Straumann TLX Implant System

K200586 · Institut Straumann AG · DZE · Aug 20, 2020 · Dental

Device Facts

• Record ID: K200586
• Device Name: Straumann TLX Implant System
• Applicant: Institut Straumann AG
• Product Code: DZE · Dental
• Decision Date: Aug 20, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Straumann TLX Implants are suitable for endosteal implantation in the upper and lower jaws and for the functional and esthetic oral rehabilitation of edentulous and partially edentulous patients. TLX Implants can be placed with immediate function on single-tooth and multi-unit restorations 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. Straumann Closure Caps and Healing Caps are indicated to be placed in the patient's mouth at the end of the implant placement to protect the inner configuration of the implant and to form, maintain and stabilize the soft tissue during the healing process. Closure caps and healing caps should be used only with suitable implant connections. They have a maximum duration of usage of 6 months. TLX Temporary Abutments 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. TLX Temporary Abutments have a maximum duration of usage of 180 days. Straumann Variobase prosthetic components directly 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 CARES Abutments TAN are indicated for single tooth replacement and multiple tooth restorations. The prosthetic restoration can be cemented. CARES Screw-retained Bridges and Bars (SRBB) are indicated for use as bars and bridges that attach to implants to provide support for prosthetic reconstructions such as bridges and overdentures. The final processed products have the purpose of restoring function. Straumann CARES Screw-retained Bridges and Bars are indicated for Screw-retained restorations. Straumann CARES Screw-retained Bridges and Bars are designed to interface with the Bone Level (BL), Tissue Level (TL), BLX implants and TLX implants of the Straumann Dental Implant System (SDIS).

Device Story

System comprises fully tapered endosseous dental implants (Roxolid material, SLActive surface) and prosthetic components (closure/healing caps, temporary abutments, Variobase, CARES abutments, screw-retained bridges/bars). Implants placed in clinic by dental professionals; provide foundation for prosthetic restorations. Digital workflow utilizes Straumann CARES Visual software for CAD design of copings/crowns/bridges, manufactured at validated milling centers. Components connect via TorcFit conical interface. Temporary components stabilize soft tissue during healing; final restorations provide chewing function. Benefits include immediate function capability and customized prosthetic fit.

Clinical Evidence

Bench testing only. Dynamic fatigue testing conducted per FDA guidance in saline and air. Surface area and pull-out force testing performed on Ø3.75 x 6 mm implants. Biocompatibility assessed per ISO 10993-1. Sterilization validated per ISO 11137 and ISO 17665.

Technological Characteristics

Materials: Roxolid (Ti-13Zr), Titanium Grade 4, TAN (Ti-6Al-7Nb), CoCr. Surface: SLActive (hydrophilic). Connection: TorcFit (conical). Design: Tapered body, tulip-shaped neck. Sterilization: Irradiation (sterile components) or steam autoclave (non-sterile). Software: CAD/CAM digital workflow (Straumann CARES Visual).

Indications for Use

Indicated for edentulous and partially edentulous patients requiring endosteal dental implants in upper or lower jaws for functional and esthetic oral rehabilitation. Supports single-tooth and multi-unit restorations, including immediate function when primary stability is achieved. Includes components for soft tissue healing, temporary abutments, and prosthetic support (crowns, bridges, bars).

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Straumann BLX Implant System (K173961)

Reference Devices

• Straumann BLX Line Extension (K181703)
• Straumann Dental implant system (K171784)
• Straumann BLX Variobase Abutment (K190082)
• BLX Line Extension New Abutments (K190040)
• Straumann CARES Bone Level Screw-retained Bars, STRAUMANN CARES Bone Level Screw-retained Bridges (K132844)
• Straumann CARES Screw-retained Bridge Titanium, STRAUMANN CARES Dolder Bar Titanium (K112280)
• Straumann CARES Bridge; STRAUMANN CARES Dolder Bar (K101465)
• Straumann CARES Screw-retained Bridges and Bars (K190097)
• MRI Compatibility for Existing Straumann Dental Implant Systems (K190062)
• Straumann Dental Implant System Roxolid SLA Implants (K150938)
• Neodent Implant System GM Line (K163194)
• Straumann CARES Abutments CoCr (K172798)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 20, 2020

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

Re: K200586

Trade/Device Name: Straumann TLX Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: July 21, 2020 Received: July 22, 2020

### 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental 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) K200586

#### Device Name Straumann TLX Implant System

#### Indications for Use (Describe)

#### TLX Dental Implant:

Straumann TLX Implants are suitable for endosteal implantation in the upper and for the functional and esthetic oral rehabilitation of edentulous patients. TLX Implants can be placed with immediate function on single-tooth and multi-unit restorations 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.

