(197 days)
TLX SRAs: Straumann® abutments are indicated to be placed into Straumann® dental implants to provide a support structure for the functional and esthetic oral rehabilitation of edentulous or partially edentulous patients with crowns, bridges, or full-arch prostheses.
TLX Gold Abutments: Straumann® abutments are indicated to be placed into Straumann® dental implants to provide a support structure for the functional and esthetic oral rehabilitation of edentulous or partially edentulous patients with crowns, bridges, or full-arch prostheses. Copings are indirectly connected to the endosseous dental implant and are indicated for use as an aid in prosthetic rehabilitations.
TLX SRAs: Straumann® TLX SRAs are intended to be placed on TLX Straumann dental implants to provide support for screw-retained single or multi-unit restorations. They are identical in design to the reference devices BLX SRAs cleared as per K181703, except for the laser marking and the anodization. The TLX SRAs have no anodization, but additional laser marking at the connection. The TLX SRAs are provided sterile by gamma radiation. The TLX SRAs are made of TAN (Ti-6Al-7Nb) and are available in angulations of 17° and 30°. The TLX SRAs are secured in the implant through a basal screw made of TAN. The SRAs are provided with a transfer piece (Pin).
TLX Gold Abutments: Straumann TLX Gold Abutments consist of a Ceramicor® alloy base, which is fixed to the implant by means of a basal screw made of Ti-6AI-7Nb, Titanium Aluminum Niobium (TAN). A modelling aid made of POM-C is attached onto the abutment by friction fit when delivered in the package. There are two versions of TLX Gold Abutments: one is for single crown restoration, and the other is for multiunit restoration such as bar or bridge. The TLX Gold Abutments for crown contain the TorcFit connection which provides the rotational indexation. On the other hand, the TLX Gold Abutments for bar/bridge do not have the TorcFit indexation feature since it is used in multiunit restorations. Both versions are available in three different platform diameters, NT (Narrow, TorcFit™), RT (Regular, TorcFit™) and WT (Wide, TorcFit™), allowing the abutments to sit on the shoulders of the corresponding TLX implants. The TLX Gold Abutments have a maximum angulation of 30°, a minimum post height of 4 mm, and a minimum wall thickness of 0.7 mm.
The provided text describes the acceptance criteria and the study that proves the device meets the acceptance criteria for dental implant abutments (TLX SRAs and TLX Gold Abutments).
Here's the breakdown of the information requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly met by demonstrating equivalence to predicate devices through performance testing. The reported device performance indicates successful completion of these tests without failure.
| Test Type | Acceptance Criteria (Implicit, based on equivalence) | Reported Device Performance |
|---|---|---|
| Dynamic Fatigue (Gold Abutments) | Conducted according to ISO 14801 and FDA guidance for endosseous dental implants and abutments. Acceptance of equivalence to primary predicate and reference devices, implying the ability to cover permanent restoration of the implant without failure. | The test for the Gold Abutments was conducted in saline (2 Hz and 37°C) at 2 million cycles, covering permanent restoration of the implant without failure. "demonstrated the subject TLX SRAs and Gold Abutments are equivalent to the primary predicate and reference devices." |
| Dynamic Fatigue (SRA Abutments) | Conducted according to ISO 14801 and FDA guidance for endosseous dental implants and abutments. Acceptance of equivalence to primary predicate and reference devices, implying the ability to cover permanent restoration of the implant without failure. | The test for the SRA Abutments was a pre-test conducted in ambient air (15 Hz and room temperature) at 5 million cycles, covering permanent restoration of the implant without failure. "demonstrated the subject TLX SRAs and Gold Abutments are equivalent to the primary predicate and reference devices." |
| Biocompatibility | Assessment according to ISO 10993-1 and FDA Guidance document "Use of International Standard ISO 10993-1...". Acceptance implies no new biocompatibility issues are raised compared to predicate devices. | A biological assessment was performed demonstrating "No new issues of biocompatibility are raised for the subject devices. Therefore, no additional biocompatibility testing was required." |
