Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the mechanical properties, biocompatibility, and sterilization of dental abutments, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.

Therapeutic

Yes
The device is a medical device intended to provide a support structure for oral rehabilitation, which is a therapeutic purpose.

Diagnostic

No

Explanation: The device, implants, provide a support structure for oral rehabilitation. There is no indication that they are used to diagnose a medical condition.

SaMD (Software as a Medical Device)

No

The device description clearly details physical components made of materials like TAN and Ceramicor®, intended for surgical implantation. 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 that the abutments are placed into dental implants to provide support for prosthetic rehabilitations (crowns, bridges, etc.). This is a surgical and prosthetic device, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
Device Description: The description details the materials, design, and how the abutments are secured to the implant. This aligns with a medical device used for implantation and prosthetic support.
Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information.

The device is a dental implant abutment, which is a type of medical device used in oral surgery and prosthetics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

TLX SRAs

Straumann® abutments are indicated to be placed into Straumann® dental implants to provide a support structure for the functional and esthetic oral rehabilitation of edentulous or partially edentulous patients with crowns, bridges, or full-arch prostheses.

TLX Gold Abutments

Straumann® abutments are indicated to be placed into Straumann® dental implants to provide a support structure for the functional and esthetic oral rehabilitation of edentulous or partially edentulous patients with crowns, bridges, or full-arch prostheses.

Copings are indirectly connected to the endosseous dental implant and are indicated for use as an aid in prosthetic rehabilitations.

Product codes

NHA

Device Description

TLX SRAs

Straumann® TLX SRAs are intended to be placed on TLX Straumann dental implants to provide support for screw-retained single or multi-unit restorations. They are identical in design to the reference devices BLX SRAs cleared as per K181703, except for the laser marking and the anodization. The TLX SRAs have no anodization, but additional laser marking at the connection. The TLX SRAs are provided sterile by gamma radiation. The TLX SRAs are made of TAN (Ti-6Al-7Nb) and are available in angulations of 17° and 30°. The TLX SRAs are secured in the implant through a basal screw made of TAN. The SRAs are provided with a transfer piece (Pin).

TLX Gold Abutments

Straumann TLX Gold Abutments consist of a Ceramicor® alloy base, which is fixed to the implant by means of a basal screw made of Ti-6AI-7Nb, Titanium Aluminum Niobium (TAN). A modelling aid made of POM-C is attached onto the abutment by friction fit when delivered in the package. There are two versions of TLX Gold Abutments: one is for single crown restoration, and the other is for multiunit restoration such as bar or bridge. The TLX Gold Abutments for crown contain the TorcFit connection which provides the rotational indexation. On the other hand, the TLX Gold Abutments for bar/bridge do not have the TorcFit indexation feature since it is used in multiunit restorations. Both versions are available in three different platform diameters, NT (Narrow, TorcFit™), RT (Regular, TorcFit™) and WT (Wide, TorcFit™), allowing the abutments to sit on the shoulders of the corresponding TLX implants. The TLX Gold Abutments have a maximum angulation of 30°, a minimum post height of 4 mm, and a minimum wall thickness of 0.7 mm.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

oral implantation

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)

Bench Testing

An assessment regarding dynamic fatigue testing was conducted according to ISO 14801, Dentistry – Implants – Dynamic fatigue test for endosseous dental implants and 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 subject TLX SRAs and Gold Abutments are equivalent to the primary predicate and reference devices.

The test for the Gold Abutments was conducted in saline (2 Hz and 37°C) at 2 million cycles covering permanent restoration of the implant without failure. The test for the SRA Abutments was a pre-test conducted in ambient air (15 Hz and room temperature) at 5 million cycles covering permanent restoration of the implant without failure.

Biocompatibility Testing

A biological assessment was 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. No new issues of biocompatibility are raised for the subject devices. Therefore, no additional biocompatibility testing was required.

Magnetic Resonance Compatibility

The reference devices K181703 and compatible prosthetics have obtained the status of MR Conditional. No new materials or worst-case constructs are introduced with the subject devices; thus, the previous MRI conditional wording is applicable.

