Who is the manufacturer of Straumann TLX Novaloc and Cementable Abutments?

Institut Straumann AG filed the 510(k) submission for Straumann TLX Novaloc and Cementable Abutments (K203355).

What is the FDA product code for Straumann TLX Novaloc and Cementable Abutments?

NHA. It is classified under 21 CFR 872.3630 as a Class 2 device in the Dental panel.

What is the regulatory pathway for Straumann TLX Novaloc and Cementable Abutments?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Straumann TLX Novaloc and Cementable Abutments?

Straumann® Retentive System Novaloc TiN Abutments (K193046).

Who can help prepare an FDA 510(k) submission like Straumann TLX Novaloc and Cementable Abutments?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Straumann TLX Novaloc and Cementable Abutments

K203355 · Institut Straumann AG · NHA · Feb 12, 2021 · Dental

Device Facts

Record ID	K203355
Device Name	Straumann TLX Novaloc and Cementable Abutments
Applicant	Institut Straumann AG
Product Code	NHA · Dental
Decision Date	Feb 12, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3630
Device Class	Class 2
Attributes	Therapeutic

Intended 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.

Device Story

Straumann TLX Novaloc and Cementable Abutments are prosthetic components for dental implants. Novaloc abutments support full-arch detachable over-dentures via snap-on fixtures; cementable abutments support crowns and bridges. Both types connect to Straumann TLX implants (NT, RT, WT platforms) using a TorcFit interface. Manufactured from titanium alloys (Ti-6Al-4V or Ti-6Al-7Nb), they are provided non-sterile for end-user moist heat sterilization. Clinicians select appropriate heights and angulations (0° or 15°) to restore chewing function. The device facilitates prosthetic rehabilitation by providing a stable interface between the endosseous implant and the final dental restoration.

Clinical Evidence

Bench testing only. Dynamic fatigue and static strength testing conducted per ISO 14801 and FDA guidance for endosseous dental abutments. Biocompatibility evaluated per ISO 10993-1. Sterilization validated per ISO 17665-1/2.

Technological Characteristics

Materials: TAV (Ti-6Al-4V) or TAN (Ti-6Al-7Nb). Interface: TorcFit. Surface: TiN coating (Novaloc coronal) and laser marking. Sterilization: Moist heat (steam) end-user. Form factor: Straight and angulated (15°) abutments for NT, RT, WT platforms.

Indications for Use

Indicated for patients requiring full or partial denture attachment or prosthetic rehabilitation (crowns/bridges) on Straumann dental implants (NT, RT, WT).

Regulatory Classification

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.

Special Controls

*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.)

Predicate Devices

Straumann® Retentive System Novaloc TiN Abutments (K193046)

Reference Devices

Narrow Neck CrossFit (NNC) Cementable Abutments (K113283)
Straumann TLX Implant System (K200586)
MRI Compatibility for Existing Straumann Dental Implant Systems (K190662)

Related Devices

K193046 — Straumann® Retentive System Novaloc TiN Abutments · Institut Straumann AG · Aug 13, 2020
K231874 — AOT & T-L Abutment · Truabutment, Inc. · Oct 30, 2023
K071838 — NEOSS VARIOUS TITANIUM ABUTMENTS · Neoss, Ltd. · Oct 19, 2007
K233167 — LW Implant System Abutment · Ossvis Co., Ltd. · Mar 25, 2024
K151375 — Inclusive Titanium Abutments compatible with: Hiossen HG Implant System · Prismatik Dentalcraft, Inc. · Oct 7, 2015

Submission Summary (Full Text)

{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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED #### This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff @fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." 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.