(88 days)
TLX Novaloc Abutments: The Straumann® Retentive System is indicated for the attachment of full or partial dentures on Straumann dental implants (NT, RT, and WT).
TLX Cementable Abutments: Prosthetic components directly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations. Final abutments may be placed into occlusion for implants with sufficient primary stability and with appropriate occlusal loading to restore chewing function or for implants that are fully osseointegrated.
Straumann TLX Novaloc Abutments: The subject TLX Novaloc Abutments are intended to be placed onto Straumann TLX implants to provide support for full arch detachable restorations (over-denture). The coronal portion of the subject abutments is similar to the primary predicate devices, whereas the apical portion of the abutments has the appropriate implant-to-abutment interface geometry for each of the platforms of the Straumann TLX Implant System (NT, RT and WT). The Novaloc Abutments are manufactured from TAV (Ti-6Al-4V, Titanium-Aluminum-Vanadium). The restoration is connected to the Novaloc Abutment through a snap-on fixture provided by a negative shape of Novaloc snapon fixture embedded into the final restoration. The snap-on feature is TiN coated. The subject TLX Novaloc Abutments are provided in straight and angulated versions, in different heights. The TLX Novaloc Abutments are provided non-sterile with instructions for end user sterilization.
Straumann TLX Cementable Abutments: The subject TLX Cementable Abutments are intended to provide support for prosthetic reconstructions such as crowns and bridges and are used with cemented restorations. They are made of titanium alloy (Ti-6Al-7Nb or TAN) and are attached to the implant with a basal screw. To allow for more flexibility they are offered in a straight and in an angulated version for each of the three platforms (NT, RT and WT). The TLX Cementable Abutments are provided non-sterile with instructions for end user sterilization.
The provided text describes the regulatory clearance of a medical device (Straumann TLX Novaloc and Cementable Abutments) and includes a summary of performance testing. However, it does not contain the specific information required to complete numbers 2, 3, 4, 5, 6, 7, 8, and 9 of your request. These details are typically associated with clinical studies and AI performance evaluations, which are not the focus of this 510(k) summary.
Here's the information that can be extracted and a note on the missing information:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for this device are based on demonstrating equivalence to predicate devices through various performance tests. The specific numerical acceptance criteria (e.g., minimum breaking strength or fatigue cycles) are not explicitly stated as numerical values in this summary but are referenced against established standards and guidance documents.
| Acceptance Criterion (Based on Standards and Guidance) | Reported Device Performance |
|---|---|
| Dynamic fatigue testing (according to ISO 14801 and FDA Guidance) | Demonstrated equivalence to primary predicate and reference devices. |
| Static strength testing (according to ISO 14801 and FDA Guidance) | Demonstrated equivalence to primary predicate and reference devices. |
| Biocompatibility (according to ISO 10993-1 and FDA Guidance) | Found equivalent to primary predicate and reference devices, raising no new issues. |
| Sterilization validation (according to ISO 17665-1, ISO 17665-2, and FDA Guidance) | Validated the recommended moist heat (steam) end-user sterilization method; no changes from predicate. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. The testing described is bench testing, not a clinical study with human subjects, so concepts like "test set" in the context of clinical data are not applicable here.
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 information is not provided as the submission focuses on bench testing for mechanical and biological equivalence, not expert-adjudicated clinical performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this was bench 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
Not applicable. This device is a dental abutment, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a dental abutment, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For mechanical and biocompatibility testing, the "ground truth" refers to established scientific principles, standards (ISO 14801, ISO 10993-1, ISO 17665-1, ISO 17665-2), and FDA guidance documents. There is no biological "ground truth" derived from patient outcomes or expert consensus in the context of this 510(k) summary.
8. The sample size for the training set
Not applicable. This device is a physical product, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
Institut Straumann AG % Jennifer Jackson Director, Regulatory Affairs Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01801
Re: K203355
Trade/Device Name: Straumann TLX Novaloc and Cementable Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: November 12, 2020 Received: November 16, 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 (OS) 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.
Andrew Steen Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K203355
Device Name:
Straumann TLX Novaloc and Cementable Abutments
Indications for Use (Describe)
TLX Novaloc Abutments
The Straumann® Retentive System is indicated for the attachment of full or partial dentures on Straumann dental implants (NT, RT, and WT).
TLX Cementable Abutments
Prosthetic components directly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations. Final abutments may be placed into occlusion for implants with sufficient primary stability and with appropriate occlusal loading to restore chewing function or for implants that are fully osseointegrated.