Sterilization, Shelf-life, and Package

SRAs

The subject TLX SRAs are single patient devices and are provided sterile. The sterilization process for the subject TLX SRAs was validated to a sterility assurance level (SAL) of

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

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".

4/8/2022

Institut Straumann AG % Jennifer Jackson Director, Regulatory Affairs Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810

Re: K213063

Trade/Device Name: TLX SRAs and TLX Gold Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: March 9, 2022 Received: March 11, 2022

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 (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 located 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

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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

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.

for Andrew 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

2

Indications for Use

510(k) Number (if known) K213063

Device Name TLX SRAs and TLX Gold Abutments

Indications for Use (Describe) TLX SRAs

Straumann® abutments are indicated to be placed into Straumann® dental implants to provide a support structure for the functional and esthetic oral rehabilitation of edentulous patients with crowns, bridges or full-arch prostheses.

TLX Gold Abutments

Straumann® abutments are indicated to be placed into Straumann® dental implants to provide a support structure for the functional and esthetic oral rehabilitation of edentulous patients with crowns, bridges or full-arch prostheses.

Copings are indirectly connected to the endosseous dental implant and are indicated for use as an aid in prosthetic rehabilitations.

Type of Use (Select one or both, as applicable)
Residential Use (Part 9, OBC 9.36) Select One Day Care Centre Use (Part 9, OBC 9.36) Select One	Residential Use (Part 9, OBC 9.36) Select One		Residential Use (Part 9, OBC 9.36) Select One	Day Care Centre Use (Part 9, OBC 9.36) Select One		Day Care Centre Use (Part 9, OBC 9.36) Select One
Residential Use (Part 9, OBC 9.36) Select One		Residential Use (Part 9, OBC 9.36) Select One	Day Care Centre Use (Part 9, OBC 9.36) Select One		Day Care Centre Use (Part 9, OBC 9.36) Select One
	Residential Use (Part 9, OBC 9.36) Select One
	Day Care Centre Use (Part 9, OBC 9.36) Select One

Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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3

TLX SRAs and TLX Gold Abutments

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:
Institut Straumann AG
Peter Merian-Weg 12
4052 Basel, Switzerland |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jennifer M. Jackson, MS
Director of Regulatory Affairs and Quality
Phone Number: +1-978-747-2509
Fax Number: +1-978-747-0023 |
| Prepared By &
Alternate Contact: | Yu-Ting Chang
International Regulatory Affairs Manager
Institut Straumann AG
Phone number: +41 61 965 1318 |
| Date of Submission: | April 8, 2022 |

Name of the Device

Trade Names:	TLX SRAs and TLX Gold Abutments
Common Name:	Endosseous Dental Implant Abutments
Classification Name:	Endosseous Dental Implant Abutments
Regulation Number:	§872.3630
Device Classification:	II
Product Code(s):	NHA
Classification Panel:	Dental
Proprietary Name:	TLX SRAs and TLX Gold Abutments

4

TLX SRAs and TLX Gold Abutments

510(k) Summary

Predicate Device(s)

Primary Predicate:

K203355 Straumann TLX Novaloc and Cementable Abutments Cementable . Abutments
Reference Devices:
K181703 Straumann® BLX Line Extension Implants, SRAs, and Anatomic Abutments . - SRAs
K200597 BLX Gold Abutments .

Device Description

TLX SRAs

Straumann® TLX SRAs are intended to be placed on TLX Straumann dental implants to provide support for screw-retained single or multi-unit restorations. They are identical in design to the reference devices BLX SRAs cleared as per K181703, except for the laser marking and the anodization. The TLX SRAs have no anodization, but additional laser marking at the connection. The TLX SRAs are provided sterile by gamma radiation. The TLX SRAs are made of TAN (Ti-6Al-7Nb) and are available in angulations of 17° and 30°. The TLX SRAs are secured in the implant through a basal screw made of TAN. The SRAs are provided with a transfer piece (Pin).