| Magnetic Resonance Compatibility | Equivalence to predicate devices (K181703), implying the applicability of previous MR Conditional wording. | "The reference devices K181703 and compatible prosthetics have obtained the status of MR Conditional. No new materials or worst-case constructs are introduced with the subject devices; thus, the previous MRI conditional wording is applicable." |
| Sterilization (TLX SRAs) | Sterility Assurance Level (SAL) of ≤ 10⁻⁶ in accordance with ISO 11137-1. Equivalent to reference devices K181703. | "The sterilization process for the subject TLX SRAs was validated to a sterility assurance level (SAL) of ≤ 10⁻⁶ in accordance with ISO 11137-1... The sterilization method and packaging of the subject TLX SRAs is identical to the reference devices K181703." |
| Shelf-life (TLX SRAs) | 5 years life. Equivalent to reference devices K181703. | "The shelf life for devices provided sterile is 5 years... The sterilization method and packaging of the subject TLX SRAs is identical to the reference devices K181703." |
| Pyrogenicity (TLX SRAs) | Meet pyrogen limit specifications of 20 EU/device, based on the LAL Endotoxin Analysis method (for blood contacting and implanted devices). | "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." |
| Sterilization (TLX Gold Abutments) | Sterility Assurance Level (SAL) of ≤10⁻³ using the biological indicator (BI) overkill method (for the product group, Implant Borne Prosthetics). Equivalent to reference devices K200597. | "These sterilization parameters have been validated to a sterility assurance level (SAL) of ≤10⁻³ using the biological indicator (BI) overkill method for the product group, Implant Borne Prosthetics. The subject TLX Gold Abutments do not introduce a new worst case compared to the reference devices K200597." |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify a "test set" in the context of clinical data or human subject studies. The testing described is primarily bench testing (dynamic fatigue) and assessments of material properties, biocompatibility, and sterilization validation. Therefore, there's no information about sample size for a test set of patient data, nor its provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. The described studies are not clinical trials involving expert interpretation of patient data to establish ground truth. They are bench tests and assessments against established engineering and biological standards.
4. Adjudication Method for the Test Set
Not applicable, as there is no "test set" in the context of clinical data requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This device is a dental implant abutment, not an AI-powered diagnostic or assistive tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical medical device (dental implant abutment), not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for the performance claims is based on:
- Established engineering standards: ISO 14801 for dynamic fatigue testing.
- Regulatory guidance documents: FDA guidance for endosseous dental implants and abutments.
- Biological safety standards: ISO 10993-1 and FDA guidance for biocompatibility.
- Sterilization validation standards: ISO 11137-1.
- Equivalence to legally marketed predicate and reference devices: The core of the 510(k) submission is to demonstrate substantial equivalence to previously cleared devices. The predicate and reference devices, having previously met regulatory requirements, serve as the benchmark for "ground truth" in terms of safety and effectiveness.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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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, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
4/8/2022
Institut Straumann AG % Jennifer Jackson Director, Regulatory Affairs Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810
Re: K213063
Trade/Device Name: TLX SRAs and TLX Gold Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: March 9, 2022 Received: March 11, 2022
Dear Jennifer Jackson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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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 Andrew Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K213063
Device Name TLX SRAs and TLX Gold Abutments
Indications for Use (Describe) TLX SRAs
Straumann® abutments are indicated to be placed into Straumann® dental implants to provide a support structure for the functional and esthetic oral rehabilitation of edentulous patients with crowns, bridges or full-arch prostheses.
TLX Gold Abutments
Straumann® abutments are indicated to be placed into Straumann® dental implants to provide a support structure for the functional and esthetic oral rehabilitation of edentulous patients with crowns, bridges or full-arch prostheses.
