TSV BellaTek Express and BellaTek Flex Abutments

K192522 · Biomet 3i, LLC · NHA · Dec 9, 2019 · Dental

Device Facts

• Record ID: K192522
• Device Name: TSV BellaTek Express and BellaTek Flex Abutments
• Applicant: Biomet 3i, LLC
• Product Code: NHA · Dental
• Decision Date: Dec 9, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

TSV BellaTek® Express and BellaTek® Flex Abutments are intended for use as accessories to endosseous dental implants to support a prosthetic device in a partially or completely edentulous patient. A dental abutment is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be screw retained or cement retained. All digitally designed superstructures and/or hybrid abutment crowns for use with TSV BellaTek Express or BellaTek Flex Abutments are intended to be sent to a Biomet 3i validated milling center for manufacture.

Device Story

TSV BellaTek Express and Flex Abutments are two-piece titanium alloy abutments used as accessories for endosseous dental implants. The apical component is a titanium-base abutment; the coronal component is a CAD/CAM-manufactured superstructure (zirconia). The device is used in dental clinics by clinicians to restore chewing function in partially or completely edentulous patients. The abutment is placed on the implant and secured with a titanium alloy retaining screw. Digitally designed superstructures are sent to a Biomet 3i validated milling center for fabrication. The system supports both screw-retained and cement-retained prostheses. The device is sold non-sterile (abutment) or sterile (screw). It is compatible with Zimmer Dental Tapered Screw-Vent, Screw-Vent, and Trabecular Metal implant systems.

Clinical Evidence

No clinical data was included in this submission. Substantial equivalence is supported by non-clinical bench testing, including sterilization validation (ISO 17665-1, ISO 11137-1/2), biocompatibility (ISO 10993-1), and MR conditional status.

Technological Characteristics

Titanium alloy (Ti-6Al-4V ELI) abutments and screws; zirconia superstructures (ISO 13356:2015, ISO 6872:2015). Available in 3.5mm, 4.5mm, 5.7mm platform diameters. Mechanical connection to dental implants via retaining screw. Non-sterile (abutment) and sterile (screw) packaging. MR conditional.

Indications for Use

Indicated for partially or completely edentulous patients requiring single or multiple tooth prostheses in the mandible or maxilla, supported by endosseous dental implants.

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

• Certain BellaTek Express and BellaTek Flex Abutment (K183138)

Reference Devices

• Zimmer Zfx Titanium Base Abutment (K133551)
• Ivoclar Vivadent Multilink Hybrid Abutment Cement (K130436)
• K150571

Submission Summary (Full Text)

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December 9, 2019

Biomet 3i LLC Krupal Patel Senior Regulatory Specialist 4555 Riverside Drive Palm Beach Gardens, Florida 33410

Re: K192522

Trade/Device Name: TSV BellaTek® Express and BellaTek® Flex Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: September 11, 2019 Received: September 13, 2019

Dear Krupal Patel:

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 ([e-mail]) or phone [phone] 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

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# INDICATIONS FOR USE

## 510(k) Number (if known): K192522

Device Name: TSV BellaTek® Express and BellaTek® Flex Abutments

## Indications for Use:

TSV BellaTek® Express and BellaTek® Flex Abutments are intended for use as accessories to endosseous dental implants to support a prosthetic device in a partially or completely edentulous patient. A dental abutment is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be screw retained or cement retained.

All digitally designed superstructures and/or hybrid abutment crowns for use with TSV BellaTek Express or BellaTek Flex Abutments are intended to be sent to a Biomet 3i validated milling center for manufacture.

Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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# TSV BellaTek® Express and BellaTek® Flex Abutments 510(k) Summary K192522 9/December/2019

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.92

### I. Submitter Information:

| Name: | Biomet 3i LLC | | | |
|-----------------|-----------------------------------|-----------------------|------------------------------------------------------|--|
| Address: | 4555 Riverside Drive | | | |
| | Palm Beach Gardens, Florida 33410 | | | |
| Phone: | [phone] | | | |
| Fax: | [phone] | | | |
| Contact Person: | Krupal Patel | | | |
| Job Title: | Senior Regulatory Specialist | | | |
| Email: | [e-mail] | | | |
| II. | Proprietary Trade Name: | | TSV BellaTek® Express and BellaTek® Flex Abutments | |
| III. | Device Classification Name: | | Endosseous Dental Implant Abutment (21 CFR 872.3630) | |
| IV. | Regulatory Class: | | Class II | |
| V. | Product Code: | NHA | | |
| VI. | Reviewing Branch: | Dental Devices Branch | | |

### VII. Predicate Devices:

## Primary predicate device:

- Certain BellaTek Express and BellaTek Flex Abutment (K183138 / SE 07/02/2019) .
### Reference Predicate Device:

- Zimmer Zfx Titanium Base Abutment (K133551 / SE 07/18/2014) .
### VIII. Indications for Use:

TSV BellaTek Express and BellaTek Flex Abutments are intended for use as accessories to endosseous dental implants to support a prosthetic device in a partially or completely edentulous patient. A dental abutment is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be screw retained or cement retained.

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All digitally designed superstructures and/or hybrid abutment crowns for use with TSV BellaTek Express or BellaTek Flex Abutments are intended to be sent to a Biomet 3i validated milling center for manufacture.

### IX. Device Description:

The TSV BellaTek Express Abutment and BellaTek Flex Abutment (subject devices) are Titanium-base type abutments to be used as the apical part of two-piece abutments. The coronal part of the two-piece abutment is a CAD/CAM designed and manufactured superstructure. All digitally designed superstructures manufactured in zirconia conform to ISO 13356:2015 and ISO 6872:2015. Biomet 3i recommends the use of Ivoclar Vivadent Multilink Hybrid Abutment Cement (K130436) to affix the zirconia superstructure and/or hybrid abutment crown to the Certain BellaTek Express and BellaTek Flex abutments. TSV BellaTek Express Abutment and BellaTek Flex Abutment are intended to be used with Zimmer Dental's Tapered Screw-Vent, Screw-Vent and Trabecular Metal dental implants for single and multi-unit restorations. The subject device abutments are available in hexed (single-unit) and non-hexed (multi-unit) configurations. They are available in pre-defined platform diameters, emergence profiles and heights to accommodate varying patient anatomies. They are machined from Titanium Alloy. They are intended for single use only. The device is packaged in a sealed nylon bag and sold non-sterile.

The TSV Titanium ASC screw used with the subject device is also machined from Titanium Alloy and anodized pink. The device is packaged individually in a sealed nylon bag and sold sterile. When the TSV BellaTek Express or BellaTek Flex Abutment is placed on the corresponding implant, the retaining screw will mate with the internal thread feature of the dental implant to hold the abutment in place.

Biomet 3i LLC and Zimmer Dental, Inc. have merged under Zimmer Biomet. This 510(k) Premarket Notification is submitted under the entity Biomet 3i LLC. Design and manufacturing parameters including dimensions, tolerances, material specifications, and manufacturing processes have been shared within Zimmer Dental and Biomet 3 i LLC to ensure the subject TSV BellaTek Express and BellaTek Flex Abutments are compatible with Zimmer Dental's Tapered Screw-Vent, Screw-Vent and Trabecular Metal implant systems.

### X. Summary of the Technological Characteristics:

The subject devices, TSV BellaTek Express Abutment and BellaTek Flex Abutment, are Titanium-base type abutments to be used as the apical part of two-piece abutments. They feature a narrow collar for improved aesthetics, pre-grooved preparation markings for varying occlusal heights, and the screw or cement retained restoration option. Subject device abutments are available in 3.5mm, 4.5mm and 5.7mm platform diameters. A general device comparison of the subject and predicate devices is provided in Table 1.

The Indications for Use statement for the subject device is the same as that for the primary predicate device, except for the name of the device.