TLX Gold Abutments

Straumann TLX Gold Abutments consist of a Ceramicor® alloy base, which is fixed to the implant by means of a basal screw made of Ti-6AI-7Nb, Titanium Aluminum Niobium (TAN). A modelling aid made of POM-C is attached onto the abutment by friction fit when delivered in the package. There are two versions of TLX Gold Abutments: one is for single crown restoration, and the other is for multiunit restoration such as bar or bridge. The TLX Gold Abutments for crown contain the TorcFit connection which provides the rotational indexation. On the other hand, the TLX Gold Abutments for bar/bridge do not have the TorcFit indexation feature since it is used in multiunit restorations. Both versions are available in three different platform diameters, NT (Narrow, TorcFit™), RT (Regular, TorcFit™) and WT (Wide, TorcFit™), allowing the abutments to sit on the shoulders of the corresponding TLX implants. The TLX Gold

5

TLX SRAs and TLX Gold Abutments

510(k) Summary

Abutments have a maximum angulation of 30°, a minimum post height of 4 mm, and a minimum wall thickness of 0.7 mm.

Intended Use

TLX SRAs

Straumann® implants and abutments are intended for use in oral implantation to provide a support structure for connected prosthetic devices.

TLX Gold Abutments

Straumann® dental implants and abutments are intended for oral implantation to provide a support structure for connected prosthetic devices.

Copings are indirectly connected to the endosseous dental implant and are indicated for use as an aid in prosthetic rehabilitations.

Indications for Use

TLX SRAs

Straumann® abutments are indicated to be placed into Straumann® dental implants to provide a support structure for the functional and esthetic oral rehabilitation of edentulous or partially edentulous patients with crowns, bridges, or full-arch prostheses.

TLX Gold Abutments

Straumann® abutments are indicated to be placed into Straumann® dental implants to provide a support structure for the functional and esthetic oral rehabilitation of edentulous or partially edentulous patients with crowns, bridges, or full-arch prostheses.

Copings are indirectly connected to the endosseous dental implant and are indicated for use as an aid in prosthetic rehabilitations.