Copings are indirectly connected to the endosseous dental implant and are indicated for use as an aid in prosthetic rehabilitations.
| Type of Use (Select one or both, as applicable) | ||||||
|---|---|---|---|---|---|---|
| Residential Use (Part 9, OBC 9.36) Select One Day Care Centre Use (Part 9, OBC 9.36) Select One | Residential Use (Part 9, OBC 9.36) Select One | Residential Use (Part 9, OBC 9.36) Select One | Day Care Centre Use (Part 9, OBC 9.36) Select One | Day Care Centre Use (Part 9, OBC 9.36) Select One | ||
| Residential Use (Part 9, OBC 9.36) Select One | Residential Use (Part 9, OBC 9.36) Select One | Day Care Centre Use (Part 9, OBC 9.36) Select One | Day Care Centre Use (Part 9, OBC 9.36) Select One | |||
| Residential Use (Part 9, OBC 9.36) Select One | ||||||
| Day Care Centre Use (Part 9, OBC 9.36) Select One |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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TLX SRAs and TLX Gold Abutments
510(k) Summary
510(k) Summary
Submitter's Contact Information
| Submitter: | Straumann USA, LLC60 Minuteman RoadAndover, MA 01810Registration No.: 1222315 Owner/Operator No.: 9005052On the behalf of:Institut Straumann AGPeter Merian-Weg 124052 Basel, Switzerland |
|---|---|
| Contact Person: | Jennifer M. Jackson, MSDirector of Regulatory Affairs and QualityPhone Number: +1-978-747-2509Fax Number: +1-978-747-0023 |
| Prepared By &Alternate Contact: | Yu-Ting ChangInternational Regulatory Affairs ManagerInstitut Straumann AGPhone number: +41 61 965 1318 |
| Date of Submission: | April 8, 2022 |
Name of the Device
| Trade Names: | TLX SRAs and TLX Gold Abutments |
|---|---|
| Common Name: | Endosseous Dental Implant Abutments |
| Classification Name: | Endosseous Dental Implant Abutments |
| Regulation Number: | §872.3630 |
| Device Classification: | II |
| Product Code(s): | NHA |
| Classification Panel: | Dental |
| Proprietary Name: | TLX SRAs and TLX Gold Abutments |
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TLX SRAs and TLX Gold Abutments
510(k) Summary
Predicate Device(s)
Primary Predicate:
-
K203355 Straumann TLX Novaloc and Cementable Abutments Cementable . Abutments
Reference Devices: -
K181703 Straumann® BLX Line Extension Implants, SRAs, and Anatomic Abutments . - SRAs
-
K200597 BLX Gold Abutments .
Device Description
TLX SRAs
Straumann® TLX SRAs are intended to be placed on TLX Straumann dental implants to provide support for screw-retained single or multi-unit restorations. They are identical in design to the reference devices BLX SRAs cleared as per K181703, except for the laser marking and the anodization. The TLX SRAs have no anodization, but additional laser marking at the connection. The TLX SRAs are provided sterile by gamma radiation. The TLX SRAs are made of TAN (Ti-6Al-7Nb) and are available in angulations of 17° and 30°. The TLX SRAs are secured in the implant through a basal screw made of TAN. The SRAs are provided with a transfer piece (Pin).
TLX Gold Abutments
Straumann TLX Gold Abutments consist of a Ceramicor® alloy base, which is fixed to the implant by means of a basal screw made of Ti-6AI-7Nb, Titanium Aluminum Niobium (TAN). A modelling aid made of POM-C is attached onto the abutment by friction fit when delivered in the package. There are two versions of TLX Gold Abutments: one is for single crown restoration, and the other is for multiunit restoration such as bar or bridge. The TLX Gold Abutments for crown contain the TorcFit connection which provides the rotational indexation. On the other hand, the TLX Gold Abutments for bar/bridge do not have the TorcFit indexation feature since it is used in multiunit restorations. Both versions are available in three different platform diameters, NT (Narrow, TorcFit™), RT (Regular, TorcFit™) and WT (Wide, TorcFit™), allowing the abutments to sit on the shoulders of the corresponding TLX implants. The TLX Gold
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TLX SRAs and TLX Gold Abutments
510(k) Summary
Abutments have a maximum angulation of 30°, a minimum post height of 4 mm, and a minimum wall thickness of 0.7 mm.
Intended Use
TLX SRAs
Straumann® implants and abutments are intended for use in oral implantation to provide a support structure for connected prosthetic devices.
