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).

Device Description

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.

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 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.

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.

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.

AI/ML Overview

The provided document is an FDA 510(k) premarket notification for the Straumann TLX Implant System. It primarily focuses on demonstrating substantial equivalence to predicate devices through comparisons of indications for use, technological characteristics, and performance testing (bench testing, biocompatibility, sterilization, and software validation).

Crucially, this document does not contain information about a study proving that the device meets specific acceptance criteria in terms of human-in-the-loop performance with AI assistance, or standalone algorithm performance, as would be expected for an AI/ML medical device submission.

The document describes a dental implant system (a physical device), not an Artificial Intelligence/Machine Learning (AI/ML) powered medical device. Therefore, the questions related to AI/ML device performance (such as MRMC studies, standalone algorithm performance, number of experts for ground truth, training/test set sample sizes for AI, etc.) are not applicable to the content of this 510(k) submission.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the device's ability to meet the substantial equivalence criteria established by the FDA for its intended use, when compared to legally marketed predicate devices. This is demonstrated through various tests and comparisons, as outlined in section 5.7 "Performance Testing".

However, to answer your request as literally as possible, based on the information provided for this non-AI/ML device, I will extract the relevant "acceptance criteria" and descriptions of "studies" as they pertain to a traditional medical device submission for a physical product.

Based on the provided document (K200586 for the Straumann TLX Implant System), which describes a physical dental implant system and not an AI/ML medical device, the following information can be extracted:

The "acceptance criteria" for this device are implicitly tied to demonstrating substantial equivalence to existing predicate devices, as required for a 510(k) submission. The "studies" are the performance tests conducted to support this claim of substantial equivalence.

1. A table of acceptance criteria and the reported device performance:

Since this is not an AI/ML device, the acceptance criteria are not in terms of traditional metrics like accuracy, sensitivity, or specificity for an algorithm. Instead, they relate to mechanical, biological, and processing characteristics that are equivalent or superior to predicate devices.

