The Eztetic™ 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 Eztetic™ BellaTek® Encode® Healing Abutment is a healing abutment designed to facilitate gingival tissue healing. It consists of an abutment and a retaining screw that are assembled together. Both components are machined from Titanium Alloy (Ti-6AL-4V ELI). The shelf life of the Eztetic™ BellaTek® Encode® Healing Abutment is 5 years and they are intended for single use only. The device is packaged in a sealed nylon bag and sold sterile. The device is sterilized using gamma irradiation method.

AI/ML Overview

This document, a 510(k) summary for the Eztetic™ BellaTek® Encode® Healing Abutments, describes non-clinical testing performed to establish substantial equivalence to predicate devices, rather than a clinical study evaluating the device's performance against specific acceptance criteria.

Therefore, I cannot provide the information requested regarding acceptance criteria and a study proving the device meets those criteria, as these are typically associated with clinical performance studies, which are not detailed in this document.

However, I can extract information about the non-clinical testing performed to demonstrate substantial equivalence:

Non-Clinical Testing Information:

Since this is a non-clinical evaluation for substantial equivalence, the concepts of "acceptance criteria," "reported device performance," "sample size for test set," "data provenance," "number of experts," "adjudication method," "MRMC study," "standalone study," "type of ground truth," "sample size for training set," and "how ground truth for training set was established" are not directly applicable in the way they would be for a clinical efficacy or safety study.

Instead, the document describes tests conducted to ensure the new device is comparable to existing, legally marketed devices.

Here's a breakdown of the non-clinical testing mentioned:

1. Acceptance Criteria and Reported Device Performance (Non-Clinical Equivalence):

Non-Clinical Test / Characteristic	Acceptance Criteria (Implied by Equivalence)	Reported Performance (Implied by Conclusion of Substantial Equivalence)
MR Compatibility	Device is MR conditional (same as previously tested Biomet 3i devices).	The subject devices, having less surface area and volume and made of identical materials as previously tested MR-compatible Biomet 3i devices, are considered MR conditional.
Biocompatibility	Biologically compatible (same as primary predicate devices).	The subject devices, made of identical materials and manufactured under identical conditions as primary predicate devices, leverage the predicate's biocompatibility data.
Sterilization Efficacy	Minimum Sterility Assurance Level (SAL) of 10⁻⁶; compliance with ISO 11137-1 and ISO 11137-2.	Sterilization validated at 25-38 kGy using gamma irradiation, achieving a SAL of 10⁻⁶, consistent with ISO standards. Quarterly dose audits are conducted.
Shelf-Life	Maintain structural integrity and performance for 5 years.	Substantiated 5-year shelf-life based on material stability (Ti-6Al-4V ELI) and successful accelerated/real-time aging studies of packaging.
Packaging Integrity	Maintain sterile barrier over labeled shelf life; withstand shipping/vibration conditions without compromise to sterility.	Met acceptance criteria for dye penetration and seal strength after accelerated/real-time aging and shipping/distribution testing (per ISO 11607-1, ASTM D4169).
Torque to Failure	Withstand recommended torque (similar to primary predicate devices).	Performance demonstrated to be substantially equivalent to predicate devices. (Specific values not provided, but passed).
Physical Fit Check	Device fits correctly with the mating implant (similar to primary predicate devices).	Performance demonstrated to be substantially equivalent to predicate devices. (Specific details not provided, but passed).
Tolerance Analysis	Entire tolerance range meets design input (similar to primary predicate devices).	Performance demonstrated to be substantially equivalent to predicate devices. (Specific details not provided, but passed).
Print Verification	Properly constrained and accurately describes intended original design (similar to primary predicate devices).	Performance demonstrated to be substantially equivalent to predicate devices. (Specific details not provided, but passed).

2. Sample Size for Test Set and Data Provenance:

Sample Size: Not explicitly stated for any of the non-clinical tests.
Data Provenance: The data is primarily derived from "leveraged" data from previously tested Biomet 3i devices and predicate devices, as well as new bench testing. There is no mention of country of origin as it's non-clinical lab testing. All testing appears to be prospective in the sense that the tests were conducted for this submission, although some rely on retrospective leveraging of prior data.

3. Number of Experts and Qualifications (for Ground Truth):

This concept is not directly applicable to the non-clinical tests described. The "ground truth" here is adherence to engineering specifications, material properties, and regulatory standards, evaluated by qualified personnel within the company and verified by regulatory bodies.

4. Adjudication Method for Test Set:

Not applicable as these are non-clinical engineering and material tests, not expert-adjudicated clinical data.