TLX Gold Abutments
Straumann® dental implants and abutments are intended for oral implantation to provide a support structure for connected prosthetic devices.
Copings are indirectly connected to the endosseous dental implant and are indicated for use as an aid in prosthetic rehabilitations.
Indications for Use
TLX SRAs
Straumann® abutments are indicated to be placed into Straumann® dental implants to provide a support structure for the functional and esthetic oral rehabilitation of edentulous or partially edentulous patients with crowns, bridges, or full-arch prostheses.
TLX Gold Abutments
Straumann® abutments are indicated to be placed into Straumann® dental implants to provide a support structure for the functional and esthetic oral rehabilitation of edentulous or partially edentulous patients with crowns, bridges, or full-arch prostheses.
Copings are indirectly connected to the endosseous dental implant and are indicated for use as an aid in prosthetic rehabilitations.
Technological Characteristics
The technological characteristics of the subject devices are compared to the primary predicate and reference devices in the following tables:
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TLX SRAs and TLX Gold Abutments
510(k) Summary
TLX SRAs
| FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | EQUIVALENCE DISCUSSION |
|---|---|---|---|---|
| K Number | K213063Straumann TLX SRAs | K203355Straumann TLX CementableAbutments | K181703Straumann BLX SRAs | |
| Indicationsfor Use | Straumann® abutments areindicated to be placed intoStraumann® dental implants toprovide a support structure forthe functional and esthetic oralrehabilitation of edentulous orpartially edentulous patients withcrowns, bridges, or full-archprostheses. | Prosthetic components directlyconnected to the endosseousdental implant are intended foruse as an aid in prostheticrehabilitations. Final abutmentsmay be placed into occlusion forimplants with sufficient primarystability and with appropriateocclusal loading to restorechewing function or for implantsthat are fully osseointegrated | Prosthetic components directlyor indirectly connected to theendosseous dental implant areintended for use as an aid inprosthetic rehabilitations.Temporary components can beused prior to the insertion of thefinal components to maintain,stabilize and shape the softtissue during the healing phase;they may not be placed intoocclusion. Final abutments maybe placed into occlusion whenthe implant is fullyosseointegrated. BLX TemporaryAbutments have a maximumduration of usage of 180 days. | Equivalent.All allow the abutment to beplace/connected to dentalimplants and the purpose is toaid/support the prostheticrehabilitation.The subject device providesmore detail regarding the type ofrehabilitation These are alsoimplicitly covered under primarypredicate and reference device.The final abutment placementrecommendation of the subjectdevice was moved from theIndications for Use Statement tothe Caution/Precautions sectionof the Instructions for Use sincethe loading of the implant body isinherent to the Indications forUse of the overarching implantbody clearance.Therefore, the scope is the sameamong subject, primarypredicate, and referencedevices. |
| Material | Ti-6Al-7Nb (TAN) | Ti-6Al-7Nb (TAN) | Ti-6Al-7Nb (TAN) | Identical |
| Implant toAbutmentConnection | TLX TorcFit | TLX TorcFit | BLX TorcFit | IdenticalIdentical to the primary predicatedevice. |
| FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | EQUIVALENCE DISCUSSION |
| K Number | K213063Straumann TLX SRAs | K203355Straumann TLX CementableAbutments | K181703Straumann BLX SRAs | |
| PlatformDiameter | Ø4.6 mm | 4.0 (NT), 5.0 (RT) and 7.0 (WT) | Ø4.6 mm | IdenticalIdentical to the reference device |
| Platform | NT | NT, RT, and WT | RB/WB | IdenticalIdentical to the primary predicatedevice. |
| Heights | 3.5 mm | Straight: 5,7 and 6 mmAngled: 6 mm | 1.5, 2.5, 3.5 and 4.5 mm | IdenticalIdentical to the reference device |
| Angulation | 17° and 30° | 0° and 15 | 0°, 17° and 30° | IdenticalIdentical to the reference device |
| SterilizationMethod | Sterile by gamma radiation | Non-sterile | Sterile by gamma radiation | IdenticalIdentical to the reference device |
| Prosthesistype | Screw-retained | Cemented-retained | Screw-retained | IdenticalIdentical to the reference device |
| Surface | Not anodized | Not anodized | Anodized | IdenticalIdentical to the primary predicatedevice. |