Acceptance Criteria (Implicit for Substantial Equivalence)	Reported Device Performance/Comparison (from Section 5.6 & 5.7)
Mechanical Performance (Dynamic Fatigue)	TLX Dental Implant System: "Dynamic fatigue tests were conducted according to the FDA guidance document... and demonstrated the TLX Dental Implant system is equivalent to the predicate and reference devices." - Tests performed in saline (2 Hz, 37°C) for 2 million cycles (permanent) and 200,000 cycles (temporary). - Tests performed in air (15 Hz) for 5 million cycles (permanent) and 500,000 cycles (temporary).
Endosseous Surface Area & Pull-Out Force (for specific implants)	TLX Dental Implant: "Surface area comparison and pull-out testing were performed on the Ø3.75 x 6 mm NT implants and were determined to have a larger endosseous surface area and higher pull-out force compared to the reference Ø4.1 x 6 mm device."
Biocompatibility	All TLX Components: "Biological assessment has been performed according to ISO 10993-1:2009... and to the FDA Guidance document... The subject device materials are identical to the predicate and reference device materials, therefore, no new issues regarding biocompatibility were raised."
Sterilization Assurance Level (SAL) for Sterile Components	TLX Implants & Healing/Closure Caps (Sterile): "A sterility assurance level (SAL) of 10-6 had been validated in accordance with ISO 11137-1:2006... The validation method used was the over kill bioburden method in accordance with ISO 11137-2:2013."
Pyrogenicity Limit	TLX Implants & Healing/Closure Caps (Sterile): "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." (Note: The device is not marketed as non-pyrogenic but pyrogenicity info is provided.)
End-User Sterilization Validation (for Non-Sterile Components)	TLX Temporary Abutments, Variobase for Crown, CARES Abutment TAN, SRBB (Non-Sterile): "The recommended sterilization has been validated according to ISO 17665-1 and ISO 17665-2 and to applicable recommendations in the FDA guidance document 'Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling'." "There are no changes to the sterilization procedures or processes from those of the Straumann predicate devices."
Software Validation (for CAD/CAM components)	Software for CAD/CAM: "Software validation testing were conducted and documentation was provided according to the FDA guidance documents 'Class II Special Controls Guidance Document: Optical Impression Systems for Computer Assisted Design and Manufacturing (CAD/CAM) of Dental Restorations' and 'General Principles of Software Validation; Final Guidance for Industry and FDA Staff'. The software for this device was considered as a 'moderate' level of concern."
Material Equivalence	TLX Dental Implant: Roxolid® (Titanium-13 Zirconium alloy), same as primary predicate. TLX Closure Caps/Healing Caps: Titanium Grade 4, same as primary predicate. TLX Temporary Abutment, Variobase, CARES Abutment TAN, Basal Screw: TAN (Ti-6Al-7Nb), same as predicate/reference. TLX Screw-retained Bridges and Bars: Titanium Grade 4 or Cobalt Chromium, with TAN screw. Materials consistent with predicate devices.
Surface Treatment Equivalence	TLX Dental Implant: Hydrophilic SLActive®, same as primary predicate.
Implant-to-Abutment Connection Equivalence	TLX Dental Implant: TorcFit (with conical fitting), same as primary predicate.
Manufacturing Workflow Equivalence (for CAD/CAM components)	Variobase for Crown, CARES Abutment TAN, SRBB: "Straumann Milling" / "Digital CARES workflow via Straumann milling center", consistent with predicate/reference.
Design Workflow Equivalence (for CAD/CAM components)	Variobase for Crown, CARES Abutment TAN, SRBB: "Digital CARES workflow (CAD)" / "Straumann CARES Visual", consistent with predicate/reference.
Indications for Use Equivalence (with minor expansions/clarifications demonstrated via testing)	TLX Dental Implant: Broadly equivalent to predicates, with expansion to "multi-unit restorations" which is supported by testing. TLX Closure Caps/Healing Caps: Equivalent. TLX Temporary Abutment: Equivalent. TLX Variobase for Crown: Equivalent. TLX CARES Abutment TAN: Equivalent. TLX Screw-retained Bridges and Bars: Expanded to include "TLX implants", supported by device design and testing for new interface.

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Sizes: The document does not specify exact sample sizes for all performance tests (e.g., how many implants were used for dynamic fatigue testing, or how many software test cases were run). For dynamic fatigue, it mentions cycles (2 million, 200,000, 5 million, 500,000 cycles). For surface area and pull-out, it refers to "the Ø3.75 x 6 mm NT implants," but not a specific count.
Data Provenance: The document does not specify the country of origin for the test data, nor does it explicitly state if the testing was retrospective or prospective. Given it's premarket notification for a physical device, the "data" would primarily come from laboratory bench testing rather than patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable to this type of device submission. Ground truth established by experts (like radiologists) is relevant for AI/ML devices that interpret medical images or data. For this dental implant system, "ground truth" refers to the physical and mechanical properties of the device, which are established through standardized engineering and biocompatibility tests, not human expert consensus on clinical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable to this type of device submission. Adjudication methods are used in studies involving human interpretation (e.g., reading medical images) to resolve discrepancies and establish a consensus ground truth, typically for AI/ML performance evaluation. This document describes physical device testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This question is not applicable to this type of device submission. MRMC studies are specifically designed to evaluate the impact of AI on human reader performance in diagnostic tasks. This is a physical dental implant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable to this type of device submission. Standalone performance refers to the accuracy of an AI algorithm on its own. This is a physical dental implant, not an algorithm. (Note: Some CAD/CAM software is mentioned, but "standalone performance" in the AI context isn't relevant here; rather, the software's functionality and output are validated against engineering standards.)

