Who is the manufacturer of Straumann® Retentive System – Novaloc TiN Abutments?

Institut Straumann AG filed the 510(k) submission for Straumann® Retentive System – Novaloc TiN Abutments (K193046).

What is the FDA product code for Straumann® Retentive System – Novaloc TiN 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® Retentive System – Novaloc TiN Abutments?

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

What are the predicate devices for Straumann® Retentive System – Novaloc TiN Abutments?

Straumann BLX Line Extension New Abutments (K190040).

Who can help prepare an FDA 510(k) submission like Straumann® Retentive System – Novaloc TiN 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® Retentive System – Novaloc TiN Abutments

K193046 · Institut Straumann AG · NHA · Aug 13, 2020 · Dental

Device Facts

Record ID	K193046
Device Name	Straumann® Retentive System – Novaloc TiN Abutments
Applicant	Institut Straumann AG
Product Code	NHA · Dental
Decision Date	Aug 13, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3630
Device Class	Class 2

Indications for Use

The Straumann® Retentive System is indicated for the attachment of full or partial dentures on Straumann dental implants and bar constructs.

Device Story

Straumann® Retentive System - Novaloc TiN Abutments are prosthetic components for dental implants; used to support full or partial arch detachable over-dentures. Abutments connect to Straumann dental implants via specific interface geometries (NC, RC, RN, WN); restoration connects to abutment via snap-on fixture. Abutments are manufactured from Ti-6Al-4V (TAV) alloy with TiN coating on snap-on feature. Available in straight and angulated models with varying heights. Used in dental clinics by clinicians; provided non-sterile for end-user moist heat sterilization. Output is a mechanical retention point for dentures; facilitates prosthetic rehabilitation for edentulous or partially edentulous patients.

Clinical Evidence

No clinical data submitted. Substantial equivalence supported by bench testing, including dynamic fatigue and static strength testing per ISO 14801 and FDA guidance for endosseous dental abutments, and sterilization validation per ISO 17665.

Technological Characteristics

Material: Ti-6Al-4V (TAV) alloy. Surface: TiN coating. Connection: Straumann NC, RC, RN, WN. Form factor: Straight and 15° angulated, heights 1-6 mm. Sterilization: Moist heat (steam) by end-user per ISO 17665-1/2. Mechanical retention via snap-on fixture.

Indications for Use

Indicated for patients requiring attachment of full or partial dentures to Straumann dental implants or bar constructs.

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 BLX Line Extension New Abutments (K190040)