| Shelf life | 5 years | Without defined shelf life | 5 years | IdenticalIdentical to the reference device |
| Packaging | Sterile barrier system (blister)protected by folding box | Non-sterile blister | Sterile barrier system (blister)protected by folding box | IdenticalIdentical to the reference device |
| FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | EQUIVALENCE DISCUSSION |
| K Number | K213063Straumann TLX GoldAbutments | K203355Straumann TLX CementableAbutments | K200597BLX Gold Abutments | |
| Indicationsfor Use | Straumann® abutments areindicated to be placed intoStraumann® dental implants toprovide a support structure forthe functional and esthetic oralrehabilitation of edentulous orpartially edentulous patients withcrowns, bridges or full-archprostheses.Copings are indirectly connectedto the endosseous dental implantand are indicated for use as anaid in prosthetic rehabilitations. | Prosthetic components directlyconnected to the endosseousdental implant are intended foruse as an aid in prostheticrehabilitations. Final abutmentsmay be placed into occlusion forimplants with sufficient primarystability and with appropriateocclusal loading to restorechewing function or for implantsthat are fully osseointegrated | Straumann abutments areintended to be placed intoStraumann dental implants toprovide support for prostheticreconstructions such as crowns,bridges, and overdentures. | Equivalent.All allow the abutment to beplaced/connected to dentalimplants for the purpose ofaiding/supporting the prostheticrehabilitation.The subject device Indicationsfor Use provides more detailconcerning the rehabilitation. Theindications are also coveredunder the primary predicate andreference devices Indications forUse.The final abutment placementrecommendation for the subjectdevices was moved from theIndications for Use Statement tothe Caution/Precautions sectionof the Instructions for Use sincethe loading of the implant body isinherent to the Indications forUse of the overarching implantbody clearance.The scope of the Indications forUse is the same among subject,primary predicate, and referencedevices. |
| Material | Ceramicor® (base)TAN (screw)POM (modeling aid) | Ti-6Al-7Nb (TAN) | Ceramicor® (base)TAN (screw)POM (modeling aid) | IdenticalIdentical to the reference device. |
| FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | EQUIVALENCE DISCUSSION |
| K Number | K213063Straumann TLX GoldAbutments | K203355Straumann TLX CementableAbutments | K200597BLX Gold Abutments | |
| AbutmentShape inCoronalPortion | Axial screw access hole forplacement of abutment intoimplant | Axial screw access hole forplacement of abutment intoimplant | Axial screw access hole forplacement of abutment intoimplant | IdenticalIdentical to the primary predicateand reference device. |
| Abutment toImplantConnection | TLX TorcFit | TLX TorcFit | BLX TorcFit | IdenticalIdentical to the primary predicatedevice. |
| PlatformDiameter(mm) | 4.0 (NT), 5.0 (RT) and 7.0 (WT) | 4.0 (NT), 5.0 (RT) and 7.0 (WT) | RB/WB: 3.8 and 4.5WB: 4.5 and 5.5 | IdenticalIdentical to the primary predicatedevice. |
| Post Heightof StockComponent | NT (3 mm), RT (3.6 mm) and WT(4 mm) | Straight: 5.7 and 6 mmAngled: 6 mm | RW/WB and WB: 2.6 mm | EquivalentThe post heights are equivalentto the reference device. In bothcases, the post provides theinitial support for casting. |
| Wallthickness | 0.7* | n/a | 0.7* | IdenticalSubject device and referencedevice have a minimumrecommended wall thickness of0.7mm, as described in the IFU |
| Angulation | 0° and up to 30** aftercustomization | 0° and 15° | 0° and up to 30** aftercustomization | IdenticalIdentical to the reference device. |
| RestorationType | Crown, Bridge and Full Arch | Crown, Bridge and Full Arch | Crown, Bridge and Full Arch | IdenticalIdentical to the primary predicatedevice. |
| SterilizationMethod | Non-sterile/End user sterilized | Non-sterile/End user sterilized | Non-sterile/End user sterilized | IdenticalIdentical to the primary predicatedevice. |
| FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | EQUIVALENCE DISCUSSION |
| K Number | K213063Straumann TLX GoldAbutments | K203355Straumann TLX CementableAbutments | K200597BLX Gold Abutments | |
| Surface | Not anodized | Not anodized | Not anodized | IdenticalIdentical to the primary predicatedevice. |
