Certain 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 Certain BellaTek Express or BellaTek Flex Abutments are intended to be sent to a Biomet 3i validated milling center for manufacture.

Device Description

The Certain 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. Certain BellaTek Express Abutment and BellaTek Flex Abutment are intended to be used with Biomet 3i Certain (Internal Hex) dental implants for single and multi-unit restorations. The subject device abutments are available in hexed (single-unit) and nonhexed (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.

AI/ML Overview

This document pertains to the 510(k) premarket notification for Certain BellaTek® Express and BellaTek® Flex Abutments, K183138. It describes dental implant abutments and does NOT describe an AI/ML medical device. Therefore, the information requested regarding acceptance criteria, study details, expert involvement, and ground truth for an AI/ML device cannot be extracted from this document.

The document discusses substantial equivalence to predicate devices based on:

Intended Use: Similar, supporting prosthetic devices in edentulous patients.
Operating Principle: Attaching to dental implants to restore chewing function.
Identical Materials: Titanium Alloy (Ti-6Al-4V ELI) and Zirconia for abutments.
Similar Fundamental Design: Including platform diameters, screw or cement retention options.

Performance Data (Non-clinical):

Sterilization Validation: Per FDA Guidance and ISO 17665-1 and ISO 17665-2, demonstrating a sterility assurance level (SAL) of 10^-6.
Biological Evaluation: In accordance with FDA Guidance and ISO 10993-1, demonstrating acceptable biocompatibility.
MR Testing Data: Leveraged, and the device is labeled as MR conditional.
Design & Development: In accordance with FDA Guidance Document for Root-form Endosseous Dental Implants and Abutments.

No clinical data was included in this submission.

Therefore, I cannot provide the information requested in the format of an AI/ML device acceptance criteria and study.

Summary

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July 2, 2019

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

Re: K183138

Trade/Device Name: Certain 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: June 5, 2019 Received: June 7, 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 (QS) 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. Acting Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known): K183138

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

Indications for Use:

Prescription Use	X_
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use	__________
(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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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
	Address:	4555 Riverside Drive
		Palm Beach Gardens, Florida 33410
	Phone:	(561) 776-6923
	Fax:	(561) 514-6316
		Contact Person: Krupal Patel
	Job Title:	Senior Regulatory Specialist
	Email:	krupal.patel@zimmerbiomet.com
II.	Proprietary Trade Name:	Certain 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:

GingiHue Abutments and Temporary Cylinders referenced in Biomet 3i Dental . Abutments and Restorative Components (K072642 / SE 12/20/2007)

Reference predicate device:

Titanium-base Abutments referenced in Terrats Medical SL's DESS Dental Smart . Solutions (K170588 / SE 08/08/2017)

VIII. Indications for Use:

Certain 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

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tooth prosthesis, in the mandible or maxilla. The prosthesis can be screw retained or cement retained.

IX. Device Description:

X. Summary of the Technological Characteristics:

The subject devices, Certain 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 3.4, 4.1, 5.0 and 6.0mm 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 similar to the Indications for Use statement for the Primary Predicate Device.

GingiHue Abutments and Temporary Cvlinders cleared in K072642 are used as a primary predicate device as the design features of these devices are similar to the subject device.

Subject Device	Primary Predicate Device	ReferencePredicate device
Certain BellaTek Expressand BellaTek FlexAbutments	K072642Biomet 3i Dental Abutments &Restorative Components	K170588DESS Dental SmartSolutions
Biomet 3i	Biomet 3i	Terrats Medical SL
Indications forUse	Certain BellaTek Expressand BellaTek Flex	Biomet 3i Dental Abutmentsare intended for use as

