TLX SRAs and TLX Gold Abutments

K213063 · Institut Straumann AG · NHA · Apr 8, 2022 · Dental

Device Facts

• Record ID: K213063
• Device Name: TLX SRAs and TLX Gold Abutments
• Applicant: Institut Straumann AG
• Product Code: NHA · Dental
• Decision Date: Apr 8, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2

Intended Use

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

Device Story

TLX SRAs and TLX Gold Abutments are endosseous dental implant abutments used to support prosthetic restorations (crowns, bridges, full-arch). TLX SRAs are screw-retained components made of Ti-6Al-7Nb (TAN), provided sterile via gamma radiation, and available in 17° and 30° angulations. TLX Gold Abutments consist of a Ceramicor® alloy base with a TAN basal screw and POM-C modeling aid; they are provided non-sterile for end-user sterilization. Both systems connect to Straumann TLX dental implants via the TorcFit connection. Used in clinical dental settings by trained professionals, these devices provide the structural interface between the implant and the final prosthesis. They benefit patients by enabling stable, functional, and esthetic tooth replacement.

Clinical Evidence

Bench testing only. Dynamic fatigue testing performed per ISO 14801. Gold Abutments tested in saline at 2 million cycles; SRA Abutments tested in ambient air at 5 million cycles. Both demonstrated performance equivalent to predicates without failure. Biocompatibility evaluated per ISO 10993-1; no new issues identified.

Technological Characteristics

Materials: Ti-6Al-7Nb (TAN), Ceramicor® alloy, POM-C. Connection: TorcFit. Sterilization: Gamma radiation (SRAs) or end-user sterilization (Gold Abutments). Fatigue testing: ISO 14801. Biocompatibility: ISO 10993-1. Dimensions: 3.5mm height (SRAs); 4mm minimum post height, 0.7mm minimum wall thickness (Gold Abutments).

Indications for Use

Indicated for edentulous or partially edentulous patients requiring functional and esthetic oral rehabilitation with crowns, bridges, or full-arch prostheses. Copings are indicated as an aid in prosthetic rehabilitations.

Regulatory Classification

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.

Special Controls

*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.)

Predicate Devices

• Straumann TLX Novaloc and Cementable Abutments (K203355)

Reference Devices

• Straumann® BLX Line Extension Implants, SRAs, and Anatomic Abutments (K181703)
• BLX Gold Abutments (K200597)

Submission Summary (Full Text)

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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.

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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 ([e-mail]) or phone [phone] 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

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## 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) | | | | | | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|---------------------------------------------------------------------------|
| <table border="0"><tr><td><table border="0"><tr><td><div align="left"> <input checked="checked" type="checkbox"/> </div></td><td><div align="left">Residential Use (Part 9, OBC 9.36) Select One</div></td></tr></table></td><td><table border="0"><tr><td><div align="left"> <input type="checkbox"/> </div></td><td><div align="left">Day Care Centre Use (Part 9, OBC 9.36) Select One</div></td></tr></table></td></tr></table> | <table border="0"><tr><td><div align="left"> <input checked="checked" type="checkbox"/> </div></td><td><div align="left">Residential Use (Part 9, OBC 9.36) Select One</div></td></tr></table> | <div align="left"> <input checked="checked" type="checkbox"/> </div> | <div align="left">Residential Use (Part 9, OBC 9.36) Select One</div> | <table border="0"><tr><td><div align="left"> <input type="checkbox"/> </div></td><td><div align="left">Day Care Centre Use (Part 9, OBC 9.36) Select One</div></td></tr></table> | <div align="left"> <input type="checkbox"/> </div> | <div align="left">Day Care Centre Use (Part 9, OBC 9.36) Select One</div> |
| <table border="0"><tr><td><div align="left"> <input checked="checked" type="checkbox"/> </div></td><td><div align="left">Residential Use (Part 9, OBC 9.36) Select One</div></td></tr></table> | <div align="left"> <input checked="checked" type="checkbox"/> </div> | <div align="left">Residential Use (Part 9, OBC 9.36) Select One</div> | <table border="0"><tr><td><div align="left"> <input type="checkbox"/> </div></td><td><div align="left">Day Care Centre Use (Part 9, OBC 9.36) Select One</div></td></tr></table> | <div align="left"> <input type="checkbox"/> </div> | <div align="left">Day Care Centre Use (Part 9, OBC 9.36) Select One</div> | |
| <div align="left"> <input checked="checked" type="checkbox"/> </div> | <div align="left">Residential Use (Part 9, OBC 9.36) Select One</div> | | | | | |
| <div align="left"> <input type="checkbox"/> </div> | <div align="left">Day Care Centre Use (Part 9, OBC 9.36) Select One</div> | | | | | |