Reference Devices

Locator Bar Female (K033699)
Straumann Variobase Abutments For Bridges/Bars (K151157)
Straumann CARES M-Series CAD/CAM System (K171649)
MRI Compatibility for Existing Straumann Dental Implant Systems (K190662)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. August 13, 2020 Institut Straumann AG % Jennifer Jackson Director, Regulatory Affairs Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01801 Re: K193046 Trade/Device Name: Straumann® Retentive System - Novaloc TiN Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: July 16, 2020 Received: July 17, 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. for Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ### Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K193046 Device Name: Straumann® Retentive System - Novaloc TiN Abutments Indications for Use (Describe) The Straumann® Retentive System is indicated for the attachment of full or partial dentures on Straumann dental implants and bar constructs. Type of Use (Select one or both, as applicable) 区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 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}------------------------------------------------ # K193046 – Traditional 510(k) # Straumann Retentive System – Novaloc TiN Abutments 510(k) Summary ### 510(k) Summary 5 ### 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 and Quality Phone Number: +1-978-747-2509 Fax Number: +1-978-747-0023 | | Prepared By & Alternate Contact: | Ana Carolina Martins Vianna Regulatory Affairs and Compliance Manager Institut Straumann AG Phone Number: +41 61 965 1259 | | Date of Submission: | August 11, 2020 | ### 5.2 Name of the Device | Trade Names: | Straumann® Retentive System – Novaloc TiN 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 | {4}------------------------------------------------ # K193046 - Traditional 510(k) ## Straumann Retentive System - Novaloc TiN Abutments 510(k) Summary ### 5.3 Predicate Device(s) Primary Predicate: - K190040 Straumann BLX Line Extension New Abutments . Reference Devices: - K033699 Locator Bar Female . - K151157 – Straumann Variobase Abutments For Bridges/Bars - . K171649 – Straumann CARES M-Series CAD/CAM System - K190662 MRI Compatibility for Existing Straumann Dental Implant Systems . ### Device Description 5.4 The subject Novaloc TiN Abutments are intended to be placed onto Straumann dental implants to provide support for full or partial arch detachable restorations (over-denture). The coronal portion of the subject abutments are 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 Dental Implant System. The Novaloc abutments are manufactured from TAV (Ti-6AI-4V, Titanium-Aluminum-Vanadium). The restoration is connected to the Novaloc abutment through a snap-on fixture provided by a negative shape of Novaloc snap-on fixture embedded into the final restoration. The snap-on feature is TiN coated. The subject Novaloc TiN Abutments are provided in straight and anqulated models, in different heights. The subject Novaloc TiN Abutment is also provided in a bar attachment. The Novaloc TiN abutments are provided non-sterile with instructions for end user sterilization. ### Intended Use 5.5 Prosthetic components connected to the implant or abutment, are intended for use as an aid in prosthetic rehabilitation. #### Indications for Use 5.6 The Straumann® Retentive System is indicated for the attachment of full or partial dentures on Straumann dental implants and bar constructs. {5}------------------------------------------------ # K193046 – Traditional 510(k) # Straumann Retentive System – Novaloc TiN Abutments 510(k) Summary #### Technological Characteristics 5.7 - The primary predicate devices and subject devices have many of the same technological characteristics. The abutment material, surface coating, angulation and snap-on feature are identical to the primary predicate device. The main technological difference is the implant-toabutment connections. Nevertheless, all subject connections are well established and compatible with FDA cleared Straumann implant connections (NC, RC, RN, and WN). A complete comparison of the primary and reference predicate devices with the subject abutments is provided in Table 1. | FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICES | | |------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | K Number | K193046 | K190040 | K171649 | K151157 | | Indications for Use | The Straumann Retentive System is indicated for the attachment of full or partial dentures on Straumann dental implants and bar constructs. | Straumann BLX Novaloc Abutments: The Straumann Retentive System is indicated for the attachment of full or partial dentures on Straumann dental implants. (Indications for Use related to other types of abutments are not considered in this table) | The Straumann CARES M-Series CAD/CAM System is indicated for the design and fabrication of single or multiple- unit implant-borne prosthetics for the restoration of partially or fully edentulous mandibles and maxillae. The system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners or Extra-Oral Scanners, CAD software, CAM software, restoration material blanks, milling machines and associated tooling and accessories. The system is used to design and fabricate CAD/CAM milled coping, crown and bridge restorations to be cemented onto Straumann® Variobase® Abutments, as well as milled abutments to be affixed to the endosseous dental implants of the Straumann® Dental Implant System using a basal screw. | Straumann Variobase prosthetic components directly connected to the endosseous dental implants are indicated for use as an aid in prosthetic rehabilitations. The prosthetic restoration (bridge or overdenture) can be cemented on the Straumann® Variobase prosthetic components. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and form the soft tissue during the healing phase. They may not be placed into occlusion. Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated. | | Material | TAV (Ti-6Al-4V) | TAV (Ti-6Al-4V) | Ti-6Al-7Nb | Ti-6Al-7Nb | | Surface Treatment | TiN coating | TiN coating | No coating | No coating | {6}------------------------------------------------ # K193046 – Traditional 510(k) ## Straumann Retentive System - Novaloc TiN Abutments | FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICES | | |--------------------------------------|----------------------------------------------------------------------------------------------------------------------|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------| | K Number | K193046 | K190040 | K171649 | K151157 | | Implant to Abutment Connection | Straumann NC connection Straumann RC connection Straumann RN connection Straumann WN connection | Straumann BLX connection | Straumann NC connection Straumann RC connection Straumann NNC connection Straumann RN connection Straumann WN connection | Straumann NC connection Straumann RC connection Straumann NNC connection Straumann RN connection Straumann WN connection | | Abutment Height | 1, 2, 3, 4, 5, and 6 mm | up to 6.5 mm | n/a | 3.5 - 5.2 mm | | Angulation | 0 and 15° | 0 and 15° | 30° of coping angulation | 30° of coping angulation | | Sterilization Method | Moist heat end user sterilization | Moist heat end user sterilization | Moist heat end user sterilization | Moist heat end user sterilization | 510(k) Summary Table 1 – Comparison of subject Novaloc TiN Abutments versus primary predicate and reference device The primary predicate (K190040) is included for reference to the Straumann BLX Novaloc Abutments. The indications for use for the primary predicate contains reference to many different types of abutments. The intended use and indications for use of the subject device are identical to the Straumann BLX Novaloc Abutments. The reference device K190662 is included for the MRI compatibility. The subject Novaloc Abutments for bar attachments are equivalent to the reference device K033699 as described in Table 2. | FEATURE | PROPOSED DEVICE | REFERENCE DEVICE | |---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | K Number | K193046 | K033699 | | Indications for Use | The Straumann® Retentive System is indicated for the attachment of full or partial dentures on Straumann dental implants and bar constructs. | The Locator Bar Attachment System is designed for use with overdentures or partial dentures retained in whole or in part by bar splinted endosseous implants in the mandible or maxilla | | Connection | Bar | Bar | | Abutment to restoration connection | Snap on feature | Snap on Feature | | Type of restoration | Multiunit | Multiunit | | Compatible Matrix System | Zest LOCATOR Valoc Novaloc | Zest LOCATOR | | Angulation | 0° | 0° | {7}------------------------------------------------ # K193046 - Traditional 510(k) ## Straumann Retentive System - Novaloc TiN Abutments | Material | Titanium grade 5 alloy (Ti-6Al-7V or TAV) | Titanium, Stainless Steel | |------------------|----------------------------------------------|---------------------------------------| | Abutment Coating | TiN | TiN | | Construction | One Piece | One Piece | | Sterility | Non-sterile End user sterilization | Non-sterile End user sterilization | 510(k) Summary Table 2 – Comparison of subject Novaloc Abutments for bar attachments versus reference device #### Performance Testing 5.8 The following performance data support the substantial equivalence determination. #### 5.8.1 Sterilization Validation The subject Novaloc TiN 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 applicable recommendations in the FDA quidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015". ### 5.8.2 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 the same nature of body contact, contact duration, material formulation and sterilization methods compared to the primary predicate devices. #### 5.8.3 Bench Testing Dynamic fatigue and static strength tests conducted according to the FDA guidance document "Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Rootform Endosseous Dental Implants and Endosseous Dental Abutments" and ISO 14801, Dentistry - Implants - Dynamic fatigue test for endosseous dental implants, demonstrated that the Straumann Novaloc TiN Abutments are equivalent to the predicate and reference devices. {8}------------------------------------------------ # K193046 -- Traditional 510(k) # Straumann Retentive System – Novaloc TiN Abutments 510(k) Summary ### 5.8.4 Clinical data No device specific clinical data has been submitted to demonstrate substantial equivalence. ### 5.9 Conclusion The documentation submitted in this premarket notification demonstrates the subject Straumann Novaloc TiN Abutments are substantially equivalent to the primary predicate and reference devices.

Straumann® Retentive System – Novaloc TiN Abutments

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Reference Devices

Submission Summary (Full Text)

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Straumann® Retentive System – Novaloc TiN Abutments

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Reference Devices

Submission Summary (Full Text)

Panel 1

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