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For this physical device, the "ground truth" for the performance claims comes from standardized laboratory testing and engineering measurements in controlled environments (e.g., dynamic fatigue machines, material analysis instruments, biological assays). There is no "expert consensus," "pathology," or "outcomes data" used as ground truth for the technical equivalence claims presented in the 510(k). The clinical indications are based on established dental practice and the equivalence to predicate devices which have a history of clinical use.

8. The sample size for the training set

This question is not applicable to this type of device submission. "Training set" refers to data used to train an AI/ML algorithm. This document does not describe an AI/ML component.

9. How the ground truth for the training set was established

This question is not applicable to this type of device submission as there is no AI/ML training set.

Summary

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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.

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

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Indications for Use

510(k) Number (if known) K200586

Device Name Straumann TLX Implant System

Indications for Use (Describe)

TLX Dental Implant:

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.

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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)60 Minuteman RoadAndover, MA 01810
Registration No.:	1222315	Owner/Operator No.:	9005052
	On the behalf of:Institut Straumann AGPeter Merian weg 124052 Basel, Switzerland
Contact Person:	Jennifer M. Jackson, MSDirector of Regulatory AffairsPhone Number: +1-978-747-2509Fax Number: +1-978-747-0023
Prepared By:	Renate ReissRegulatory Affairs and Compliance ManagerInstitut Straumann AGPhone number: +41 61 965 1260
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 – DZESecondary product code – NHA

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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.

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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

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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.

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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.

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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:

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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. .

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Straumann® TLX Implant System