5. MRMC Comparative Effectiveness Study:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is for evaluating human performance, often with AI assistance, in interpreting medical images or data. The device in question is a physical dental healing abutment, not an AI diagnostic tool.

6. Standalone Study (Algorithm Only Without Human-in-the-Loop Performance):

No, a standalone study in this context (algorithm performance) was not done as the device is a physical medical device, not an algorithm or software. The "standalone" performance here refers to the physical and material characteristics themselves, which are addressed by the non-clinical bench testing.

7. Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" is based on:
- Regulatory Standards: ISO 11137-1, ISO 11137-2, ISO 11607-1, ASTM D4169, ASTM F 136.
- Engineering Specifications: Design inputs, tolerance ranges, recommended torque values.
- Material Science Properties: Known characteristics of Ti-6Al-4V ELI.
- Prior Validated Test Data: From predicate and previously tested Biomet 3i devices (e.g., for MR compatibility, biocompatibility).

8. Sample Size for the Training Set:

Not applicable. This is not an AI/machine learning device that would have a "training set."

9. How the Ground Truth for the Training Set Was Established:

Not applicable.

Summary

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Image /page/0/Picture/1 description: The image contains the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 21, 2017

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

Re: K170013

Trade/Device Name: Eztetic™ BellaTek® Encode® Healing Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: September 1, 2017 Received: September 5, 2017

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. 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.

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

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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INDICATIONS FOR USE

510(k) Number (if known): K170013

Device Name: Eztetic™ BellaTek® Encode® Healing Abutments

Indications for Use:

Prescription Use	X
(Part 21 CFR 801 Subpart D)
Over-The-Counter Use
(21 CFR 801 Subpart C)

AND/OR

(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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Eztetic™ BellaTek® Encode® Healing Abutments 510(K) Summary 09/21/2017

I. Submitter Information:

	Name:	Biomet 3i
	Address:	4555 Riverside Drive
		Palm Beach Gardens, Florida 33410
	Phone:	(561) 776-6700
	Contact Person:	Krupal Patel
	Job Title:	Senior Regulatory Specialist
	Email:	krupal.patel@zimmerbiomet.com
	Telephone:	(561) 776-6923
	Fax:	(561) 514-6316
II.	Proprietary Trade Name:	Eztetic™ BellaTek® Encode® Healing Abutments
III.	Device Classification Name:	Endosseous Dental Implant Abutment (21 CFR 872.3630)
IV.	Regulatory Class:	Class II
V.	Product Code:	NHA

VI. Predicate Devices:

Primary predicate device:

BellaTek® Encode® Healing Abutments referenced in Biomet 3i Dental Abutments and Restorative Components (K072642 / SE 12/20/2007)
Reference device:
. Healing Collars referenced in Zimmer 3.1mm Dental Implant System (K142082 / SE 07/28/2014)

VII. Product Description:

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VIII. Indications for Use:

IX. Summary of the Technological Characteristics:

The Eztetic™ BellaTek® Encode® Healing Abutments is available in 2.9mm restorative platform diameter, four heights: 3, 4, 6 and 8mm and two emergence profiles: 3.8 and 5mm. The height, emergence profile and the screw method of attachment with mating implant are same as primary predicate devices. The major change from the primary predicate device is the restorative platform diameter. However the restorative platform diameter is same as the reference device. The connection geometry of subject device is similar to reference device and they both engage Eztetic™ 3.1mm Dental Implant. The abutment form a passive or clearance fit within the implant internal connection. The retaining screw is used to secure the abutment to the implant. The abutment makes a flaton-flat engagement with top surface of the implant platform. A general device comparison of subject and predicate device is provided in table below.