#### TLX Closure Caps and Healing Caps:

Straumann Closure Caps and Healing Caps are indicated to be placed in the patient's mouth at the end of the implant placement to protect the inner configuration of the implant and stabilize the soft tissue during the healing process. Closure caps and healing caps should be used only with suitable implant connections. They have a maximum duration of usage of 6 months.

#### TLX Temporary Abutment:

TLX Temporary Abutments can be used prior to the final components to maintain, stabilize and shape the soft tissue during the healing phase; they may not be placed into occlusion. TLX Temporary Abutments have a maximum duration of usage of 180 days.

#### TLX Variobase for Crown:

Straumann Variobase prosthetic components directly 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 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 osseontegrated. 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.

#### TLX CARES Abutment TAN:

The Straumann CARES Abutments TAN are indicated for single tooth replacement and multiple tooth restorations. The prosthetic restoration can be cemented.

#### TLX Screw-retained Bridges and Bars:

CARES Screw-retained Bridges and Bars (SRBB) are indicated for use as bars and bridges that attach to implants to provide support for prosthetic reconstructions such as bridges and overdentures. The final processed products have the purpose of restoring chewing function. Straumann CARES Screw-retained Bridges and Bars are indicated for Screw-retained restorations. Straumann CARES Screw-retained Bridges and Bars are designed to interface with the Bone Level (BL), Tissue Level (TL), BLX implants of the Straumann Dental Implant System (SDIS).

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.

{3}------------------------------------------------

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 [e-mail]

"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}------------------------------------------------

Straumann® TLX Implant System

Substantial Equivalence Discussion

#### 510(k) Summary 5

#### 5.1 Submitter's Contact Information

| Submitter: | Straumann USA, LLC (on behalf of Institut Straumann AG)<br>60 Minuteman Road<br>Andover, MA 01810 | | |
|-------------------|---------------------------------------------------------------------------------------------------------------------------|---------------------|---------|
| Registration No.: | 1222315 | Owner/Operator No.: | 9005052 |
| | 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<br>Phone Number: [phone]<br>Fax Number: [phone] | | |
| Prepared By: | Renate Reiss<br>Regulatory Affairs and Compliance Manager<br>Institut Straumann AG<br>Phone number: [phone] | | |
| Date Prepared: | August 19, 2020 | | |

#### 5.2 Name of the Device

| Trade Names: | Straumann TLX Implant System |
|------------------------|------------------------------------------------------------|
| Common Name: | Endosseous dental implant |
| Classification Name: | Endosseous dental implant |
| Regulation Number: | §872.3640 |
| Device Classification: | II |
| Product Code(s): | Primary product code – DZE<br>Secondary product code – NHA |

{5}------------------------------------------------

### Straumann® TLX Implant System

Substantial Equivalence Discussion

#### Predicate Device(s) 5.3

Primary Predicate:

- K173961 Straumann BLX Implant System .
Reference Devices:

- K181703 Straumann® BLX Line Extension .
- K171784 Straumann Dental implant system .
- . K190082 – Straumann BLX Variobase Abutment
- K190040 BLX Line Extension New Abutments .
- K132844 Straumann CARES Bone Level Screw-retained Bars, STRAUMANN CARES . Bone Level Screw-retained Bridges
- K112280 Straumann CARES Screw-retained Bridge Titanium, STRAUMANN CARES . Dolder Bar Titanium
- K101465 Straumann CARES Bridge; STRAUMANN CARES Dolder Bar .
- . K190097 – Straumann CARES Screw-retained Bridges and Bars
- K190662 MRI Compatibility for Existing Straumann Dental Implant Systems ●
- K150938 Straumann Dental Implant System Roxolid SLA Implants .
- K163194 Neodent Implant System GM Line .
- . K172798 – Straumann CARES Abutments CoCr