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)
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FORM FDA 3881 (7/17)
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Straumann TLX Novaloc and Cementable Abutments
510(k) Summary
5 510(k) Summary
5.1 Submitter's Contact Information
| Submitter: | Straumann USA, LLC60 Minuteman RoadAndover, MA 01810Registration 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 &Alternate Contact: | Laure KuhnerRegulatory Affairs SpecialistInstitut Straumann AGPhone Number: +41 61 965 1389 |
Date of Submission: February 4, 2021
5.2 Name of the Device
| Trade Names: | Straumann TLX Novaloc and Cementable Abutments |
|---|---|
| Common Name: | Endosseous Dental Implant Abutment |
| Classification Name: | Endosseous Dental Implant Abutment |
| Regulation Number: | 21 CFR 872.3630 |
| Device Classification: | Class II |
| Product Code(s): | NHA |
| Classification Panel: | Dental devices |
| Proprietary Name: | Straumann TLX Novaloc and Cementable Abutments |
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Straumann TLX Novaloc and Cementable Abutments
510(k) Summary
5.3 Predicate Device(s)
Primary Predicate:
-
K193046 Straumann® Retentive System Novaloc TiN Abutments .
Reference Devices: -
K113283 Narrow Neck CrossFit (NNC) Cementable Abutments .
-
K200586 Straumann TLX Implant System .
-
. K190662 - MRI Compatibility for Existing Straumann Dental Implant Systems
5.4 Device Description
Straumann TLX Novaloc Abutments
The subject TLX Novaloc Abutments are intended to be placed onto Straumann TLX implants to provide support for full arch detachable restorations (over-denture). The coronal portion of the subject abutments is similar to the primary predicate devices, whereas the apical portion of the abutments has the appropriate implant-to-abutment interface geometry for each of the platforms of the Straumann TLX Implant System (NT, RT and WT). The Novaloc Abutments are manufactured from TAV (Ti-6Al-4V, Titanium-Aluminum-Vanadium). The restoration is connected to the Novaloc Abutment through a snap-on fixture provided by a negative shape of Novaloc snapon fixture embedded into the final restoration. The snap-on feature is TiN coated. The subject TLX Novaloc Abutments are provided in straight and angulated versions, in different heights. The TLX Novaloc Abutments are provided non-sterile with instructions for end user sterilization.
Straumann TLX Cementable Abutments
The subject TLX Cementable Abutments are intended to provide support for prosthetic reconstructions such as crowns and bridges and are used with cemented restorations. They are made of titanium alloy (Ti-6Al-7Nb or TAN) and are attached to the implant with a basal screw. To allow for more flexibility they are offered in a straight and in an angulated version for each of the three platforms (NT, RT and WT). The TLX Cementable Abutments are provided non-sterile with instructions for end user sterilization.
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Straumann TLX Novaloc and Cementable Abutments
510(k) Summary
5.5 Indications for Use
Straumann TLX Novaloc Abutments
The Straumann® Retentive System is indicated for the attachment of full or partial dentures on Straumann dental implants (NT, RT, and WT).
Straumann TLX Cementable Abutments
Prosthetic components directly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations. Final abutments may be placed into occlusion for implants with sufficient primary stability and with appropriate occlusal loading to restore chewing function or for implants that are fully osseointegrated.
5.6 Technological Characteristics
The technological characteristics of the subject devices are compared to the primary predicate and reference devices in Table 1 and Table 2.
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Straumann TLX Novaloc and Cementable Abutments
510(k) Summary
| FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE |
|---|---|---|---|
| K Number | K203355 | K193046Straumann® Retentive System -Novaloc TiN Abutments | K200586Straumann TLX Implant System(TLX Variobase for Crown) |
| Indications forUse | The Straumann® Retentive System isindicated for the attachment of full orpartial dentures on Straumann dentalimplants (NT, RT, and WT). | The Straumann® Retentive System isindicated for the attachment of full orpartial dentures on Straumann dentalimplants. | Straumann® Variobase® prosthetic components directlyconnected to the endosseous dental implant are intended foruse as an aid in prosthetic rehabilitations. The prostheticrestoration (crowns) can be cemented onto the Straumann®Variobase® prosthetic components. A temporary restorationcan be used prior to the insertion of the final components tomaintain, stabilize and shape the soft tissue during thehealing phase; they must be placed out of occlusion. Finalabutments and restorations may be placed into occlusionwhen the implant is fully osseointegrated. All digitallydesigned copings and/or crowns for use with the Straumann®Variobase® Abutment system are intended to be sent toStraumann for manufacture at a validated milling center. |
| Material | TAV (Ti-6Al-4V) | TAV (Ti-6Al-4V) | TAN (Ti-6Al-7Nb) |
| SurfaceTreatment | Coronal portion: TiN coatingApical portion: Laser marking | Coronal portion: TiN coatingApical portion: Laser marking | Laser marking |