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Certain BellaTek Express and BellaTek Flex Abutments cleared in K183138 are used as a primary predicate device as the design features of these devices are similar to the subject device.

| Comparison | Subject Device | Primary Predicate<br>Device (K183138) | Reference Predicate<br>Device (K133551) |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | TSV BellaTek Express<br>and BellaTek Flex<br>Abutment | Certain BellaTek Express<br>and BellaTek Flex<br>Abutment | Zimmer Zfx Titanium Base<br>Abutments for Tapered<br>Screw-Vent Implant System |
| | Biomet 3i | Biomet 3i | Zimmer Dental |
| Indications<br>for Use | The TSV BellaTek<br>Express and BellaTek<br>Flex Abutments are<br>intended for use as<br>accessories to<br>endosseous dental<br>implants to support a<br>prosthetic device in a<br>partially or completely<br>edentulous patient. A<br>dental abutment is<br>intended for use to<br>support single and<br>multiple tooth<br>prostheses, in the<br>mandible or maxilla.<br>The prostheses can be<br>screw retained or<br>cement retained.<br>All digitally designed<br>superstructures and/or<br>hybrid abutment<br>crowns for use with<br>TSV BellaTek Express<br>or BellaTek Flex<br>Abutments are intended<br>to be sent to a Biomet<br>3i validated milling<br>center for manufacture. | The Certain BellaTek<br>Express and BellaTek Flex<br>Abutments are intended for<br>use as accessories to<br>endosseous dental implants<br>to support a prosthetic<br>device in a partially or<br>completely edentulous<br>patient. A dental abutment<br>is intended for use to<br>support single and multiple<br>tooth prostheses, in the<br>mandible or maxilla. The<br>prostheses can be screw<br>retained or cement retained.<br>All digitally designed<br>superstructures and/or<br>hybrid abutment crowns for<br>use with Certain BellaTek<br>Express or BellaTek Flex<br>Abutments are intended to<br>be sent to a Biomet 3i<br>validated milling center for<br>manufacture. | The Zimmer Zfx Titanium<br>Base Abutment is a<br>combination of a pre-<br>manufactured (stock)<br>abutment and the Zimmer<br>Zfx Abutment Coping or<br>Crown as part of a straight<br>or angled two- piece<br>abutment. The combination<br>of the titanium base stock<br>abutment and the abutment<br>coping is designed for use<br>as a terminal or<br>intermediate abutment for<br>cement or screw retained<br>prostheses. The two-piece<br>abutment is used for a<br>single-unit or multi-unit<br>(bridge) restoration. The<br>Zimmer Zfx Abutment<br>Coping shall be<br>manufactured by an<br>approved Zimmer Dental<br>milling facility. |
| Intended<br>Use | It is a device, which<br>attaches to the dental<br>implant to restore<br>chewing function. | It is a device, which<br>attaches to the dental<br>implant to restore chewing<br>function. | It is a device, which attaches<br>to the dental implant to<br>restore chewing function. |
| Platform<br>Diameter | 3.5mm, 4.5mm<br>and 5.7mm | 3.4mm, 4.1mm, 5.0mm<br>and 6.0mm | 3.5mm, 4.5mm<br>and 5.7mm |
| Abutment | 4.75 and 12mm | 4.75 and 12mm | 3.9mm |
| Comparison | Subject Device | Primary Predicate<br>Device (K183138) | Reference Predicate<br>Device (K133551) |
| | TSV BellaTek Express<br>and BellaTek Flex<br>Abutment<br>Biomet 3i | Certain BellaTek Express<br>and BellaTek Flex<br>Abutment<br>Biomet 3i | Zimmer Zfx Titanium Base<br>Abutments for Tapered<br>Screw-Vent Implant System<br>Zimmer Dental |
| Height | | | |
| Abutment<br>Angle | Straight | Straight | Straight |
| Implant<br>/Abutment<br>Connection | Zimmer Dental's<br>Tapered Screw-Vent,<br>Screw-Vent and<br>Trabecular Metal<br>Implants | Biomet 3i Internal Hex<br>Implants | Zimmer Dental's Tapered<br>Screw-Vent and Screw-Vent<br>Implant System |
| Restoration | Single unit &<br>Multi unit | Single unit &<br>Multi unit | Single unit &<br>Multi unit |
| Prosthesis<br>Attachment | Screw or Cement<br>retained | Screw or Cement retained | Screw or Cement retained |
| Abutment | Titanium Alloy<br>(Ti-6Al-4V ELI) and<br>Zirconia | Titanium Alloy<br>(Ti-6Al-4V ELI) and<br>Zirconia | Titanium Alloy<br>(Ti-6Al-4V ELI) |
| Retaining<br>Screw | Titanium Alloy<br>(Ti-6Al-4V ELI) | Stainless Steel 316L, Gold<br>Alloy or Palladium Alloy | Titanium Alloy<br>(Ti-6Al-4V ELI) |