Substantial Equivalence Discussion

	Proposed Device	Primary PredicateDevice	Reference Device	Reference Device	Reference Device	Reference Device
Feature	K200586Straumann TLX ImplantSystem	K173961Straumann BLXImplant System	K181703Straumann® BLXLine Extension	K171784Straumann Dentalimplant system	K150938Roxolid SLA Implants	K163194Neodent ImplantSystem - GM Line
Indications forUse	Straumann TLX Implantsare suitable for endostealimplantation in the upperand lower jaws and forthe functional andesthetic oral rehabilitationof edentulous andpartially edentulouspatients. TLX Implantscan be placed withimmediate function onsingle-tooth and multi-unitrestorations when goodprimary stability isachieved and withappropriate occlusalloading to restorechewing function. Theprosthetic restorations areconnected to the implantsthrough thecorresponding abutmentcomponents.	Straumann® BLXImplants are suitable forendosteal implantationin the upper and lowerjaw and for thefunctional and estheticoral rehabilitation ofedentulous and partiallyedentulous patients.BLX Implants can beplaced with immediatefunction on single-toothapplications when goodprimary stability isachieved and withappropriate occlusalloading to restorechewing function. Theprosthetic restorationsare connected to theimplants through thecorresponding abutmentcomponents.	Straumann® BLXImplants are suitablefor endostealimplantation in theupper and lower jawand for the functionaland esthetic oralrehabilitation ofedentulous andpartially edentulouspatients. BLX Implantscan be placed withimmediate function onsingle-tooth, bar andbridge applicationswhen good primarystability is achievedand with appropriateocclusal loading torestore chewingfunction. Theprosthetic restorationsare connected to theimplants through thecorrespondingabutment components.	Straumann® Dentalimplants are indicated fororal endostealimplantation in the upperand lower jaw arches andfor the functional andaesthetic oralrehabilitation ofedentulous and partiallydentate patients.Straumann® Dentalimplants are alsoindicated for immediate orearly implantationfollowing extraction or lossof natural teeth. Implantscan be placed withimmediate function onsingle-tooth and/ormultiple-tooth applicationswhen good primarystability is achieved andwith appropriate occlusalloading to restore chewingfunction. The prostheticrestorations used aresingle crowns, bridgesand partial or fulldentures, which areconnected to the implantsthrough the correspondingcomponents (abutments).	Straumann® Dentalimplants are indicated fororal endostealimplantation in the upperand lower jaw arches andfor the functional andaesthetic oralrehabilitation ofedentulous and partiallydentate patients.Straumann® Dentalimplants are alsoindicated for immediate orearly implantationfollowing extraction orloss of natural teeth.Implants can be placedwith immediate functionon single-tooth and/ormultiple-tooth applicationswhen good primarystability is achieved andwith appropriate occlusalloading to restorechewing function. Theprosthetic restorationsused are single crowns,bridges and partial or fulldentures, which areconnected to the implantsthrough thecorrespondingcomponents (abutments).	The Neodent ImplantSystem is intended to besurgically placed in thebone of the upper orlower jaw to providesupport for prostheticdevices such as artificialteeth, to restore chewingfunction. It may be usedwith single-stage or two-stage procedures, forsingle or multiple unitrestorations, and may beloaded immediatelywhen good primarystability is achieved andwith appropriate occlusalloading.
Material	Titanium-13 Zirconiumalloy (Roxolid®)	Titanium-13 Zirconiumalloy (Roxolid®)	Titanium-13 Zirconiumalloy (Roxolid®)	Titanium-13 Zirconiumalloy(Roxolid®)	Titanium-13 Zirconiumalloy(Roxolid®)	Titanium grade 4
	Proposed Device	Primary PredicateDevice	Reference Device	Reference Device	Reference Device	Reference Device
Feature	K200586Straumann TLX ImplantSystem	K173961Straumann BLXImplant System	K181703Straumann® BLXLine Extension	K171784Straumann Dentalimplant system	K150938Roxolid SLA Implants	K163194Neodent ImplantSystem - GM Line
SurfaceTreatment	Hydrophilic SLActive®	Hydrophilic SLActive®	Hydrophilic SLActive®	Hydrophilic SLActive®	SLA	NeoporosAcqua
Implant toAbutmentConnection	TorcFit(with conical fitting)	TorcFit(with conical fitting)	TorcFit(with conical fitting)	Narrow CrossFit (NC)Regular CrossFit (RC)Regular Neck (RN)Wide Neck (WN)	Narrow CrossFit (NC)Regular CrossFit (RC)Narrow Neck CrossFit(NNC)Regular Neck (RN)Wide Neck (WN)	GM interface; 16° Morsetaper with anti-rotationalfeatures.
ImplantDiameter	Ø3.75, 4.0, 4.5, 5.0, 5.5,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:6, 8, 10, 12, 14, 16 and18 mmØ5.5 and 6.5 mm: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 bonelevel tapered (BLT)	Parallel wall and bonelevel tapered (BLT)	TitamaxHelixDrive
Implant neck	Tulip shape	n/a (bone level)	n/a (bone level)	Tulip shapen/a (bone level)	Tulip shapen/a (bone level)	n/a (bone level)
Prostheticplatforms	NT, RT, and WT	RB and WB	RB and WB	RN, WN, RC, and NC	NC, RC, NNC, RN, andWN	GM interface
Thread Pitch	1.7, 2.0, 2.1, 2.2, 2.5, 2.6,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	TitamaxHelixDrive
SterilizationMethod	Irradiation	Irradiation	Irradiation	Irradiation	Irradiation	Irradiation

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Straumann® TLX Implant System

Substantial Equivalence Discussion

Table 1 – Comparison of subject device versus primary predicate device - TLX Dental Implant

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Straumann® TLX Implant System