| Implant toAbutmentConnection | TorcFit | CrossFit and synOcta | TorcFit |
| Prostheticplatform | NT, RT and WT | NC, RC, RN and WN | NT, RT and WT |
| GingivalHeight | Straight: 1, 2, 3, 4, 5, and 6 mmAngled: 2, 3, 4, 5, and 6 mm | Straight: 1, 2, 3, 4, 5, and 6 mmAngled: 2, 3, 4, 5, and 6 mm | 5.5 mm, 6 mm and 6,5 mm |
| Angulation | 0° and 15° | 0° and 15° | 0° |
| Sterilizationmethod | Moist heat end user sterilization | Moist heat end user sterilization | Moist heat end user sterilization |
| FEATURE | PROPOSED DEVICE | REFERENCE DEVICE | REFERENCE DEVICE |
| K Number | K203355 | K113283Narrow Neck CrossFit (NNC) CementableAbutments | K200586Straumann TLX Implant System |
| Indications forUse | Prosthetic components directly connectedto the endosseous dental implant areintended for use as an aid in prostheticrehabilitations. Final abutments may beplaced into occlusion for implants withsufficient primary stability and withappropriate occlusal loading to restorechewing function or for implants that arefully osseointegrated. | Abutments are used in connection with theprosthetic restoration of Straumann dentalimplants. Abutments are intended to beplaced into dental implants to provide supportfor prosthetic reconstructions such as crownsand bridges.Narrow Neck CrossFit CementableAbutments are indicated for cement-retainedsingle tooth and bridge restorations. | TLX Dental Implant:Straumann TLX Implants are suitable for endostealimplantation in the upper and lower jaws and for thefunctional and esthetic oral rehabilitation of edentulous andpartially edentulous patients. TLX Implants can be placedwith immediate function on single-tooth and multi-unitrestorations when good primary stability is achieved andwith appropriate occlusal loading to restore chewingfunction. The prosthetic restorations are connected to theimplants through the corresponding abutmentcomponents.TLX Variobase for Crown:Straumann Variobase prosthetic components directlyconnected to the endosseous dental implant are intendedfor use as an aid in prosthetic rehabilitations. Theprosthetic restoration (crowns) can be cemented onto theStraumann Variobase prosthetic components. A temporaryrestoration can be used prior to the insertion of the finalcomponents to maintain, stabilize and shape the soft tissueduring the healing phase; they must be placed out ofocclusion. Final abutments and restorations may be placedinto occlusion when the implant is fully osseointegrated. Alldigitally designed copings and/or crowns for use with theStraumann Variobase Abutment system are intended to besent to Straumann for manufacture at a validated millingcenter. |
| Material | TAN (Ti-6Al-7Nb) | Titanium, Grade 4 | TAN (Ti-6Al-7Nb) |
| SurfaceTreatment | Laser marking | Laser marking | Laser marking |
| Implant toAbutmentConnection | TorcFit | CrossFit | TorcFit |
| Prostheticplatform | NT, RT and WT | NNC | NT, RT and WT |
| FEATURE | PROPOSED DEVICE | REFERENCE DEVICE | REFERENCE DEVICE |
| K Number | K203355 | K113283Narrow Neck CrossFit (NNC) CementableAbutments | K200586Straumann TLX Implant System |
| Chimneyheight | Straight: 5,7 mm and 6 mmAngled: 6 mm | Straight: 5,7 mmAngled: 5,9 mm | 5.5 mm, 6 mm and 6,5 mm |
| Angulation | 0° and 15° | 0° and 15° | 0° |
| Sterilizationmethod | Moist heat end user sterilization | Moist heat end user sterilization | Moist heat end user sterilization |
Table 1 – Comparison of subject TLX Novaloc Abutments versus primary predicate and reference devices
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Straumann TLX Novaloc and Cementable Abutments
510(k) Summary
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Straumann TLX Novaloc and Cementable Abutments
510(k) Summary
Table 2 – Comparison of subject TLX Cementable Abutments versus reference devices
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Straumann TLX Novaloc and Cementable Abutments
510(k) Summary
5.7 Performance Testing
Bench Testing 5.7.1
Dynamic fatigue and static strength tests were conducted according to 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 ISO 14801, "Dentistry - Implants - Dynamic fatigue test for endosseous dental implants" and demonstrated that the Straumann TLX Novaloc and Cementable Abutments are equivalent to the primary predicate and reference devices.
5.7.2 Biocompatibility Testing
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 devices have equivalent nature of body contact duration, material formulation and sterilization methods compared to the primary predicate and reference devices, therefore, no new issues regarding biocompatibility were raised.
5.7.3 Sterilization Validation
The subject Straumann TLX Novaloc and Cementable Abutments are provided non-sterile and need to be sterilized by moist heat (steam) by the end-user. The recommended sterilization method 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, issued on March 17, 2015". There are no changes to the sterilization procedures or processes from those of the primary predicate and reference devices.
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Straumann TLX Novaloc and Cementable Abutments
510(k) Summary
5.8 Conclusion
The documentation submitted in this premarket notification demonstrates the Straumann TLX Novaloc and Cementable Abutments are substantially equivalent to the primary predicate and reference 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.)