#### Device Description 5.4

### TLX Dental Implant:

The TLX Dental Implant are fully tapered implants manufactured utilizing the Roxolid material and are finished with SLActive surface. The connection is identified as conical fitting with Torx style engaging feature. TLX implants are presented with 3 prosthetic platforms as listed below:

- . NT (Narrow TorcFit)
- RT (Regular TorcFit) .
- WT (Wide TorcFit) .

The internal connection is identical for all prosthetic platforms, implant diameters, and implant lengths.

{6}------------------------------------------------

### Straumann® TLX Implant System

Substantial Equivalence Discussion

#### TLX Closure Caps and Healing Caps:

The closure caps are screwed into the implant to protect the inner configuration and shoulder of the implant during the healing phase in cases of submucosal) healing protocols. The healing caps are screwed into the implant to protect the inner configuration of the implant in cases of transmucosal healing protocols. They are placed out of occlusion and do not support a prosthetic restoration. Closure caps and healing caps are used during the healing phase only.

The TLX Closure Caps and Healing Caps are manufactured from Titanium Grade 4 and are laser marked with NT, RT or WT for identification purposes. They are provided sterile and are available in different heights and diameters.

#### TLX Temporary Abutment

TLX Temporary Abutments 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.

TLX Temporary Abutments have a maximum duration of usage of 180 days.

The TLX Temporary Abutments are manufactured from TAN and consist of a coronal section, a platform and a connection part. The abutments are provided non-sterile with instructions for end user sterilization. The Temporary Abutments are seated in the implant with a basal screw which is also manufactured from TAN and are laser marked with NT, RT or WT for identification purposes. The Basal screw is delivered with the abutment. The TLX Temporary Abutments are available for Crown and Bridge/Bar restorations.

### TLX Variobase for Crown

The TLX Variobase for Crown incorporates the implant to abutment connection (TorcFit) and is available for each of the three implant diameter platforms (NT, RT & WT) with a different abutment chimney height and prosthetic platform diameter. The TLX Variobase Abutments for Crown are titanium bases to be used as the lower part of two-piece abutments. The upper part of the two-piece abutment is a CAD/CAM designed and manufactured restoration. These components, which once assembled together and placed with the corresponding basal screw, constitute the final medical device.

TLX Variobase for Crown will be marketed as stand-alone component or through the CARES® X-Stream workflow. In the latter the prosthetic restoration is designed though CARES® Visual

{7}------------------------------------------------

### Straumann® TLX Implant System

Substantial Equivalence Discussion

software (Digital CARES workflow) and manufactured in a validated Straumann milling center. The prosthetic restoration is then shipped together with the TLX Variobase for Crown and the Basal screw.

All digitally designed copings and/or crowns for use with the TLX Variobase for Crown are intended to be sent to Straumann for manufacture at a validated milling center.

The TLX Variobase for Crown is provided non-sterile with instructions for end user steam sterilization.

### Prosthetic Restoration Design and Materials

The following materials are available within the digital workflow for the manufacturing of prosthetic restorations:

Final restorations:

- . zerion® LT
- . zerion® ML
- zerion® UTML ●
- IPS e.max CAD .
- coron® .

Temporary restoration:

- polycon® ae .
### TLX CARES Abutment TAN

The TLX CARES Abutments TAN are packed and delivered with the Basel screw. Both are manufactured from TAN (titanium-aluminum-niobium alloy/ Ti-6AI-7Nb).

TLX CARES Abutments TAN are intended to be placed into Straumann implants to provide support for prosthetic reconstructions such as crowns and bridges.

The final abutment, fabricated from a pre-milled blank, is designed to allow for individual customization regarding function and esthetics.

The pre-milled blank incorporates the pre-milled implant to abutment connection (TorcFit) and has a cylindrical body with enough material volume to create a wide range of geometries for the final abutment.