Substantial Equivalence Discussion

Feature	Proposed DeviceK200586	Primary Predicate DeviceK173961
Indications for Use	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.	Straumann® Closure Caps and Healing Abutments 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 shape, maintain and stabilize the soft tissue during the healing process. Closure caps and healing abutments should be used only with suitable implant connections. Straumann Closure Caps and Healing Abutments have a maximum duration of usage of 6 months.
Material	Titanium Grade 4	Titanium Grade 4
Surface	No treatment	Anodized
Implant to AbutmentConnection	NT, RT, and WT	RB/WB and WB
Diameter or MinorOval Dimension/Major OvalDimension	Closure caps:Ø2.7, 4.0, and 5.5 mmHealing caps:Ø4.0, 5.5, and 7.2 mm	Closure caps:Ø3.4 and 4.5 mmHealing abutments:Ø4.0, 5.0, 6.0, 6.5, and 7.5 mm
Overall Length	Closure caps:4.4, 5.2, and 5.4 mmHealing caps:5.5 to 8.2 mm	Closure caps:4.6 and 4.7 mmHealing abutments:6.8 to 11.9 mm
Gingival Heights	Closure caps:0.5 and 1.5 mmHealing abutments:2.0, 3.0 and 4.5 mm	Closure caps:0.4 and 0.5 mmHealing abutments:1.5 to 3.5 mm
Sterilization Method	Irradiation	Irradiation

Table 2 – Comparison of subject device versus reference predicate device - TLX Closure Caps and

Healing Caps

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Straumann® TLX Implant System