Technological Characteristics

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

6

TLX SRAs and TLX Gold Abutments

510(k) Summary

TLX SRAs

FEATURE	PROPOSED DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE DEVICE	EQUIVALENCE DISCUSSION
K Number	K213063
Straumann TLX SRAs	K203355
Straumann TLX Cementable
Abutments	K181703
Straumann BLX SRAs
Indications
for Use	Straumann® abutments are
indicated to be placed into
Straumann® dental implants to
provide a support structure for
the functional and esthetic oral
rehabilitation of edentulous or
partially edentulous patients with
crowns, bridges, or full-arch
prostheses.	Prosthetic components directly
connected to the endosseous
dental implant are intended for
use as an aid in prosthetic
rehabilitations. Final abutments
may be placed into occlusion for
implants with sufficient primary
stability and with appropriate
occlusal loading to restore
chewing function or for implants
that are fully osseointegrated	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.	Equivalent.
All allow the abutment to be
place/connected to dental
implants and the purpose is to
aid/support the prosthetic
rehabilitation.
The subject device provides
more detail regarding the type of
rehabilitation These are also
implicitly covered under primary
predicate and reference device.
The final abutment placement
recommendation of the subject
device was moved from the
Indications for Use Statement to
the Caution/Precautions section
of the Instructions for Use since
the loading of the implant body is
inherent to the Indications for
Use of the overarching implant
body clearance.
Therefore, the scope is the same
among subject, primary
predicate, and reference
devices.
Material	Ti-6Al-7Nb (TAN)	Ti-6Al-7Nb (TAN)	Ti-6Al-7Nb (TAN)	Identical
Implant to
Abutment
Connection	TLX TorcFit	TLX TorcFit	BLX TorcFit	Identical
Identical to the primary predicate
device.
FEATURE	PROPOSED DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE DEVICE	EQUIVALENCE DISCUSSION
K Number	K213063
Straumann TLX SRAs	K203355
Straumann TLX Cementable
Abutments	K181703
Straumann BLX SRAs
Platform
Diameter	Ø4.6 mm	4.0 (NT), 5.0 (RT) and 7.0 (WT)	Ø4.6 mm	Identical
Identical to the reference device
Platform	NT	NT, RT, and WT	RB/WB	Identical
Identical to the primary predicate
device.
Heights	3.5 mm	Straight: 5,7 and 6 mm
Angled: 6 mm	1.5, 2.5, 3.5 and 4.5 mm	Identical
Identical to the reference device
Angulation	17° and 30°	0° and 15	0°, 17° and 30°	Identical
Identical to the reference device
Sterilization
Method	Sterile by gamma radiation	Non-sterile	Sterile by gamma radiation	Identical
Identical to the reference device
Prosthesis
type	Screw-retained	Cemented-retained	Screw-retained	Identical
Identical to the reference device
Surface	Not anodized	Not anodized	Anodized	Identical
Identical to the primary predicate
device.
Shelf life	5 years	Without defined shelf life	5 years	Identical
Identical to the reference device
Packaging	Sterile barrier system (blister)
protected by folding box	Non-sterile blister	Sterile barrier system (blister)
protected by folding box	Identical
Identical to the reference device
FEATURE	PROPOSED DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE DEVICE	EQUIVALENCE DISCUSSION
K Number	K213063
Straumann TLX Gold
Abutments	K203355
Straumann TLX Cementable
Abutments	K200597
BLX Gold Abutments
Indications
for Use	Straumann® abutments are
indicated to be placed into
Straumann® dental implants to
provide a support structure for
the functional and esthetic oral
rehabilitation of edentulous or
partially edentulous patients with
crowns, bridges or full-arch
prostheses.
Copings are indirectly connected
to the endosseous dental implant
and are indicated for use as an
aid in prosthetic rehabilitations.	Prosthetic components directly
connected to the endosseous
dental implant are intended for
use as an aid in prosthetic
rehabilitations. Final abutments
may be placed into occlusion for
implants with sufficient primary
stability and with appropriate
occlusal loading to restore
chewing function or for implants
that are fully osseointegrated	Straumann abutments are
intended to be placed into
Straumann dental implants to
provide support for prosthetic
reconstructions such as crowns,
bridges, and overdentures.	Equivalent.
All allow the abutment to be
placed/connected to dental
implants for the purpose of
aiding/supporting the prosthetic
rehabilitation.
The subject device Indications
for Use provides more detail
concerning the rehabilitation. The
indications are also covered
under the primary predicate and
reference devices Indications for
Use.
The final abutment placement
recommendation for the subject
devices was moved from the
Indications for Use Statement to
the Caution/Precautions section
of the Instructions for Use since
the loading of the implant body is
inherent to the Indications for
Use of the overarching implant
body clearance.
The scope of the Indications for
Use is the same among subject,
primary predicate, and reference
devices.
Material	Ceramicor® (base)
TAN (screw)
POM (modeling aid)	Ti-6Al-7Nb (TAN)	Ceramicor® (base)
TAN (screw)
POM (modeling aid)	Identical
Identical to the reference device.
FEATURE	PROPOSED DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE DEVICE	EQUIVALENCE DISCUSSION
K Number	K213063
Straumann TLX Gold
Abutments	K203355
Straumann TLX Cementable
Abutments	K200597
BLX Gold Abutments
Abutment
Shape in
Coronal
Portion	Axial screw access hole for
placement of abutment into
implant	Axial screw access hole for
placement of abutment into
implant	Axial screw access hole for
placement of abutment into
implant	Identical
Identical to the primary predicate
and reference device.
Abutment to
Implant
Connection	TLX TorcFit	TLX TorcFit	BLX TorcFit	Identical
Identical to the primary predicate
device.
Platform
Diameter
(mm)	4.0 (NT), 5.0 (RT) and 7.0 (WT)	4.0 (NT), 5.0 (RT) and 7.0 (WT)	RB/WB: 3.8 and 4.5
WB: 4.5 and 5.5	Identical
Identical to the primary predicate
device.
Post Height
of Stock
Component	NT (3 mm), RT (3.6 mm) and WT
(4 mm)	Straight: 5.7 and 6 mm
Angled: 6 mm	RW/WB and WB: 2.6 mm	Equivalent
The post heights are equivalent
to the reference device. In both
cases, the post provides the
initial support for casting.
Wall
thickness	0.7*	n/a	0.7*	Identical
Subject device and reference
device have a minimum
recommended wall thickness of
0.7mm, as described in the IFU
Angulation	0° and up to 30** after
customization	0° and 15°	0° and up to 30** after
customization	Identical
Identical to the reference device.
Restoration
Type	Crown, Bridge and Full Arch	Crown, Bridge and Full Arch	Crown, Bridge and Full Arch	Identical
Identical to the primary predicate
device.
Sterilization
Method	Non-sterile/
End user sterilized	Non-sterile/
End user sterilized	Non-sterile/
End user sterilized	Identical
Identical to the primary predicate
device.
FEATURE	PROPOSED DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE DEVICE	EQUIVALENCE DISCUSSION
K Number	K213063
Straumann TLX Gold
Abutments	K203355
Straumann TLX Cementable
Abutments	K200597
BLX Gold Abutments
Surface	Not anodized	Not anodized	Not anodized	Identical
Identical to the primary predicate
device.
Restoration
Type	Cemented or screw-retained	Cemented-retained	Cemented or screw-retained	Identical
Identical to the reference device.

