mm | 3.4 mm: 8, 10, 12, 14,
16 and 18 mm
4.0 mm : 8, 10, 12, 14,
16 and 18 mm
4.6 mm : 6.5, 8, 10, 12
and 14 mm
5.2 mm : 6.5, 8, 10, 12
mm | Ø 4.5 mm : 6, 8, 10,
12, 14, 16 and 18 mm
Ø 5.5 mm : 6, 8, 10,
and 12mm
Ø 6.5 mm : 6, 8, 10,
and 12mm | Ø 3.4 mm : 16 and 18
mm
Ø 4.0 mm: 16 and 18
mm | Ø 3.4 mm : 8, 10, 12
and 14 mm
Ø 4.0 mm : 6, 8, 10, 12
and 14 mm
Ø 4.6 mm : 6, 8, 10, 12
and 14 mm
Ø 5.2 mm : 6, 8, 10, 12
and 14 mm | Ø 3.3mm : 8, 10, 12
and 14 mm
Ø 4.1mm : 6, 8, 10, 12
and 14 mm
Ø 4.8mm : 6, 8, 10, 12
and 14 mm |
| Thread Design | Tapered body | Apically Tapered, Dual
Helix | Tapered body | Tapered body | Tapered body | Tapered body | Tapered body |
| Surface finish | Sand blasted and acid
etched (BCP) | Sand blasted and acid
etched (Neoporos) | Sand blasted and acid
etched (BCP) | Hydrophilic SLActive® | Sand blasted and acid
etched (BCP) | Sand blasted and acid
etched (BCP) | SLA® - that is large-
grit sandblasted and
acid-etched |
| Material | Titanium-6Aluminum-
4Vanadium ELI (grade
23) | Commercially Pure
Titanium (Grade 4) | Titanium-6Aluminum-
4Vanadium ELI (grade
23) | Titanium-13 Zirconium
alloy (Roxolid®) | Titanium-6Aluminum-
4Vanadium ELI (grade
23) | Titanium-6Aluminum-
4Vanadium ELI (grade
23) | 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 | PRIMARY
PREDICATE DEVICE | REFERENCE DEVICES | | | | |
|----------------------|------------------------------------------|------------------------------------------|------------------------------------------|------------------------------------------|------------------------------------------|----------------------------------------------|---------------------------------------------------------------|
| | K230104 | K203309 | K161177 | K173961 | K131066 | K101913 | K033922 |
| | Anthogyr AXIOM® BL
X3 implants | NUVO CF Implant
System | AXIOM® PX | Straumann BLX
Implant System | Axiom® REG | Anthogyr Dental
Implant Systems:
AXIOM | Straumann®
Modification to ITI
Dental Implant
System |
| Sterilization Method | Gamma Irradiation to
an SAL of 1x10-6 | Gamma Irradiation to
an SAL of 1x10-6 | Gamma Irradiation to
an SAL of 1x10-6 | Gamma Irradiation to
an SAL of 1x10-6 | Gamma Irradiation to
an SAL of 1x10-6 | Gamma Irradiation to
an SAL of 1x10-6 | Gamma Irradiation to
an 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 - Anthogyr
Multi-Unit components for
AXIOM®BL
K230104	Medentika Multi-unit Abutments
K191123	Straumann® Screw-Retained
Abutments
K192401	Straumann® Magellan
Screw-Retained Abutment
System
K133421	Neodent Implant System –
GM Narrow Implant
System
K220251
Intended
use	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.	The Multi-unit Abutments are directly
screwed into the implant and have a
universal mounting
on the face side for various additional
prosthetic parts. The bridge or bar
elements are produced to fit to the
prosthetic parts by which they are
screwed onto the Multi-unit
Abutments.	Straumann abutments are
intended to be placed into
Straumann dental implants to
provide support for prosthetic
reconstructions such as crowns
and bridges. Copings are fixed
to abutments in order to provide
support for prosthetic
reconstructions such as crowns,
bridges and bar-retained over-
dentures.	Straumann® dental implants
and abutments are intended
for use in oral implantation
to provide a support
structure for connected
prosthetic devices.	This product is Indicated for
crown or bridge screwed
restorations on implants
installed in maxilla or
mandible (NGM micro
abutment).
	PROPOSED DEVICE	REFERENCE DEVICES