Table 1: General device comparison

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Comparison	Subject Device	Primary Predicate Device	ReferencePredicate device
	Certain BellaTek Expressand BellaTek FlexAbutmentsBiomet 3i	K072642Biomet 3i Dental Abutments &Restorative ComponentsBiomet 3i	K170588DESS Dental SmartSolutionsTerrats Medical SL
	Abutments are intended	accessories to endosseous	are intended to be
	for use as accessories toendosseous dentalimplant to support aprosthetic device in apartially or completelyedentulous patient. Adental abutment isintended for use tosupport single andmultiple tooth prosthesis,in the mandible ormaxilla. The prosthesiscan be screw retained orcement retained.All digitally designedsuperstructure and/orhybrid abutment crownsfor use with CertainBellaTek Express andBellaTek Flex Abutmentsare intended to be sent toa Biomet 3i validatedmilling center formanufacture.	dental implant to support aprosthetic device in a partiallyor completely edentulouspatient. A dental abutment isintended for use to supportsingle and multiple toothprosthesis, in the mandible ormaxilla. The prosthesis can bescrew retained or cementretained.Restorative Components:• Temporary healingabutments are intended foruse to shape and maintainthe soft tissue openingduring healing• Castable restorativecomponents are intended foruse as accessories toendosseous dental implantsto aid in the fabrication ofdental prosthesis• Screw components areintended for use asaccessories to endosseousdental implants for retentionof screw retained abutmentsto the dental implant	used in conjunctionwith endosseousdental implantsin the maxillary ormandibular arch toprovide support forprostheticrestorations.All digitally designedcustom abutments foruse with TiBase orPre-milled Blank areto be sent to a TerratsMedical validatedmilling center formanufacture.
Intended Use	It is a device, whichattaches to the dentalimplant to restorechewing function.	It is a device, which attaches tothe dental implant to restorechewing function.	It is a device, whichattaches to the dentalimplant to restorechewing function.
Design
PlatformDiameter	3.4, 4.1, 5.0 and 6.0mm	3.4, 4.1, 5.0 and 6.0mm	3.4 - 5.7mm
Abutment Angle	Straight	Straight to 30°	Straight
ProsthesisAttachment	Screw or Cement retained	Screw or Cement retained	Screw or Cementretained
Restoration	Single unit &Multi unit	Single unit &Multi unit	Single unit &Multi unit
Implant/AbutmentConnection	Biomet 3i InternalHex Implants	Biomet 3i Internal andExternal Hex Implants	Biomet 3i, NobelBiocare, Astra Tech,Zimmer Dental

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Comparison	Subject Device	Primary Predicate Device	ReferencePredicate device
	Certain BellaTek Expressand BellaTek FlexAbutments	K072642Biomet 3i Dental Abutments &Restorative Components	K170588DESS Dental SmartSolutions
	Biomet 3i	Biomet 3i	Terrats Medical SL
			Straumann &Dentsply Implants
Material
Abutment	Titanium Alloy(Ti-6Al-4V ELI) andZirconia	Titanium Alloy(Ti-6Al-4V ELI) &Commercial Pure Titanium	Titanium Alloy(Ti-6Al-4V ELI)

Certain BellaTek Express and BellaTek Flex abutments are substantially equivalent in design, function, material, and Indications for Use to GingiHue Abutments & Titanium Temporary Cylinders referenced in Biomet 31's Dental Abutments (K072642) and Titanium-base abutments referenced in Terrats Medical SL's Dess Dental Smart Solutions (K170588). All 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 reference device are to be sent to a validated milling center for manufacture.

XI. Performance Data:

Non-clinical testing was conducted per FDA Guidance Document (Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling) and steam sterilization validation according to ISO 17665-1 and ISO 17665-2. demonstrating a sterility assurance level (SAL) of 10to of the device. Biological evaluation was conducted in accordance with 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") demonstrating acceptable biocompatibility of the device. MR testing data is leveraged and the subject device is labeled as MR conditional. Devices were designed & developed in accordance to applicable FDA Guidance Document (Guidance for Industry and FDA staff – Class II special controls guidance document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments).

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.

Regulation Number and Section

§ 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.)