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TLX SRAs and TLX Gold Abutments

510(k) Summary

Table 1 – Comparison of subject device versus primary predicate and reference device (SRAs)

8

TLX SRAs and TLX Gold Abutments

510(k) Summary

TLX Gold Abutments

9

TLX SRAs and TLX Gold Abutments

510(k) Summary

10

TLX SRAs and TLX Gold Abutments

510(k) Summary

*Given by the wall thickness upon casting

**Abutments are provided straight (i.e., 0°) but may have an angulation of up to 30° upon casting

Table 2 – Comparison of subject device versus primary predicate and reference device (Gold Abutments)

11

TLX SRAs and TLX Gold Abutments

510(k) Summary

Performance Testing

Bench Testing

An assessment regarding dynamic fatigue testing was conducted according to ISO 14801, Dentistry – Implants – Dynamic fatigue test for endosseous dental implants and 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 subject TLX SRAs and Gold Abutments are equivalent to the primary predicate and reference devices.

The test for the Gold Abutments was conducted in saline (2 Hz and 37°C) at 2 million cycles covering permanent restoration of the implant without failure. The test for the SRA Abutments was a pre-test conducted in ambient air (15 Hz and room temperature) at 5 million cycles covering permanent restoration of the implant without failure.

Biocompatibility Testing

A biological assessment was 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. No new issues of biocompatibility are raised for the subject devices. Therefore, no additional biocompatibility testing was required.

Magnetic Resonance Compatibility

The reference devices K181703 and compatible prosthetics have obtained the status of MR Conditional. No new materials or worst-case constructs are introduced with the subject devices; thus, the previous MRI conditional wording is applicable.

Sterilization, Shelf-life, and Package

SRAs

The subject TLX SRAs are single patient devices and are provided sterile. The sterilization process for the subject TLX SRAs was validated to a sterility assurance level (SAL) of ≤ 10ª in accordance with ISO 11137-1, Sterilization of health care products - Radiation - Part 1:

12

TLX SRAs and TLX Gold Abutments

510(k) Summary

Requirements for development, validation, and routine control of a sterilization process for medical devices.

The shelf life for devices provided sterile is 5 years. The sterilization method and packaging of the subject TLX SRAs is identical to the reference devices K181703.

The subject devices will not be marketed as non-pyrogenicity information provided is based on FDA Guidance on Submission and Review of Sterility Information in Premarket Notification (510(k)) Submission for Devices Labeled as Sterile, issued on 21 January 2016. The method used to determine the device meets pyrogen limit specifications is LAL Endotoxin Analysis with testing limit of 20 EU/device, based on a blood contacting and implanted device.

Gold Abutments

The TLX Gold Abutments are single patient devices and are provided non-sterile. The sterilization procedures reflect the FDA guidance document, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff, Document issued on: March 17, 2015".

These sterilization parameters have been validated to a sterility assurance level (SAL) of ≤10° using the biological indicator (BI) overkill method for the product group, Implant Borne Prosthetics. The subject TLX Gold Abutments do not introduce a new worst case compared to the reference devices K200597.

Conclusion

The documentation submitted in this premarket notification demonstrates the subject TLX SRAs and Gold Abutments are substantially equivalent to the primary predicate devices.