FEATURE	Subject Device - Anthogyr
Multi-Unit components for
AXIOM®BL
K230104	Medentika Multi-unit Abutments
K191123	Straumann® Screw-Retained
Abutments
K192401	Straumann® Magellan
Screw-Retained Abutment
System
K133421	Neodent Implant System -
GM Narrow Implant
System
K220251
Indications
for use	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 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.	Multi-unit abutments are indicated for
use with dental implants as a
support for multi-unit screw retained
bridges and bars in the maxilla or
mandible of a partially or fully
edentulous patient.
Multi-unit Abutments are used for the
restoration of the following dental
implant systems (Implant System /
Series / Implant diameter / Platform
diameter):
Dentsply® Implants - ASTRA TECH
OsseoSpeed® / EVSeries / Diameter
3.6, 4.2, 4.8 / Platform 3.6, 4.2, 4.8
Nobel Biocare NobelActive -
NobelReplace Conical / F-Series /
Diameter 3.5, 4.3, 5.0 / Platform NP
3.5, RP 4.3/5.0
Biomet 3i - Certain / HSeries / Diameter
3.25, 4.0 / Platform 3.4, 4.1
Straumann - Bone Level / L-Series /
Diameter 3.3, 4.1, 4.8 / Platform 3.3,
4.1. 4.8
Straumann - Soft Tissue Level / N-
Series / Diameter 4.1, 4.8 / Platform 4.8,
6.5
Zimmer 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
or indirectly connected to the
endosseous dental implant are
intended for use as an aid in
prosthetic rehabilitations.
Temporary components can be
used prior to the insertion of the
final components to maintain,
stabilize and shape the soft
tissue during the healing phase;
they are to be placed out of
occlusion. Final abutments may
be placed into occlusion for
implants with sufficient primary
stability or for implants that are
fully osseointegrated.
Temporary Abutments have a
maximum duration of usage of
180 days.	Magellan™ abutments are
indicated to be placed into
dental implants to provide
support for prosthetic
reconstructions such as
crown, bridges and bars.
The final processed devices
have the purpose of
restoring chewing function.	The Neodent Implant
System is intended to be
surgically placed in the
bone of the upper or lower
jaw to provide support for
prosthetic devices, such as
artificial teeth, 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.
	PROPOSED DEVICE	REFERENCE DEVICES
FEATURE	Subject Device - Anthogyr
Multi-Unit components for
AXIOM®BL
K230104	Medentika Multi-unit Abutments
K191123	Straumann® Screw-Retained
Abutments
K192401	Straumann® Magellan
Screw-Retained Abutment
System
K133421	Neodent Implant System -
GM Narrow Implant
System
K220251
Material	Titanium-6Aluminium-
4Vanadium ELI	Ti6Al4V, medical grade 5, conforming
ASTM F136	Titanium Alloy (Ti-6Al-7Nb)	Titanium Alloy (Ti6Al7Nb)	Titanium alloy ASTM F136
(Ti6Al4V-ELI,)
Platform
diameter	Ø 4.8 mm and Ø 4.0 mm	EV series: 3.6 - 4.8 mm
F series: 3.5 - 5.0 mm
H series: 3.4 - 4.1
L series: NC 3.3 - RC 4.1 - 4.8 mm
N series: RN 4.8 - WN 6.5 mm
R series: 3.5 - 4.5 mm	Ø3.5 and 4.6 mm	Ø 3.5 and 4.6 mm	Ø 3. 5 mm
Gingival
heights	0.75 mm, 1.5 mm, 2.5 mm, 3.5
mm 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°
Abutment
design	Straight abutments: one-piece,
integrated thread
Angulated abutments: two-
parts, separate screw.	Straight abutments: one-piece,
integrated thread
Angulated abutments: two-piece,
separate screw.	Straight abutments: one-piece,
integrated thread
Angulated abutments: two-
piece, separate screw.	Straight abutments: one-
piece, integrated thread
Angulated abutments: two-
piece, separate screw.	One-piece, integrated
thread