The TLX CARES Abutments TAN is available for each of the three implant platforms.

{8}------------------------------------------------

### Straumann® TLX Implant System

Substantial Equivalence Discussion

Inside the abutment, a screw channel provides access to the internal thread feature of the implant, such that the component can be firmly attached while providing fit between screw, abutment and implant.

The design of the customized abutment must be made using the validated Straumann CARES Visual software (Digital CARES workflow).

Finally, the design file is transferred digitally to a Straumann validated milling center.

The TLX CARES Abutment TAN is provided non-sterile with instructions for end user steam sterilization.

### TLX Screw-retained Bridges and Bars:

The Straumann CARES Screw-retained Bridges and Bars, also referred to as SRBB are packed and delivered with the corresponding basal screws.

SRBB devices are manufacture from either

- . Titanium Grade 4 or
- . Cobalt chromium (also referred to as CoCr (or coron).
- . the Basal Screw is manufactured from TAN (titanium-aluminum-niobium alloy/ Ti-6Al-7Nb).

SRBB are used for the restoration of Straumann dental implants with different endosteal diameters, lengths and platforms.

- CARES bars are to be combined with an overdenture to treat edentulous cases. .
- . CARES fixed bars are superstructures for the direct application with dental resin and prefabricated teeth to treat edentulous cases.
- . CARES Screw-retained Bridges are intended to be directly veneered with dental veneering ceramics.

The purpose of this premarket notification is to expand the currently cleared abutment-toimplant interfaces to include the TLX implant system.

The SRBB devices are available for each of the three prosthetic platforms (NT, RT, WT).

The design of the SRBB devices must be made using the validated Straumann CARES Visual software (Digital CARES workflow).

Finally, the design file is transferred digitally to a Straumann validated milling center.

{9}------------------------------------------------

# Straumann® TLX Implant System

Substantial Equivalence Discussion

The TLX SRBB are provided non-sterile with instructions for end user steam sterilization.

#### TLX Basal screw

The Basal screw is used to seat the temporary abutments, the TLX Variobase Abutments or the TLX Screw-retained Bridges and Bars to the dental implant and can be also be used during lab procedures to fix lab prosthetic parts on implant analogs. They are provided along the prosthetic components, but they are also provided as standalone screws. The TLX basal screws is manufactured from TAN.

#### Indications for Use 5.5

#### TLX Dental Implant:

Straumann TLX Implants are suitable for endosteal implantation in the upper and lower jaws and for the functional and esthetic oral rehabilitation of edentulous and partially edentulous patients. TLX Implants can be placed with immediate function on single-tooth and multi-unit restorations 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.

#### TLX Closure Caps and Healing Caps:

Straumann Closure Caps and Healing Caps are indicated to be placed in the patient's mouth at the end of the implant placement to protect the inner configuration of the implant and to form, maintain and stabilize the soft tissue during the healing process. Closure caps and healing caps should be used only with suitable implant connections. They have a maximum duration of usage of 6 months.

#### TLX Temporary Abutment:

TLX Temporary Abutments 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. TLX Temporary Abutments have a maximum duration of usage of 180 days.

#### TLX Variobase for Crown:

Straumann Variobase prosthetic components directly 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

{10}------------------------------------------------

# Straumann® TLX Implant System

### Substantial Equivalence Discussion

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.

### TLX CARES Abutment TAN:

The Straumann CARES Abutments TAN are indicated for single tooth replacement and multiple tooth restorations. The prosthetic restoration can be cemented.

### TLX Screw-retained Bridges and Bars:

CARES Screw-retained Bridges and Bars (SRBB) are indicated for use as bars and bridges that attach to implants to provide support for prosthetic reconstructions such as bridges and overdentures. The final processed products have the purpose of restoring function. Straumann CARES Screw-retained Bridges and Bars are indicated for Screw-retained restorations. Straumann CARES Screw-retained Bridges and Bars are designed to interface with the Bone Level (BL), Tissue Level (TL), BLX implants and TLX implants of the Straumann Dental Implant System (SDIS).

