K Number

Device Name

Anthogyr FlexiBase® titanium bases for Axiom® BL

Manufacturer

Anthogyr

Date Cleared

2024-01-04

(265 days)

Product Code

NHA

Regulation Number

872.3630

Intended Use

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

Device Description

Anthogyr FlexiBase® titanium bases for Axiom® BL are intended to be placed into Anthogyr dental implants to provide support for single-unit restorations. The second component of the two-piece abutment (coping or crown) must be cemented onto the titanium component of the FlexiBase® abutment to constitute the final two-piece abutment design, which is then screwed onto the implant. The bottom portion of the FlexiBase® are made from Titanium alloy. They are provided in several dimensions, there is one chimney height, and two platform diameters of 4.0 mm and 5.0 mm, and for each of the platform diameters there are three gingival heights of 1.5 mm, 2.5 mm and 3.5 mm. Anthogyr FlexiBase® titanium bases for Axiom® BL are very similar to the primary predicate device Medentika TiBase CAD/CAM Abutments cleared in K150203. The FlexiBase® are fixed in the implant by means of a prosthetic screw which is manufactured in titanium alloy and DLC coated identical to K161177. The FlexiBase® abutments are two-piece abutments used as a base when fabricating a CAD/CAM customized restoration. The design and milling of the customized restoration must be made using the Straumann CARES® Visual software. The FlexiBase® is a two-piece abutment ultimately composed by three components: - . FlexiBase® abutment titanium component - Top-half component (coping and/or crown) . - . Prosthetic screw The FlexiBase® abutments will be marketed: - through a validated Straumann Centralized milling center, in this case all digitally . designed copings and/or crowns are intended to be manufactured at a validated Straumann milling center (Straumann CARES® System).

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K150203

Reference Devices

K222836, K190082, K173961, K170354

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a physical dental abutment and its manufacturing process, with no mention of AI or ML. The CAD/CAM software mentioned is for design and milling, not AI/ML analysis.

Therapeutic

No.

The device is a component of a dental prosthetic restoration system, specifically a titanium base for dental abutments. Its function is to support a prosthetic restoration and it does not directly achieve a therapeutic effect.

Diagnostic

This device is a dental abutment, a prosthetic component. It is used to support single-unit customized prosthetic restorations and is not intended for the diagnosis of any condition.

SaMD (Software as a Medical Device)

The device description clearly states that the device is a physical titanium base and associated components used in dental implants. While it mentions the use of CAD/CAM software for designing the restoration, the device itself is a hardware 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 a "support for single-unit customized prosthetic restorations" and is used in conjunction with dental implants. This describes a device used in vivo (within the body) for structural support in dental procedures.
Device Description: The description details the physical components (titanium bases, prosthetic screw, coping/crown) and how they are assembled and used in a dental implant system. This aligns with a medical device used for treatment or restoration within the body.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. The device itself is a physical component implanted or attached to an implant.

Therefore, the Anthogyr FlexiBase® titanium bases for Axiom® BL are a medical device, specifically a dental abutment, and not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

NHA

Device Description

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

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

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

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

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

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

The FlexiBase® abutments will be marketed:

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

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

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

Biocompatibility Testing: Biological assessment has been performed according to ISO 10993-1 "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" and to the FDA Guidance document "Use of International Standard ISO 10993- 1, 'Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process', Guidance for Industry and Food and Drug Administration Staff, Document issued on: June 16, 2016" for each of the subject devices. Cytotoxicity testing was performed on the subject devices per ISO 10993-5. The subject devices are equivalent in material to the primary predicate and reference devices, therefore, no new issues regarding biocompatibility were raised.

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

Performance Testing - Bench: Dynamic fatique testing was conducted according to the FDA quidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and ISO 14801 "Dentistry — Implants — Dynamic loading test for endosseous dental implants" and demonstrated the subject devices are equivalent to the primary predicate and reference devices. The test was conducted in saline (2 Hz and 37 °C) at 2 million cycles covering permanent restoration of the Anthogyr FlexiBase® titanium bases for Axiom® BL without failure. Test was conducted in saline (2 Hz and 37 °C at 200,000 cycles covering the temporary restoration of the Anthogyr FlexiBase® titanium bases for Axiom® BL without failure.

Key Metrics

Not Found

Predicate Device(s)

K150203 Medentika CAD/CAM Abutments

Reference Device(s)

K222836 Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia Discs, K190082 Straumann BLX Variobase Abutment, K173961 – Straumann BLX Implant System, K170354 Straumann® Variobase® Abutments

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 872.3630 Endosseous dental implant abutment.