Substantial Equivalence Discussion

	Proposed Device	Primary Predicate Device
Feature	K200586	K173961
Indications for Use	TLX Temporary Abutments can be used prior to theinsertion of the final components to maintain,stabilize and shape the soft tissue during thehealing phase; they may not be placed intoocclusion.TLX Temporary Abutments have a maximumduration of usage of 180 days.	Straumann® BLX Basal Screws andTemporary AbutmentsProsthetic components directly or indirectlyconnected to the endosseous dental implantare intended for use as an aid in prostheticrehabilitations. Temporary components can beused prior to the insertion of the finalcomponents to maintain, stabilize and shapethe soft tissue during the healing phase; theymay not be placed into occlusion. Finalabutments may be placed into occlusion whenthe implant is fully osseointegrated.BLX Temporary Abutments have a maximumduration of usage of 180 days.
Material	Ti-6Al-7Nb	Ti-6Al-7Nb
Implant to AbutmentConnection	TorcFit	TorcFit
Implant to AbutmentConnection	NT, RT & WT	RB/WB & WB
Diameter abutment	Ø3.90, 5.05, and 7.00 mm	Ø3.8, 4.5, 5.5 and 6 mm
Gingival Heights	n/a	0.75, 1.5, 2.5 and 3.5 mm
Chimney Heights	10 mm	10 mm
Sterilization Method	Non-sterile/End user sterilized	Non-sterile/End user sterilized
Surface	No treatment	Anodized
	Proposed Device	Primary Predicate Device	Reference Device
Feature	K200586	K173961	K190082
Indications forUse	Straumann® Variobase®prosthetic components directlyconnected to the endosseousdental implant are in-tended foruse as an aid in prostheticrehabilitations. The prostheticrestoration (crowns) can becemented onto the Straumann®Variobase® prostheticcomponents. A temporaryrestoration can be used prior tothe insertion of the finalcomponents to maintain,stabilize and shape the softtissue during the healing phase;they must be placed out ofocclusion. Final abutments andrestorations may be placed intoocclusion when the implant isfully osseointegrated. All digitallydesigned copings and/or crownsfor use with the Straumann®Variobase® Abutment system areintended to be sent toStraumann for manufacture at avalidated milling center.	Straumann® Variobase®prosthetic components directly orindirectly connected to theendosseous dental implant areintended for use as an aid inprosthetic rehabilitations. Theprosthetic restoration (crowns)can be cemented onto theStraumann® Variobase®prosthetic components. Atemporary restoration can beused prior to the insertion of thefinal components to maintain,stabilize and shape the softtissue during the healing phase;they must be placed out ofocclusion. Final abutments andrestorations may be placed intoocclusion when the implant isfully osseointegrated. All digitallydesigned copings and/or crownsfor use with the Straumann®Variobase® Abutment system areintended to be sent toStraumann for manufacture at avalidated milling center.	Straumann® Variobase®prosthetic components directly orindirectly connected to theendosseous dental implant areintended for use as an aid inprosthetic rehabilitations. Theprosthetic restoration (crowns)can be cemented onto theStraumann® Variobase®prosthetic components. Atemporary restoration can beused prior to the insertion of thefinal components to maintain,stabilize and shape the softtissue during the healing phase.They must be placed out ofocclusion. Final abutments andrestorations may be placed intoocclusion when the implant isfully osseointegrated. All digitallydesigned copings and/or crownsfor use with the Straumann®Variobase® Abutment system areintended to be sent toStraumann for manufacture at avalidated milling center.
Material	TAN (Titanium-Aluminum-Niobium alloy/Ti-6Al-7Nb)	TAN (Titanium-Aluminum-Niobium alloy/Ti-6Al-7Nb)	TAN (Titanium-Aluminum-Niobium alloy/Ti-6Al-7Nb)
Implant toAbutmentConnection	TorcFit	TorcFit	TorcFit
Implant toAbutmentConnection	NT, RT, and WT	RB/WB and WB	RB/WB and WB
ProstheticPlatform DiameterØ (mm)	4.0 (NT), 5.0 (RT) and 7.0 (WT)	3.8 (RB/WB), 4.5 (RB/WB), and5.5 (WB)	3.8 (RB/WB), 4.5 (RB/WB), and5.5 (WB)
AbutmentChimneyHeights(mm)	5.5 (NT), 6.0 (RT) and 6.5 (WT)can be reduced by up to 2 mmuntil5.5 (NT)→3.56.0 (RT) →4.0and 6.5 (WT) →4.5	5.5 mm (can be reduced up to 2mm until 3.5mm)	5.5 mm (can be reduced up to3.5 mm)
Digital Coping/Crown MaterialandCAD designlimits: Minimumwall thickness(mm)	Final restorationszerion® LT: 0.4zerion® ML: 0.4zerion® UTML: 0.5IPS e.max CAD:0.7Coron®: 0.3Temporary restorationpolycon® ae: 0.7	Final restorationsIPS e. max CAD:0.7Temporary restorationPolycon ® ae: 0.5	Final restorationscoron®: 0.3zerion® LT: 0.4zerion®ML: 0.4zerion® UTML: 0.5
CAD designlimits:Coping crownangulation	Up to 30°	Up to 30°	Up to 30°
	Proposed Device	Primary Predicate Device	Reference Device
Feature	K200586	K173961	K190082
MinimumAbutment PostHeight (after two-piece abutmentassembly)	4.0 mm	4.0 mm	4.0 mm
Design Workflow	Digital CARES workflow (CAD)	Wax-up or Straumann CARES®Visual, Dental Wings softwareusing the Straumann CARESVisual Plug-In and 3Shape	Wax-up or Straumann CARES®Visual, Dental Wings softwareusing the Straumann CARESVisual Plug-In and 3Shape
ManufacturingWorkflow	Straumann Milling	Straumann Milling	Straumann Milling
SterilizationMethod	Non-sterile/End user sterilized	Non-sterile/End user sterilized	Non-sterile/End user sterilized
Surface	Not anodized	Partially anodized	Partially anodized
Mode of Action	Screw-retained or cementretained	Screw-retained or cementretained	Screw-retained or cementretained

Table 3 – Comparison of subject device versus reference predicate device – TLX Temporary

Abutment

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Straumann® TLX Implant System

Substantial Equivalence Discussion

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Straumann® TLX Implant System

Substantial Equivalence Discussion

Table 4 – Comparison of subject device versus reference predicate device – TLX Variobase for

Crown

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Straumann® TLX Implant System