#### Technological Characteristics 5.6

The technological characteristics of the subject devices are compared to the primary predicate and reference devices in Table 1 through Table 6. Regarding the technological characteristics of the Implants described in Table 1, the following describes the relevant equivalence discussion:

- K150938 was introduced for comparison between the subject Ø3.75 x 6 mm and the . reference Ø4.1 x 6 mm implant. In order to address the difference in the diameter/thread design, surface area comparison as well as pull-out strength were conducted to demonstrate equivalence.
- K163194 was introduced for comparison between the subject Ø5.0 x 18 mm and the . reference Ø5.0 x 18 mm implant.
- K171784 and K150938 were introduced for comparison of the implant neck shape. .

{11}------------------------------------------------

# Straumann® TLX Implant System

# Substantial Equivalence Discussion

| | Proposed Device | Primary Predicate<br>Device | Reference Device | Reference Device | Reference Device | Reference Device |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | K200586<br>Straumann TLX Implant<br>System | K173961<br>Straumann BLX<br>Implant System | K181703<br>Straumann® BLX<br>Line Extension | K171784<br>Straumann Dental<br>implant system | K150938<br>Roxolid SLA Implants | K163194<br>Neodent Implant<br>System - GM Line |
| Indications for<br>Use | Straumann TLX Implants<br>are suitable for endosteal<br>implantation in the upper<br>and lower jaws and for<br>the functional and<br>esthetic oral rehabilitation<br>of edentulous and<br>partially edentulous<br>patients. TLX Implants<br>can be placed with<br>immediate function on<br>single-tooth and multi-unit<br>restorations when good<br>primary stability is<br>achieved and with<br>appropriate occlusal<br>loading to restore<br>chewing function. The<br>prosthetic restorations are<br>connected to the implants<br>through the<br>corresponding abutment<br>components. | Straumann® BLX<br>Implants are suitable for<br>endosteal implantation<br>in the upper and lower<br>jaw and for the<br>functional and esthetic<br>oral rehabilitation of<br>edentulous and partially<br>edentulous patients.<br>BLX Implants can be<br>placed with immediate<br>function on single-tooth<br>applications when good<br>primary stability is<br>achieved and with<br>appropriate occlusal<br>loading to restore<br>chewing function. The<br>prosthetic restorations<br>are connected to the<br>implants through the<br>corresponding abutment<br>components. | Straumann® BLX<br>Implants are suitable<br>for endosteal<br>implantation in the<br>upper and lower jaw<br>and for the functional<br>and esthetic oral<br>rehabilitation of<br>edentulous and<br>partially edentulous<br>patients. BLX Implants<br>can be placed with<br>immediate function on<br>single-tooth, bar and<br>bridge applications<br>when good primary<br>stability is achieved<br>and with appropriate<br>occlusal loading to<br>restore chewing<br>function. The<br>prosthetic restorations<br>are connected to the<br>implants through the<br>corresponding<br>abutment components. | Straumann® Dental<br>implants are indicated for<br>oral endosteal<br>implantation in the upper<br>and lower jaw arches and<br>for the functional and<br>aesthetic oral<br>rehabilitation of<br>edentulous and partially<br>dentate patients.