# Table 1: General device comparison

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TSV BellaTek Express and BellaTek Flex Abutments are substantially equivalent in design, function, material, and Indications for Use to Certain BellaTek Express and BellaTek Flex Abutments (K183138). They are intended for use with endosseous dental implants in the maxilla and mandible to provide prosthetic support. All digitally designed superstructures for use with the subject device and the primary predicate device are to be sent to a validated milling center for manufacture. The subject device and the reference predicate device (K133551) has same platform diameters. They are available in 3.5mm, 4.5mm and 5.7mm platform diameters compatible with the corresponding Zimmer Dental implants.

### XI. Performance Data:

Non-clinical testing data submitted or relied upon to demonstrate substantial equivalence included steam sterilization validation according to ISO 17665-1 and gamma sterilization validation according to ISO 1137-1 and ISO 11137-2, demonstrating a sterility assurance level (SAL) of 106, biological evaluation according to ISO 10993-1 demonstrating acceptable biocompatibility by reference to K183138, and Magnetic Resonance testing showing the device as MR conditional by reference to K150571.

Aging/Shelf-Life is not applicable to the subject device abutment, TSV BellaTek Express and BellaTek Flex Abutment, as it is supplied non-sterile.

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The retaining screw, TSV Titanium Angled Screw Channel Screw, used with the subject device abutment is packaged in the same packaging system (Nylon Bag) as the retaining screw, Certain Gold-Tite Hexed UniScrew that is used with the predicate device abutment and will maintain an identical 5-year shelf-life. Sterilization is accomplished using gamma radiation at an exposure dose of 25 to 38 kGv and was validated under a dose setter using VDmax35 method in accordance with "ISO 11137-2, Sterilization of Health Care Products -Radiation Part 2 – Establishing the sterilization dose". This validated dose results in a minimum sterility assurance of 106. Sterilization and dose audits are conducted in accordance with "ISO 11137-1, Sterilization of Health Care Products – Radiation Part 1 Requirements for Development, Validation and Routine Control of a sterilization process for medical devices". Biomet 3i conducts quarterly dose audits for devices that are sterilized using gamma radiation method. Shelf life of the nylon bags used to package the device has been verified by conducting accelerated aging and real-time aging studies of nylon bags in accordance with Biomet 3i quality procedures. Subsequent to the aging studies, shipping and distribution study was also performed per "ASTM D4169 - Standard practice for performance testing of shipping containers and systems" to determine the ability of the product structure to withstand shipping/vibration conditions in the packaging. Upon completion of the shipping and distribution test, the sterile barrier integrity was tested by dye penetration and seal strength methods and it met the acceptance criteria of these tests per "ISO 11607-1 : Packaging for terminally sterilized medical devices – Part 1 : Requirements for materials, sterile barrier systems and packaging systems". These tests demonstrated that the product packaging was able to maintain a sterile barrier over the length of its labeled shelf life.

Devices were designed & developed in accordance to following applicable FDA Guidance Document:

- 1) Guidance for Industry and FDA staff Class II special controls guidance document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments
- 2) Guidance for Industry and FDA staff Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling
- 3) Guidance for Industry and FDA staff Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile
- 4) Guidance for Industry and FDA staff Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process".

No clinical data was included in this submission.

#### XII. Conclusion:

The subject device has demonstrated substantial equivalence to the predicate devices in that it has the same intended use, the same operating principle, identical materials and similar fundamental design.