(88 days)
No
The device description and performance studies focus on mechanical properties, biocompatibility, and sterilization, with no mention of AI or ML technologies.
No.
The device components are described as providing support for prosthetic restorations and aiding in prosthetic rehabilitations, which implies a restorative rather than therapeutic function.
No
The device description indicates these abutments are "intended for the attachment of full or partial dentures on Straumann dental implants" and to "provide support for prosthetic reconstructions such as crowns and bridges". This describes a therapeutic or restorative function, not a diagnostic one.
No
The device description clearly details physical components made of titanium alloy, intended for placement onto dental implants. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for the attachment of dentures and prosthetic rehabilitations directly to dental implants within the patient's mouth. This is a therapeutic and restorative function, not a diagnostic one performed in vitro (outside the body).
- Device Description: The description details the physical components (abutments made of titanium alloys) and their function in supporting dental prosthetics. There is no mention of analyzing samples from the human body to provide diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in these samples
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on in vitro analysis.
The device is a medical device used for dental restoration, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
NHA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Upper and lower jaws
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Testing: 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". The tests demonstrated that the Straumann TLX Novaloc and Cementable Abutments are equivalent to the primary predicate and reference devices.
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.
Sterilization Validation: The recommended sterilization method (moist heat/steam) 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.)
0
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.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (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
2
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)
3
Straumann TLX Novaloc and Cementable Abutments
510(k) Summary
5 510(k) Summary
5.1 Submitter's Contact Information
| Submitter: | Straumann USA, LLC
60 Minuteman Road
Andover, MA 01810
Registration No.: 1222315 Owner/Operator No.: 9005052 |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| | On the behalf of: |
| | Institut Straumann AG
Peter Merian-Weg 12
4052 Basel, Switzerland |
| Contact Person: | Jennifer M. Jackson, MS
Director of Regulatory Affairs
Phone Number: +1-978-747-2509
Fax Number: +1-978-747-0023 |
| Prepared By &
Alternate Contact: | Laure Kuhner
Regulatory Affairs Specialist
Institut Straumann AG
Phone 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 |
4
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.
5
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.
6
Straumann TLX Novaloc and Cementable Abutments
510(k) Summary
| FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE |
|---|---|---|---|
| K Number | K203355 | K193046 | |
| Straumann® Retentive System - | |||
| Novaloc TiN Abutments | K200586 | ||
| Straumann TLX Implant System | |||
| (TLX Variobase for Crown) | |||
| Indications for | |||
| Use | The Straumann® Retentive System is | ||
| indicated for the attachment of full or | |||
| partial dentures on Straumann dental | |||
| implants (NT, RT, and WT). | The Straumann® Retentive System is | ||
| indicated for the attachment of full or | |||
| partial dentures on Straumann dental | |||
| implants. | Straumann® Variobase® prosthetic components directly | ||
| connected to the endosseous dental implant are intended for | |||
| use as an aid in prosthetic rehabilitations. The prosthetic | |||
| restoration (crowns) can be cemented onto the Straumann® | |||
| Variobase® prosthetic components. A temporary restoration | |||
| can be used prior to the insertion of the final components to | |||
| maintain, stabilize and shape the soft tissue during the | |||
| healing phase; they must be placed out of occlusion. Final | |||
| abutments and restorations may be placed into occlusion | |||
| when the implant is fully osseointegrated. All digitally | |||
| designed copings and/or crowns for use with the Straumann® | |||
| Variobase® Abutment system are intended to be sent to | |||
| Straumann for manufacture at a validated milling center. | |||
| Material | TAV (Ti-6Al-4V) | TAV (Ti-6Al-4V) | TAN (Ti-6Al-7Nb) |
| Surface | |||
| Treatment | Coronal portion: TiN coating | ||
| Apical portion: Laser marking | Coronal portion: TiN coating | ||
| Apical portion: Laser marking | Laser marking | ||
| Implant to | |||
| Abutment | |||
| Connection | TorcFit | CrossFit and synOcta | TorcFit |
| Prosthetic | |||
| platform | NT, RT and WT | NC, RC, RN and WN | NT, RT and WT |
| Gingival | |||
| Height | Straight: 1, 2, 3, 4, 5, and 6 mm | ||
| Angled: 2, 3, 4, 5, and 6 mm | Straight: 1, 2, 3, 4, 5, and 6 mm | ||
| Angled: 2, 3, 4, 5, and 6 mm | 5.5 mm, 6 mm and 6,5 mm | ||
| Angulation | 0° and 15° | 0° and 15° | 0° |
| Sterilization | |||
| method | 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 | K113283 | |
| Narrow Neck CrossFit (NNC) Cementable | |||
| Abutments | K200586 | ||
| Straumann TLX Implant System | |||
| Indications for | |||
| Use | 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. | Abutments are used in connection with the | ||
| prosthetic restoration of Straumann dental | |||
| implants. Abutments are intended to be | |||
| placed into dental implants to provide support | |||
| for prosthetic reconstructions such as crowns | |||
| and bridges. |
Narrow Neck CrossFit Cementable
Abutments are indicated for cement-retained
single tooth and bridge restorations. | 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 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 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. |
| Material | TAN (Ti-6Al-7Nb) | Titanium, Grade 4 | TAN (Ti-6Al-7Nb) |
| Surface
Treatment | Laser marking | Laser marking | Laser marking |
| Implant to
Abutment
Connection | TorcFit | CrossFit | TorcFit |
| Prosthetic
platform | NT, RT and WT | NNC | NT, RT and WT |
| FEATURE | PROPOSED DEVICE | REFERENCE DEVICE | REFERENCE DEVICE |
| K Number | K203355 | K113283
Narrow Neck CrossFit (NNC) Cementable
Abutments | K200586
Straumann TLX Implant System |
| Chimney
height | Straight: 5,7 mm and 6 mm
Angled: 6 mm | Straight: 5,7 mm
Angled: 5,9 mm | 5.5 mm, 6 mm and 6,5 mm |
| Angulation | 0° and 15° | 0° and 15° | 0° |
| Sterilization
method | 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
7
Straumann TLX Novaloc and Cementable Abutments
510(k) Summary
8
Straumann TLX Novaloc and Cementable Abutments
510(k) Summary
Table 2 – Comparison of subject TLX Cementable Abutments versus reference devices
9
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.
10
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.