Substantial Equivalence Discussion

	Proposed Device	Reference Device	Reference Device
Feature	K200586	K190040	K172798
Indications forUse	Straumann® CARES® AbutmentsTAN are indicated for single-tooth replacements and multiple-tooth restorations. The prostheticrestoration can be cement-retained.	The Straumann CARESAbutments are indicated for singletooth replacement and multipletooth restorations. The prostheticrestoration can be cemented ordirectly veneered/Screw-retained.	The Straumann® CARES®Abutments CoCr are indicatedfor single tooth replacementand multiple tooth restorations.The prosthetic restoration canbe cemented or directlyveneered/screw-retained.
Material	TAN	TANCoCr	CoCr
Implant toAbutmentConnection	TorcFit	TorcFit	synOcta and CrossFit
Implant toAbutmentConnection	NT, RT, and WT	RB/WB and WB	RN, WN, NC, and RC
Type ofrecommendedrestoration	Crowns and bridges	Crowns and bridges	Crowns and bridges
Design workflow	Digital CARES workflow (CAD)	Wax-up or Straumann CARESVisual, Dental Wings softwareusing the Straumann CARESVisual Plug-In	Digital CARES workflow (CAD)
Manufacturingworkflow	Digital CARES workflow viaStraumann milling center	Digital workflow via Straumannmilling center	Digital CARES workflow viaStraumann milling center
CAD designlimits:Coping/crownangulation	Up to 30°	Up to 30°	Up to 30°
CAD designlimits: Minimumwall thickness(mm)	0.33	0.33	0.33
CAD designlimits: Minimumabutment postheight (mm)	4 mm	N/A	N/A
Sterilizationmethod	Non-sterile/End user sterilized(steam autoclave)	Non-sterile/End user sterilized(steam autoclave)	Non-sterile/End user sterilized(steam autoclave)
Mode of action	Screw-retained	Screw-retained	Screw-retained
	Proposed Device	Reference Device
Feature	K200586	K190097
Indications for Use	Straumann® CARES® Screw-retainedBridges and Bars are indicated for use asbars and bridges that attach to implants toprovide support for prosthetic reconstructionssuch as bridges and overdentures. The finalprocessed products have the purpose ofrestoring chewing function. Straumann®CARES® Screw-retained Bridges and Barsare indicated for Screw-retained restorations.Straumann® CARES® Screw-retainedBridges and Bars are designed to interfacewith the Bone Level (BL), Tissue Level (TL),BLX implants and TLX implants of theStraumann Dental Implant System (SDIS).	Straumann® CARES® Screw-retainedBridges and Bars are indicated for use asbars and bridges that attach to implants toprovide support for prosthetic reconstructionssuch as bridges and overdentures. The finalprocessed products have the purpose ofrestoring chewing function. Straumann®CARES® Screw-retained Bridges and Barsare indicated for Screw-retained restorations.Straumann® CARES® Screw-retainedBridges and Bars are designed to interfacewith the Bone Level (BL), Tissue Level (TL),and BLX implants of the Straumann DentalImplant System (SDIS).
Material	SRBB Restoration:Cobalt Chrome Alloy (CoCr)Titanium Grade 4Screw:TAN (Titanium-Aluminum-Niobium alloy/Ti-6Al-7Nb)	Restorations:Cobalt Chrome Alloy (CoCr)Titanium Grade 4Screws:Titanium-Aluminum-Niobium alloy (Ti-6Al-7Nb)
Implant to SRBB Connection(interface)	Bone Level (BL) - external coneTissue Level (TL) - internal coneBLX - internal coneTLX - internal cone	Bone Level (BL) - external coneTissue Level (TL) - internal coneBLX - internal cone
SupportedStraumannInterfaces	Bone Level – RC, NCTissue Level – RN, WNBLX – RB, WBTLX – NT, RT, WT	Bone Level – RC, NCTissue Level – RN, WNBLX – RB, WB
RestorationTypesSupported	Bridges from 2 units to 16 units (full-arch)Bars from 2 units to 10 units	Bridges from 2 units to 16 units (full-arch)Bars from 2 units to 10 units
Design Workflow	Digital CARES workflow (CAD)	CAD
DesignSoftware	Straumann CARES Visual	Straumann CARES Visual
Manufacturing Workflow	Digital CARES workflow via Straumannmilling center	Digital CARES workflow via Straumannmilling center
Design Limitsfor Bridges	Critical geometry parameters are enforced byCARES Visual limits	Critical geometry parameters are enforced byCARES Visual limits
Design Limitsfor Bars	Critical geometry parameters are enforced byCARES Visual limits	Critical geometry parameters are enforced byCARES Visual limits
Sterilization method	Non-sterile/End user sterilized (steam autoclave)	Non-sterile/End user sterilized (steam autoclave)
Mode of Action	Screw-retained	Screw-retained

