TSV BellaTek Encode Healing Abutments

K173374 · Biomet 3i · NHA · Dec 13, 2017 · Dental

Device Facts

• Record ID: K173374
• Device Name: TSV BellaTek Encode Healing Abutments
• Applicant: Biomet 3i
• Product Code: NHA · Dental
• Decision Date: Dec 13, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2

Intended Use

The TSV™ BellaTek® Encode® Healing Abutments are intended for use as an accessory to endosseous dental implants during endosseous and gingival healing to prepare gingival tissue for acceptance of a final abutment and restoration.

Device Story

TSV™ BellaTek® Encode® Healing Abutments are dental implant accessories used during the healing phase post-implant placement. They facilitate soft tissue contouring to create an emergence profile for final prostheses. The device features machined markings on the occlusal surface (Encode® Coding Scheme) that identify the mating implant's position and orientation. Clinicians use these markings during abutment-level impressions or intraoral scans to capture digital data for restorative planning. The device is used in a clinical setting by dental professionals. By providing a standardized coding system, the abutment simplifies the transition from the healing phase to the final restoration, potentially improving the accuracy of the final prosthesis fit and reducing chair time.

Clinical Evidence

No clinical data were included in this submission. Bench testing included radiation sterilization validation (ISO 11137-1/2), LAL testing (ANSI/AAMI ST 72), and biocompatibility, shelf-life, and MR evaluation by reference to predicate K170013.

Technological Characteristics

Material: Ti-6Al-4V ELI. Design: Internal connection healing abutment with machined occlusal markings for identification. Sterilization: Radiation (SAL 10^-6). MR conditional. Compatible with Tapered Screw-Vent and Trabecular Metal implant systems.

Indications for Use

Indicated for patients requiring endosseous dental implant healing; used as an accessory to prepare gingival tissue for final abutment and restoration.

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

• Eztetic™ BellaTek® Encode® Healing Abutments (K170013)

Reference Devices

• Zimmer Dental Implant System (K061410)
• Zimmer Dental Tapered Screw-Vent® T Implant, HA Coated (K133339)
• Zimmer Dental Tapered Screw-Vent® M Implant, HA Coated (K133339)
• Tapered Screw-Vent® X Implant (K113753)
• Zimmer Dental Trabecular Metal Implant System (K132258)

Submission Summary (Full Text)

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December 13, 2017

Biomet 3i % Linda Schulz Regulatory Affairs PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130

Re: K173374

Trade/Device Name: TSV™ BellaTek® Encode® Healing Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: October 26, 2017 Received: October 27, 2017

Dear Linda Schulz:

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. 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Mary S. Runner -S

For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known)

# K173374

Device Name

TSVTM BellaTek® Encode® Healing Abutments

#### Indications for Use (Describe)

The TSV™ BellaTek® Encode® Healing Abutments are intended for use as an accessory to endosseous dental implants during endosseous and gingival healing to prepare gingival tissue for acceptance of a final abutment and restoration.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# 510(k) Summary K173374 Biomet 3i TSV™ BellaTek® Encode® Healing Abutments

October 26, 2017

### ADMINISTRATIVE INFORMATION

| Manufacturer Name | Biomet 3i<br>4555 Riverside Drive<br>Palm Beach Gardens, FL 33410<br>Telephone: [phone]<br>Fax: [phone] |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact | Nichole O'Neil, Regulatory Affairs Specialist |
| Representative/Consultant | Linda K. Schulz, BSDH, RDH<br>Floyd G. Larson, MS, MBA<br>PaxMed International, LLC<br>12264 El Camino Real, Suite 400<br>San Diego, CA 92130<br>Telephone: [phone]<br>Fax: [phone]<br>Email: [e-mail]<br>[e-mail] |

# DEVICE NAME AND CLASSIFICATION

| Trade/Proprietary Name | TSVTM BellaTek® Encode® Healing Abutments |
|----------------------------|-------------------------------------------|
| Common Name | Dental Implant Abutment |
| Classification Name | Endosseous dental implant abutment |
| Classification Regulations | 21 CFR 872.3630, Class II |
| Product Code | NHA |
| Classification Panel: | Dental Products Panel |
| Reviewing Branch: | Dental Devices Branch |

# PREDICATE DEVICE INFORMATION

| Primary Predicate: | | |
|--------------------|--------------------------------------------------------|---------------------|
| K170013 | Eztetic™ BellaTek® Encode® Healing Abutments | Biomet 3i |
| | Reference Predicates for Compatibility: | |
| K061410 | Zimmer Dental Implant System | Zimmer Dental, Inc. |
| K133339 | Zimmer Dental Tapered Screw-Vent® T Implant, HA Coated | Zimmer Dental, Inc. |
| | Zimmer Dental Tapered Screw-Vent® M Implant, HA Coated | |
| K113753 | Tapered Screw-Vent® X Implant | Zimmer Dental, Inc. |
| K132258 | Zimmer Dental Trabecular Metal Implant System | Zimmer Dental, Inc. |

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510(k) Summary Page 2 of 4

### INDICATIONS FOR USE

The TSV™ BellaTek® Encode® Healing Abutments are intended for use as an accessory to endosseous dental implants during endosseous and gingival healing to prepare gingival tissue for acceptance of a final abutment and restoration.