(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)

Summary

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

January 4, 2024

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

Re: K231072

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

Dear Jennifer Jackson:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

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

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Andrew I. Steen -S

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

Enclosure

Indications for Use

510(k) Number (if known) K231072

Device Name

Anthogyr FlexiBase® titanium bases for Axiom® BL

Indications for Use (Describe)

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

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

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

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K231072 - Anthogyr FlexiBase® titanium bases for Axiom® BL

510(k) Summary

Submitter's Contact Information

| Submitter: | Straumann USA, LLC (on behalf of Anthogyr)
60 Minuteman Road
Andover, MA 01810
Registration No.: 1222315 Owner/Operator No.: 9005052 |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| | On the behalf of: |
| | Anthogyr
2 237 Avenue André Lasquin
74700 Sallanches, France |
| Contact Person: | Jennifer M. Jackson, MS, RAC
Sr. Director, Regulatory Affairs and Quality
Phone Number: +1 978 747-2509
Fax Number: +1 978 747-0023 |
| Prepared By &
Alternate Contact: | Estelle SALLE
Regulatory Affairs Project Manager
Anthogyr
Phone number: +33 (0)4 50 58 02 37 |
| Date of Submission: | January 4, 2024 |

Name of the Device

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

K231072 - Anthogyr FlexiBase® titanium bases for Axiom® BL

Predicate Device(s)

Primary Predicate:

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

Compatible Dental Implants:

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

Device Description

Anthogyr FlexiBase® titanium bases for Axiom® BL

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

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

K231072 - Anthogyr FlexiBase® titanium bases for Axiom® BL

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

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

The FlexiBase® abutments will be marketed:

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

Prosthetic Restoration Design and Materials

The following is an overview of the possible coping materials:

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

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

Anthogyr prosthetic screw

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

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

Intended Use

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

K231072 - Anthogyr FlexiBase® titanium bases for Axiom® BL

Indications for Use

Technological Characteristics

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

K231072 - Anthogyr FlexiBase® titanium bases for Axiom® BL

	PROPOSED DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE DEVICE
FEATURE	Subject Device - Anthogyr
FlexiBase® titanium bases
for Axiom® BL	Medentika CAD/CAM Abutments
K150203	Straumann BLX Variobase
Abutment
K190082	Straumann BLX Implant
System
K173961	Straumann® Variobase®
Abutments
K170354
Indication for
use	Anthogyr FlexiBase®
titanium bases for Axiom®
BL are indicated for use as
a support for single-unit
customized prosthetic
restorations. All digitally
designed copings and / or
crowns for use with the
Anthogyr Flexibase®
titanium bases for Axiom®
BL are intended to be sent
to Straumann for
manufacturing by a
validated milling center
(Straumann CARES
System).	Medentika CAD/CAM abutments are
intended for use with dental implants
as a support for single or multiple
tooth prostheses in the maxilla or
mandible of a partially or fully
edentulous patient.
Abutments are compatible with the
following implant systems:
E-Series: Nobel Biocare Replace™
Select 3.5, 4.3, 5.0, 6.0 F-Series: Nobel Biocare
NobelActive™ 3.5, 4.3, 5.0 H-Series: Biomet 3i Osseotite Certain
3.25, 4.0, 5.0 I-Series: Biomet 3i Osseotite 3.25,
3.75, 4.0, 5.0 K-Series: Nobel Biocare Brånemark
3.3, 3.75, 4.0, 5.0 L-Series: Straumann Bone Level 3.3,
4.1, 4.8 N-Series: Straumann Standard 3.3,
4.1, 4.8 R-Series: Zimmer Tapered Screw-
Vent 3.3, 3.7, 4.1, 4.7, 6.0 S-Series: Astra Tech OsseoSpeed
3.5/4.0, 4.5/5.0 T-Series: Dentsply Friadent
Frialit/XiVE 3.4, 3.8, 4.5, 5.5 Y-Series: Dentsply Friadent Ankylos
3.5, 4.5, 5.5, 7.0 Medentika TiBase is intended for use
with the Straumann® CARES® System.	Straumann® Variobase®
prosthetic components directly
or indirectly connected to the
endosseous dental implant
are intended for use as an aid
in prosthetic rehabilitations.
The prosthetic restoration
(crowns) can be cemented
onto the Straumann®
Variobase®
prosthetic components. A
temporary restoration 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 be
placed out of occlusion. Final
abutments and restorations
may be placed into occlusion
when the implant is fully
osseointegrated. All digitally
designed copings and/or
crowns for use with the
Straumann® Variobase®
Abutment system are
intended to be sent to
Straumann for manufacture at
a validated milling center.	Straumann® Variobase®
prosthetic components directly
or indirectly connected to the
endosseous dental implant are
intended for use as an aid in
prosthetic rehabilitations.
The prosthetic restoration
(crowns) can be cemented onto
the Straumann® Variobase®
prosthetic components. A
temporary restoration 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 be placed out of
occlusion. Final abutments and
restorations may be placed into
occlusion when the implant is
fully osseointegrated. All digitally
designed copings and/or crowns
for use with the Straumann®
Variobase® Abutment system
are intended to be sent to
Straumann for manufacture at a
validated milling center.	The Straumann®
Variobase™ Abutment is
a titanium base placed
onto Straumann dental
implants to provide
support for customized
prosthetic restorations.
Straumann® Variobase™
Abutments are indicated
for screw-retained single
tooth or cement retained
single tooth and bridge
restorations.
Material	Titanium: 3.7165.1-Ti-6Al-
4VELI	Titanium Alloy: Ti-6Al-4V ELI	Ti-6Al-7Nb	Ti-6Al-7Nb	Titanium-Aluminum-
Niobium alloy (Ti-6Al-
7Nb)
Abutment
diameters	Ø4 mm and Ø5 mm	Ø 3.0 - 7.0 mm	Ø 3.8 to 5.5 mm	Ø 3.8, 4.5, and 5.5 mm	Ø 3.8 - 7.0 mm
	PROPOSED DEVICE
PRIMARY PREDICATE DEVICE
REFERENCE DEVICE
FEATURE	Subject Device - Anthogyr
FlexiBase® titanium bases
for Axiom® BL	Medentika CAD/CAM Abutments
K150203	Straumann BLX Variobase
Abutment
K190082	Straumann BLX Implant
System
K173961	Straumann® Variobase®
Abutments
K170354
Titanium
component
Gingival
height(s)*	1.5, 2.5 and 3.5 mm*	-	0.75 - 3.5 mm*	0.75 - 2.5 mm*	-
Titanium
component
chimney
height(s)*	3.5 mm*	4 mm - 5.5 mm*	4 mm and 6 mm*	-	3.5 – 4.5 mm*
Minimum
Abutment
Post Height
above the
gingival
margin of the
final design	4 mm	4 mm	4 mm	4 mm	4 mm
Restoration
type	Single-unit	Single or multiple tooth
prostheses	Screw-retained single-unit, or
Cement-retained single or
multi-unit	-	-
Top-half
materials	n!ce CoCr
n!ce Zr LT
n!ce Zr HT
n!ce Zr XT
n!ce® glass ceramic
n!ce PMMA (temporary)	Zirconia	coron®
zerion® LT
zerion® ML and UTML	IPS e.max CAD
Polycon® ae	Coron®
Zerion®
IPS e.max CAD
n!ce
Polycon® ae
Abutment
angulation	Up to 30°	Up to 30°	Up to 30°	Up to 30°	Up to 30°
Prosthesis
attachment	Screw-retained	Cement retained	Cement retained	Screw-retained or cement
retained	Screw-retained or
cement retained
Cement used
in device
performance
testing	PANAVIA V5 by KURARAY
DENTAL, cleared by FDA
under K150704	Multilink Hybrid Abutment
Cement by Ivoclar (K130436).	Kuraray Panavia V5	Kuraray Panavia V5	-
	PROPOSED DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE DEVICE
FEATURE	Subject Device - Anthogyr
FlexiBase® titanium bases
for Axiom® BL	Medentika CAD/CAM Abutments
K150203	Straumann BLX Variobase
Abutment
K190082	Straumann BLX Implant
System
K173961	Straumann® Variobase®
Abutments
K170354
Cement to fix
patient-
specific
coping
according to
IFU	PANAVIA V5 by KURARAY
DENTAL, cleared by FDA
under K150704	Multilink Hybrid Abutment
Cement by Ivoclar (K130436).	Kuraray Panavia V5	Kuraray Panavia V5	-
Geometry
definition
workflow	Straumann CARES system
validated centralized milling
center under manufacturing
control	Straumann CARES system
validated centralized milling
center under manufacturing
control	Wax-up or Straumann
CARES® Visual, Dental
Wings software using the
Straumann CARES Visual
Plug-In and 3Shape	Wax-up or Straumann CARES®
Visual, Dental Wings software
using the Straumann CARES
Visual Plug-In and 3Shape	Wax-up or Straumann
CARES® Visual, Dental
Wings software using the
Straumann CARES
Visual Plug-In and
3Shape
Manufacturing
workflow	Straumann Milling Center	Straumann Milling Center	Straumann Milling Center	Straumann Milling Center	Traditional casting or
pressing or Straumann
Milling Center
Reusable	No, single-use	No, single-use	No, single-use	No, single-use	No, single-use
Sterility	Non sterile - End user
sterilization by autoclave	Non sterile - End user
sterilization by autoclave	Non sterile - End user
sterilization by autoclave	Non sterile - End user
sterilization by autoclave	Non sterile - End user
sterilization by autoclave

K231072 - Anthogyr FlexiBase® titanium bases for Axiom® BL

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

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

System – Validated centralized milling center)

Anthogyr FlexiBase® titanium bases for Axiom® BL

Appendix 8

Performance Testing 1.1 -

Sterilization Validation and Shelf-life

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

Biocompatibility Testing

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

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

Electromagnetic Compatibility

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

Performance Testing - Bench

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

Anthogyr FlexiBase® titanium bases for Axiom® BL

Appendix 9

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

Conclusion

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