Table 5 – Comparison of subject device versus reference predicate device - TLX CARES Abutment

TAN

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Straumann® TLX Implant System

Substantial Equivalence Discussion

Table 6 – Comparison of subject device versus reference predicate device - TLX Screw-retained

Bridges and Bars (SRBB)

{19}------------------------------------------------

Straumann® TLX Implant System

Substantial Equivalence Discussion

Performance Testing 5.7 -

Bench Testing 5.7.1

Dynamic fatique tests were conducted according to the FDA quidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and demonstrated the TLX Dental Implant system is equivalent to the predicate and reference devices. The tests were conducted in both, saline (2 Hz and 37°C) and air (15 Hz). In saline at 2 million cycles for permanent and 200,000 cycles for temporary restorations. In air at 5 million cycles for permanent and 500,000 cycles for temporary restorations.

Surface area comparison and pull-out testing were performed on the Ø3.75 x 6 mm NT implants and were determined to have a larger endosseous surface area and higher pull-out force compared to the reference Ø4.1 x 6 mm device.

Biocompatibility Testing 5.7.2

Biological assessment has been performed according to ISO 10993-1:2009 "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" and to the FDA Guidance document "Use of International Standard ISO 10993- 1, 'Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process', Guidance for Industry and Food and Drug Administration Staff, Document issued on: June 16, 2016" for each of the subject devices. The subject device materials are identical to the predicate and reference device materials, therefore, no new issues regarding biocompatibility were raised.

Sterilization Validation and Packaging 5.7.3

The sterilization process for the TLX Dental Implant system as recommended in the labeling was validated according to:

For devices delivered sterile (TLX implants and Healing/Closure caps) - a sterility assurance level (SAL) of 10-6 had been validated in accordance with ISO 11137-1:2006, Sterilization of health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices, 2006-04-05. The validation method used

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Straumann® TLX Implant System

Substantial Equivalence Discussion

was the over kill bioburden method in accordance with ISO 11137-2:2013, Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose. The packaging of all TLX devices is equivalent to the packaging of the predicate and reference device. The shelf life for devices provided sterile is 5 years. The devices will not be marketed as non-pyrogenic. 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.

For devices delivered non-sterile to be end-user sterilized (TLX Temporary abutments, Variobase for Crown, CARES Abutment TAN and Screw-retained Bridges and Bars), The recommended sterilization has been validated according to ISO 17665-1 and ISO 17665-2 and to applicable recommendations in the FDA quidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015". There are no changes to the sterilization procedures or processes from those of the Straumann predicate devices.

Software Validation 5.7.4

Software validation testing were conducted and documentation was provided according to the FDA quidance documents "Class II Special Controls Guidance Document: Optical Impression Systems for Computer Assisted Design and Manufacturing (CAD/CAM) of Dental Restorations" and "General Principles of Software Validation; Final Guidance for Industry and FDA Staff". The software for this device was considered as a "moderate" level of concern.

5.8 Conclusion

The documentation submitted in this premarket notification demonstrates the Straumann TLX Implant System is substantially equivalent to the primary predicate and reference devices.

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.