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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## TLX SRAs and TLX Gold Abutments

510(k) Summary

# 510(k) Summary

## Submitter's Contact Information

| Submitter: | Straumann USA, LLC<br>60 Minuteman Road<br>Andover, MA 01810<br>Registration No.: 1222315 Owner/Operator No.: 9005052<br>On the behalf of:<br>Institut Straumann AG<br>Peter Merian-Weg 12<br>4052 Basel, Switzerland |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jennifer M. Jackson, MS<br>Director of Regulatory Affairs and Quality<br>Phone Number: [phone]<br>Fax Number: [phone] |
| Prepared By &<br>Alternate Contact: | Yu-Ting Chang<br>International Regulatory Affairs Manager<br>Institut Straumann AG<br>Phone number: [phone] |
| 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 |

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## 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

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## 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:

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# TLX SRAs and TLX Gold Abutments

510(k) Summary

### TLX SRAs

| FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | EQUIVALENCE DISCUSSION |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K Number | K213063<br>Straumann TLX SRAs | K203355<br>Straumann TLX Cementable<br>Abutments | K181703<br>Straumann BLX SRAs | |
| Indications<br>for Use | Straumann® abutments are<br>indicated to be placed into<br>Straumann® dental implants to<br>provide a support structure for<br>the functional and esthetic oral<br>rehabilitation of edentulous or<br>partially edentulous patients with<br>crowns, bridges, or full-arch<br>prostheses. | Prosthetic components directly<br>connected to the endosseous<br>dental implant are intended for<br>use as an aid in prosthetic<br>rehabilitations. Final abutments<br>may be placed into occlusion for<br>implants with sufficient primary<br>stability and with appropriate<br>occlusal loading to restore<br>chewing function or for implants<br>that are fully osseointegrated | Prosthetic components directly<br>or indirectly connected to the<br>endosseous dental implant are<br>intended for use as an aid in<br>prosthetic rehabilitations.<br>Temporary components can be<br>used prior to the insertion of the<br>final components to maintain,<br>stabilize and shape the soft<br>tissue during the healing phase;<br>they may not be placed into<br>occlusion. Final abutments may<br>be placed into occlusion when<br>the implant is fully<br>osseointegrated. BLX Temporary<br>Abutments have a maximum<br>duration of usage of 180 days. | Equivalent.<br>All allow the abutment to be<br>place/connected to dental<br>implants and the purpose is to<br>aid/support the prosthetic<br>rehabilitation.<br>The subject device provides<br>more detail regarding the type of<br>rehabilitation These are also<br>implicitly covered under primary<br>predicate and reference device.<br>The final abutment placement<br>recommendation of the subject<br>device was moved from the<br>Indications for Use Statement to<br>the Caution/Precautions section<br>of the Instructions for Use since<br>the loading of the implant body is<br>inherent to the Indications for<br>Use of the overarching implant<br>body clearance.<br>Therefore, the scope is the same<br>among subject, primary<br>predicate, and reference<br>devices. |
| Material | Ti-6Al-7Nb (TAN) | Ti-6Al-7Nb (TAN) | Ti-6Al-7Nb (TAN) | Identical |
| Implant to<br>Abutment<br>Connection | TLX TorcFit | TLX TorcFit | BLX TorcFit | Identical<br>Identical to the primary predicate<br>device. |
| FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | EQUIVALENCE DISCUSSION |
| K Number | K213063<br>Straumann TLX SRAs | K203355<br>Straumann TLX Cementable<br>Abutments | K181703<br>Straumann BLX SRAs | |
| Platform<br>Diameter | Ø4.6 mm | 4.0 (NT), 5.0 (RT) and 7.0 (WT) | Ø4.6 mm | Identical<br>Identical to the reference device |
| Platform | NT | NT, RT, and WT | RB/WB | Identical<br>Identical to the primary predicate<br>device. |
| Heights | 3.5 mm | Straight: 5,7 and 6 mm<br>Angled: 6 mm | 1.5, 2.5, 3.5 and 4.5 mm | Identical<br>Identical to the reference device |