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

16

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

17

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

	PROPOSED DEVICE	REFERENCE DEVICES
FEATURE	Subject Device - Anthogyr
Multi-Unit components for
AXIOM®BL
K230104	Medentika Multi-unit Abutments
K191123	Straumann® Screw-Retained
Abutments
K192401	Straumann® Magellan
Screw-Retained Abutment
System
K133421	Neodent Implant System -
GM Narrow Implant
System
K220251
Material
of
Multi-Unit
base/coping	Titanium-6Aluminium-
4Vanadium ELI	Ti6Al4V, medical grade 5, conforming
ASTM F136 Gold Cobalt-Chromium	Titanium Alloy (Ti6Al7Nb)
Ceramicor
Use the copings cleared in
K133421.	Titanium Alloy (Ti6Al7Nb)
Ceramicor	-
Restoration
type	Multi-unit restorations	Multi-unit restorations	Single and Multi (Straight NC
GH 1.0 mm (Ø 3.5 mm and Ø4.6
mm), are indicated for single-
crown restorations in central and
lateral incisors, and for multiunit
restorations in incisors to
premolars)	Single-unit and multi-unit
restorations	Single-unit and multi-unit
restorations
Reusable	No, single use	No, single use	No, single use	No, single use	No, single use
Sterilization
method	Delivered sterile by gamma
radiation to an SAL 10-6	Delivered sterile by gamma irradiation
to an SAL 10-6	Delivered sterile by gamma
Irradiation to an SAL 10-6	Delivered non-sterile, end
user sterilized	delivered sterile via
Ethylene Oxide to an SAL
of 10-6.
	PROPOSED DEVICE	REFERENCE DEVICES
FEATURE	Subject Device - Anthogyr Multi-
Unit components for AXIOM® BL
K230104	Medentika Multi-unit Abutments
K191123	Straumann® BLX Implant System
K173961	Straumann® Screw-Retained
Abutments
K192401
Indications
for use	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
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.	Multi-unit abutments are indicated for use
with dental implants as a
support for multi-unit screw retained
bridges and bars in the maxilla or
mandible of a partially or fully edentulous
patient.
Multi-unit Abutments are used for the
restoration of the following dental
implant systems (Implant System / Series /
Implant diameter / Platform diameter):
Dentsply® Implants - ASTRA TECH
OsseoSpeed®/ EVSeries / Diameter 3.6,
4.2, 4.8 / Platform 3.6, 4.2, 4.8
Nobel Biocare NobelActive -
NobelReplace Conical / F-Series /
Diameter 3.5, 4.3, 5.0 / Platform NP
3.5, RP 4.3/5.0
Biomet 3i - Certain / HSeries / Diameter
3.25, 4.0 / Platform 3.4, 4.1
Straumann - Bone Level / L-Series /
Diameter 3.3, 4.1, 4.8 / Platform 3.3, 4.1,
4.8
Straumann - Soft Tissue Level / N-Series /
Diameter 4.1, 4.8 / Platform 4.8, 6.5
Zimmer 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 or
indirectly connected to the
endosseous dental implant are
intended for use as an aid in
prosthetic rehabilitations.
Temporary components can be used
prior to the insertion of the final
components to maintain, stabilize and
shape the soft tissue during the
healing phase; they may not be
placed into occlusion. Final
abutments may be placed into
occlusion when the implant is fully
osseointegrated.
BLX Temporary Abutments have
a maximum duration of usage of 180
days.	Prosthetic components directly or
indirectly connected to the
endosseous dental implant are
intended for use as an aid in
prosthetic rehabilitations. Temporary
components can be used prior to the
insertion of the final components to
maintain, stabilize and shape the soft
tissue during the healing phase; they
may not be placed into occlusion.
Final abutments may be placed into
occlusion when the implant is fully
osseointegrated.
Temporary Abutments have a
maximum duration of usage of 180
days.
	PROPOSED DEVICE	REFERENCE DEVICES
FEATURE	Subject Device - Anthogyr Multi-
Unit components for AXIOM® BL
K230104	Medentika Multi-unit Abutments
K191123	Straumann® BLX Implant System
K173961	Straumann® Screw-Retained
Abutments
K192401
Material	Titanium-6Aluminium-4Vanadium ELI	Ti6Al4V, medical grade 5, conforming
ASTM 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
Duration
of
use	180 days	unlimited	180 days	maximum of 180 days
Restoration	Multi unit restorations	Multi unit restorations	unknown	single crowns and bridges
Surface
treatment	Yellow anodization for MUC100	NA	Anodized signal violet	NA
Chimney
design	For Straight access Ø 4.8 and Ø 4.0:
Wall thickness: 0.9 mm

For Angulated access (angulation =
0°):Wall thickness: 0.8 mm

For angulated access (10°, 15°, and
25°)
Wall thickness: 0.3 mm | Wall thickness: 0.85 mm | Wall thickness: 0.1 mm | For 3.5 NC wall thickness: 0.3 mm

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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-Unit
components for AXIOM® BL
K230104	Medentika Multi-unit Abutments
K191123	Straumann® Magellan Abutment System
K133421
Indications
for
use	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 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. | Multi-unit abutments are indicated for use with dental implants
as a
support for multi-unit screw retained bridges and bars in the
maxilla or mandible of a partially or fully edentulous patient.
Multi-unit Abutments are used for the restoration of the
following denta implant systems (Implant System / Series /
Implant diameter / Platform diameter):
Dentsply® Implants - ASTRA TECH
OsseoSpeed® / EVSeries / Diameter 3.6, 4.2, 4.8 / Platform
3.6, 4.2, 4.8
Nobel Biocare NobelActive - NobelReplace Conical / F-Series
/ Diameter 3.5, 4.3, 5.0 / Platform NP
3.5, RP 4.3/5.0
Biomet 3i - Certain / HSeries / Diameter 3.25, 4.0 / Platform
3.4, 4.1
Straumann - Bone Level / L-Series / Diameter 3.3, 4.1, 4.8 /
Platform 3.3, 4.1, 4.8
Straumann - Soft Tissue Level / N-Series / Diameter 4.1, 4.8 /
Platform 4.8, 6.5
Zimmer 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 be
placed into dental implants to provide support
for prosthetic reconstructions such as crown,
bridges and bars. The final processed devices
have the purpose of restoring chewing
function. |
| Material | Titanium-6Aluminium-4Vanadium ELI | Titanium Grade 5 | polyetheretherketone (PEEK) cap and Ti-6Al-
7Nb (TAN) screw |
| Protective
cap
diameter | 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-Unit
components for AXIOM® BL
K230104 | Medentika Multi-unit Abutments
K191123 | Straumann® Magellan Abutment System
K133421 |
| Shape | Columnar design | Columnar design | Columnar design |
| Duration of use | 180 days | 180 days | 180 days |
| Protective cap
sterilization
method | Provided sterile by gamma irradiation | Provided nonsterile, sterilized by end user | Non-Sterile
End User – Steam Autoclave |

22

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.

24

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.