# DEVICE DESCRIPTION

The purpose of this submission is to obtain 510(k) premarket clearance for the TSVIM BellaTek® Encode® Healing Abutments compatible with Tapered Screw-Vent® and Trabecular Metal implant systems. Abutments sizing is based on implant platform diameter.

TSV™ BellaTek® Encode® Healing Abutments are designed to aid in soft tissue contouring during the healing period after implant placement, creating an emergence profile for the final prosthesis. They have the added design feature of machined markings for identification when taking an abutment level impression or an intraoral scan/digital impression. The occlusal surface of the device include markings that provide information about the mating implant's position and orientation.

The principal of operation and Encode "Coding Scheme of the same as the primary predicate device. The pattern of the markings for the subject device is specific to the Tapered Screw-Vent", and Trabecular Metal implant lines.

| Compatible Implant Sizes | | | |
|--------------------------|---------------------------|---------------------------|-------------------------|
| Implant System | Implant Diameter<br>(mmD) | Implant Platform<br>(mmD) | Implant Length<br>(mmL) |
| Tapered Screw -Vent® | 3.7 | 3.5 | 8, 10, 11.5, 13,16 |
| Tapered Screw -Vent® | 4.1 | 3.5 | 8, 10, 11.5, 13,16 |
| Tapered Screw -Vent® | 4.7 | 4.5 | 8, 10, 11.5, 13,16 |
| Tapered Screw -Vent® | 6.0 | 5.7 | 8, 10, 11.5, 13,16 |
| Screw-Vent® | 3.3 | 3.5 | 8,10,13,16 |
| Screw-Vent® | 3.7 | 3.5 | 8,10,13,16 |
| Screw-Vent® | 4.7 | 4.5 | 8,10,13,16 |
| Trabecular Metal™ | 3.7 | 3.5 | 10, 11.5, 13 |
| Trabecular Metal™ | 4.1 | 3.5 | 10, 11.5, 13 |
| Trabecular Metal™ | 4.7 | 4.5 | 10, 11.5, 13 |
| Trabecular Metal™ | 6.0 | 5.7 | 10, 11.5, 13 |

Compatible Implant Sizes

# PERFORMANCE DATA

Non-clinical testing data submitted or relied upon to demonstrate substantial equivalence included radiation sterilization validation according to ISO 11137-1 and 11137-2, demonstrating assurance level (SAL) of 10 °, Limulus amebocyte lysate (LAL) testing according to AANSI/AAMI ST 72, biological evaluation according to ISO 10993-1 by reference to K170013, demonstrating acceptable biocompatibility, accelerated and real time aging studies by reference to K170013, demonstrating a shelf life of five years, and MR evaluation by reference to K170013. The subject devices are labeled as MR conditional.

No clinical data were included in this submission.

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# EQUIVALENCE TO MARKETED DEVICE

Biomet 3i submits the information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, the subject device, TSV™ BellaTek® Encode® Healing Abutments, is substantially equivalent in indications and design principles to the legally marketed primary predicate device.

| Comparison | Subject Device | Primary Predicate Device |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | TSVTM BellaTek® Encode® Healing<br>Abutments | K170013<br>The EzteticTM BellaTek® Encode®<br>Healing Abutments |
| | Biomet 3i | Biomet 3i |
| Indications for Use | The TSVTM BellaTek® Encode®<br>Healing Abutments are intended for use<br>as an accessory to endosseous dental<br>implants during endosseous and<br>gingival healing to prepare gingival<br>tissue for acceptance of a final<br>abutment and restoration. | The EzteticTM BellaTek® Encode®<br>Healing Abutments are intended for use<br>as an accessory to endosseous dental<br>implants during endosseous and gingival<br>healing to prepare gingival tissue for<br>acceptance of a final abutment and<br>restoration. |
| Design | | |
| Scanning Identification | Encode® Coding Scheme<br>(Machined Markings) | Encode® Coding Scheme<br>(Machined Markings) |
| Emergence Profile (mm) | 3.8, 5.0, 5.6, 6.0, 6.8 | 3.8, 5.0 |
| Platform Diameter (mm) | 3.5, 4.5, 5.7 | 2.9 |
| Gingival Height (mm) | 3, 5, 7 | 3, 4, 6, 8 |
| Implant/Abutment<br>Connection | Internal | Internal |
| Material | | |
| Abutment | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
| Screw | Ti-6Al-4V ELI | Ti-6Al-4V ELI |

The intended use of the subject device as a healing abutment machined markings for identification is the same as the primary predicate K170013. The Indications for the subject device is the same as the primary predicate Eztetic™ BellaTek® Encode® Healing Abutment, K170013, changing only the name.

The principal of operation and basic design of the Encode Coding Scheme of the subject device is the same as the primary predicate device, Eztetic™ BellaTek® Encode® Healing Abutment, K170013. The pattern of the markings for the subject device is specific to the Tapered Screw-Vent, and Trabecular Metal implant lines.

All of the subject device components are manufactured from the same facilities, using the same manufacturing processes as used for the previously cleared primary predicate device in K170013.

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# CONCLUSION

The subject device and the primary predicate device have intended use, have same technological characteristics, and are made of the same materials. The subject device and predicate devices encompass the same design principals, including the Encode® Coding Scheme. The subject and predicate devices are packaged in the same materials and are to be sterilized using the same methods.

The data included in this submission demonstrate substantial equivalence to the primary predicate device listed above.