| RestorationType | Cemented or screw-retained | Cemented-retained | Cemented or screw-retained | IdenticalIdentical to the reference device. |
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TLX SRAs and TLX Gold Abutments
510(k) Summary
Table 1 – Comparison of subject device versus primary predicate and reference device (SRAs)
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TLX SRAs and TLX Gold Abutments
510(k) Summary
TLX Gold Abutments
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TLX SRAs and TLX Gold Abutments
510(k) Summary
{10}------------------------------------------------
TLX SRAs and TLX Gold Abutments
510(k) Summary
*Given by the wall thickness upon casting
**Abutments are provided straight (i.e., 0°) but may have an angulation of up to 30° upon casting
Table 2 – Comparison of subject device versus primary predicate and reference device (Gold Abutments)
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TLX SRAs and TLX Gold Abutments
510(k) Summary
Performance Testing
Bench Testing
An assessment regarding dynamic fatigue testing was conducted according to ISO 14801, Dentistry – Implants – Dynamic fatigue test for endosseous dental implants and the FDA guidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and demonstrated the subject TLX SRAs and Gold Abutments are equivalent to the primary predicate and reference devices.
The test for the Gold Abutments was conducted in saline (2 Hz and 37°C) at 2 million cycles covering permanent restoration of the implant without failure. The test for the SRA Abutments was a pre-test conducted in ambient air (15 Hz and room temperature) at 5 million cycles covering permanent restoration of the implant without failure.
Biocompatibility Testing
A biological assessment was performed according to ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process and to the FDA Guidance document Use of International Standard ISO 10993- 1, 'Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process', Guidance for Industry and Food and Drug Administration Staff, Document issued on: June 16, 2016. No new issues of biocompatibility are raised for the subject devices. Therefore, no additional biocompatibility testing was required.
Magnetic Resonance Compatibility
The reference devices K181703 and compatible prosthetics have obtained the status of MR Conditional. No new materials or worst-case constructs are introduced with the subject devices; thus, the previous MRI conditional wording is applicable.
Sterilization, Shelf-life, and Package
SRAs
The subject TLX SRAs are single patient devices and are provided sterile. The sterilization process for the subject TLX SRAs was validated to a sterility assurance level (SAL) of ≤ 10ª in accordance with ISO 11137-1, Sterilization of health care products - Radiation - Part 1:
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TLX SRAs and TLX Gold Abutments
510(k) Summary
Requirements for development, validation, and routine control of a sterilization process for medical devices.
The shelf life for devices provided sterile is 5 years. The sterilization method and packaging of the subject TLX SRAs is identical to the reference devices K181703.
The subject devices will not be marketed as non-pyrogenicity information provided is based on FDA Guidance on Submission and Review of Sterility Information in Premarket Notification (510(k)) Submission for Devices Labeled as Sterile, issued on 21 January 2016. The method used to determine the device meets pyrogen limit specifications is LAL Endotoxin Analysis with testing limit of 20 EU/device, based on a blood contacting and implanted device.
Gold Abutments
The TLX Gold Abutments are single patient devices and are provided non-sterile. The sterilization procedures reflect the FDA guidance document, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff, Document issued on: March 17, 2015".
These sterilization parameters have been validated to a sterility assurance level (SAL) of ≤10° using the biological indicator (BI) overkill method for the product group, Implant Borne Prosthetics. The subject TLX Gold Abutments do not introduce a new worst case compared to the reference devices K200597.
Conclusion
The documentation submitted in this premarket notification demonstrates the subject TLX SRAs and Gold Abutments are substantially equivalent to the primary predicate devices.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)