<br>Straumann® Dental<br>implants are also<br>indicated for immediate or<br>early implantation<br>following extraction or loss<br>of natural teeth. Implants<br>can be placed with<br>immediate function on<br>single-tooth and/or<br>multiple-tooth applications<br>when good primary<br>stability is achieved and<br>with appropriate occlusal<br>loading to restore chewing<br>function. The prosthetic<br>restorations used are<br>single crowns, bridges<br>and partial or full<br>dentures, which are<br>connected to the implants<br>through the corresponding<br>components (abutments). | Straumann® Dental<br>implants are indicated for<br>oral endosteal<br>implantation in the upper<br>and lower jaw arches and<br>for the functional and<br>aesthetic oral<br>rehabilitation of<br>edentulous and partially<br>dentate patients.<br>Straumann® Dental<br>implants are also<br>indicated for immediate or<br>early implantation<br>following extraction or<br>loss of natural teeth.<br>Implants can be placed<br>with immediate function<br>on single-tooth and/or<br>multiple-tooth applications<br>when good primary<br>stability is achieved and<br>with appropriate occlusal<br>loading to restore<br>chewing function. The<br>prosthetic restorations<br>used are single crowns,<br>bridges and partial or full<br>dentures, which are<br>connected to the implants<br>through the<br>corresponding<br>components (abutments). | The Neodent Implant<br>System is intended to be<br>surgically placed in the<br>bone of the upper or<br>lower jaw to provide<br>support for prosthetic<br>devices such as artificial<br>teeth, to restore chewing<br>function. It may be used<br>with single-stage or two-<br>stage procedures, for<br>single or multiple unit<br>restorations, and may be<br>loaded immediately<br>when good primary<br>stability is achieved and<br>with appropriate occlusal<br>loading. |
| Material | Titanium-13 Zirconium<br>alloy (Roxolid®) | Titanium-13 Zirconium<br>alloy (Roxolid®) | Titanium-13 Zirconium<br>alloy (Roxolid®) | Titanium-13 Zirconium<br>alloy<br>(Roxolid®) | Titanium-13 Zirconium<br>alloy<br>(Roxolid®) | Titanium grade 4 |
| | Proposed Device | Primary Predicate<br>Device | Reference Device | Reference Device | Reference Device | Reference Device |
| Feature | K200586<br>Straumann TLX Implant<br>System | K173961<br>Straumann BLX<br>Implant System | K181703<br>Straumann® BLX<br>Line Extension | K171784<br>Straumann Dental<br>implant system | K150938<br>Roxolid SLA Implants | K163194<br>Neodent Implant<br>System - GM Line |
| Surface<br>Treatment | Hydrophilic SLActive® | Hydrophilic SLActive® | Hydrophilic SLActive® | Hydrophilic SLActive® | SLA | Neoporos<br>Acqua |
| Implant to<br>Abutment<br>Connection | TorcFit<br>(with conical fitting) | TorcFit<br>(with conical fitting) | TorcFit<br>(with conical fitting) | Narrow CrossFit (NC)<br>Regular CrossFit (RC)<br>Regular Neck (RN)<br>Wide Neck (WN) | Narrow CrossFit (NC)<br>Regular CrossFit (RC)<br>Narrow Neck CrossFit<br>(NNC)<br>Regular Neck (RN)<br>Wide Neck (WN) | GM interface; 16° Morse<br>taper with anti-rotational<br>features. |
| Implant<br>Diameter | Ø3.75, 4.0, 4.5, 5.0, 5.5,<br>and 6.5 mm | Ø4.5, 5.5, and 6.5 mm | Ø3.75 mm | Ø3.3, 4.1, and 4.8 mm | Ø3.3, 4.1, and 4.8 mm | Ø3.5 to 5.0 mm |
| Implant Length | Ø3.75, 4.0, 4.5, 5.0 mm:<br>6, 8, 10, 12, 14, 16 and<br>18 mm<br>Ø5.5 and 6.5 mm:<br>6, 8, 10, 12 mm | 6 to 18 mm | 8 to 18 mm | 6 to 18 mm | 6, 8, 10, 12, 14, 16 mm | 8 to 18 mm |
| Implant Design | Tapered body | Tapered body | Tapered body | Parallel wall and bone<br>level tapered (BLT) | Parallel wall and bone<br>level tapered (BLT) | Titamax<br>Helix<br>Drive |
| Implant neck | Tulip shape | n/a (bone level) | n/a (bone level) | Tulip shape<br>n/a (bone level) | Tulip shape<br>n/a (bone level) | n/a (bone level) |
| Prosthetic<br>platforms | NT, RT, and WT | RB and WB | RB and WB | RN, WN, RC, and NC | NC, RC, NNC, RN, and<br>WN | GM interface |
| Thread Pitch | 1.7, 2.0, 2.1, 2.2, 2.5, 2.6,<br>and 2.8 mm | 2.0 to 2.8 mm | 1.7 to 2.6 mm | 0.8 and 1.25 mm | 0.8 and 1.25 mm…