| Angulation | 17° and 30° | 0° and 15 | 0°, 17° and 30° | Identical<br>Identical to the reference device |
| Sterilization<br>Method | Sterile by gamma radiation | Non-sterile | Sterile by gamma radiation | Identical<br>Identical to the reference device |
| Prosthesis<br>type | Screw-retained | Cemented-retained | Screw-retained | Identical<br>Identical to the reference device |
| Surface | Not anodized | Not anodized | Anodized | Identical<br>Identical to the primary predicate<br>device. |
| Shelf life | 5 years | Without defined shelf life | 5 years | Identical<br>Identical to the reference device |
| Packaging | Sterile barrier system (blister)<br>protected by folding box | Non-sterile blister | Sterile barrier system (blister)<br>protected by folding box | Identical<br>Identical to the reference device |
| FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | EQUIVALENCE DISCUSSION |
| K Number | K213063<br>Straumann TLX Gold<br>Abutments | K203355<br>Straumann TLX Cementable<br>Abutments | K200597<br>BLX Gold Abutments | |
| Indications<br>for Use | Straumann® abutments are<br>indicated to be placed into<br>Straumann® dental implants to<br>provide a support structure for<br>the functional and esthetic oral<br>rehabilitation of edentulous or<br>partially edentulous patients with<br>crowns, bridges or full-arch<br>prostheses.<br>Copings are indirectly connected<br>to the endosseous dental implant<br>and are indicated for use as an<br>aid in prosthetic rehabilitations. | Prosthetic components directly<br>connected to the endosseous<br>dental implant are intended for<br>use as an aid in prosthetic<br>rehabilitations. Final abutments<br>may be placed into occlusion for<br>implants with sufficient primary<br>stability and with appropriate<br>occlusal loading to restore<br>chewing function or for implants<br>that are fully osseointegrated | Straumann abutments are<br>intended to be placed into<br>Straumann dental implants to<br>provide support for prosthetic<br>reconstructions such as crowns,<br>bridges, and overdentures. | Equivalent.<br>All allow the abutment to be<br>placed/connected to dental<br>implants for the purpose of<br>aiding/supporting the prosthetic<br>rehabilitation.<br>The subject device Indications<br>for Use provides more detail<br>concerning the rehabilitation. The<br>indications are also covered<br>under the primary predicate and<br>reference devices Indications for<br>Use.<br>The final abutment placement<br>recommendation for the subject<br>devices was moved from the<br>Indications for Use Statement to<br>the Caution/Precautions section<br>of the Instructions for Use since<br>the loading of the implant body is<br>inherent to the Indications for<br>Use of the overarching implant<br>body clearance.<br>The scope of the Indications for<br>Use is the same among subject,<br>primary predicate, and reference<br>devices. |
| Material | Ceramicor® (base)<br>TAN (screw)<br>POM (modeling aid) | Ti-6Al-7Nb (TAN) | Ceramicor® (base)<br>TAN (screw)<br>POM (modeling aid) | Identical<br>Identical to the reference device. |
| FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | EQUIVALENCE DISCUSSION |
| K Number | K213063<br>Straumann TLX Gold<br>Abutments | K203355<br>Straumann TLX Cementable<br>Abutments | K200597<br>BLX Gold Abutments | |
| Abutment<br>Shape in<br>Coronal<br>Portion | Axial screw access hole for<br>placement of abutment into<br>implant | Axial screw access hole for<br>placement of abutment into<br>implant | Axial screw access hole for<br>placement of abutment into<br>implant | Identical<br>Identical to the primary predicate<br>and reference device. |
| Abutment to<br>Implant<br>Connection | TLX TorcFit | TLX TorcFit | BLX TorcFit | Identical<br>Identical to the primary predicate<br>device. |
| Platform<br>Diameter<br>(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<br>WB: 4.5 and 5.5 | Identical<br>Identical to the primary predicate<br>device. |
| Post Height<br>of Stock<br>Component | NT (3 mm), RT (3.6 mm) and WT<br>(4 mm) | Straight: 5.7 and 6 mm<br>Angled: 6 mm | RW/WB and WB: 2.6 mm | Equivalent<br>The post heights are equivalent<br>to the reference device. In both<br>cases, the post provides the<br>initial support for casting. |
| Wall<br>thickness | 0.7*…