Feature	Subject DeviceEztetic™ BellaTek®Encode® HealingAbutment	Primary PredicateDeviceBellaTek® Encode®Healing Abutment(K072642)	Reference DeviceHealing Collars(K142082)
Intended Use/Indications forUse	The Eztetic™BellaTek® Encode®Healing Abutmentsare intended for useas an accessory toendosseous dentalimplants duringendosseous andgingival healing toprepare gingivaltissue for acceptanceof a final abutmentand restoration.	Biomet 3i DentalAbutments are intendedfor use as accessories toendosseous dental implantto support a prostheticdevice in a partially orcompletely edentulouspatient. A dental abutmentis intended for use tosupport single andmultiple tooth prosthesis,in the mandible ormaxilla. The prosthesiscan be screw retained orcement retained to theabutment.Restorative Components:● Temporary Healing	Zimmer 3.1mmD DentalImplants are designed for usein the anterior maxilla ormandible for immediateloading or for loading after aconventional healing period.Implants may be used toreplace one or more missingteeth. Immediate loading isindicated when there is goodprimary stability and anappropriate occlusal load.Zimmer 3.1mmD DentalImplants may be placedimmediately following anextraction or loss of naturalteeth provided there issufficient volume of alveolarbone to minimally support the
	Subject Device	Primary PredicateDevice	Reference Device
Feature	Eztetic™ BellaTek®Encode® HealingAbutment	BellaTek® Encode®Healing Abutment(K072642)	Healing Collars(K142082)
		Abutments areintended for use toshape and maintainthe soft tissue openingduring healing.Castable restorativecomponents areintended for use asaccessories toendosseous dentalimplants to aid in thefabrication of dentalprosthetics. Screw components areintended for use asaccessories toendosseous dentalimplants for retentionof screw retainedabutments to thedental implant.	implant (minimum 1mmcircumferential and 2mmapical). The Zimmer 3.1mmDDental Implants should besplinted to additional implantswhen used in the pre-molarregion and should not be usedin the molar region.The 2.9mm Angled Abutmentand the 2.9mm AngledAbutment, Straight Hex areused for attachment ofrestorations requiring off-axiscorrection. The 2.9mm AngledAbutment and the 2.9mmAngled Abutment, StraightHex are designed to be used inedentulous or partiallyedentulous mandibles ormaxillae for attachment ofcomplete denture prostheses,or as a terminal orintermediary abutment forfixed or removablebridgework, or as afreestanding single toothreplacement.The 2.9mm Contour Abutmentand 2.9mm Contour AbutmentStraight Hex are used as aterminal or intermediateabutment for a cementedprosthesis. Abutment can beused for a single- or multiple-unit restoration. The 2.9mmAngled Contour Abutment and2.9mm Angled ContourAbutment, Straight Hex are
			designed to be used as a
Feature	Subject Device	Primary PredicateDevice	Reference Device
	EzteticTM BellaTek®Encode® HealingAbutment	BellaTek® Encode®Healing Abutment(K072642)	Healing Collars(K142082)
			terminal or intermediateabutment for a cementedprosthesis where the angleneeds to be offset by 17º.Abutment can be used for asingle-or multiple-unitrestoration.
			The 2.9mm TemporaryAbutment is intended to beused to fabricate and supportprovisional restorations thataid in creating an estheticemergence through the gingivaduring the healing period andprior to final restoration. The2.9mm Temporary Abutmentcan be used for cement-retained or screw-retainedprovisional restorations. Theabutments can be used forsingle-unit and multiple-unitrestorations.
			The Ball Abutment is used forretaining overdentures orpartial dentures whenresilience and facilitated oralhygiene are desired.
			The Healing Collar is used toassist in the forming of the softtissue during healing before afinal restoration is placed.
			The Healing Screw is used toseal the implant internalconnection and separate itfrom the soft tissue which issutured over the implant
Feature	Subject DeviceEztetic™ BellaTek®Encode® HealingAbutment	Primary PredicateDeviceBellaTek® Encode®Healing Abutment(K072642)	Reference DeviceHealing Collars(K142082)
			The Retaining Screws areintended to be used forsecuring the temporaryabutments, final abutments andimpression transfers to theimplant or implant analog. Thelong Retaining Screw isintended to be used withTemporary Abutments forfabrication of screw-retainedprovisional restorations andwith Impression Transfers fordirect impressions.
OperatingPrinciple	The Eztetic™BellaTek® Encode®Healing Abutmentaids in prostheticrehabilitation bysupporting thesurrounding gingivaltissue during thehealing period. Thehealing abutment isfixated on theimplant using aretaining screwimmediately afterimplant placementin a one-stagesurgical protocol. Ina two-stage surgicalprotocol, the healingabutment is fixatedon the implantfollowing the bonehealing period. Thesoft tissue is suturedaround the healingabutment and the	The BellaTek® Encode®Healing Abutment aids inprosthetic rehabilitationby supporting thesurrounding gingivaltissue during the healingperiod. The healingabutment is fixated on theimplant using a retainingscrew immediately afterimplant placement in aone-stage surgicalprotocol. In a two-stagesurgical protocol, thehealing abutment isfixated on the implantfollowing the bonehealing period. The softtissue is sutured aroundthe healing abutment andthe device remains in themouth until the soft tissuefully develops. Theocclusal surface of thedevice includes machinedmarkings that provideinformation about the	The Eztetic™ Healing Collaris designed to facilitategingival tissue healing. TheEztetic™ Healing Collar aidsin prosthetic rehabilitation bysupporting the surroundinggingival tissue during thehealing period. The soft tissueis sutured around the healingcollar and the device remainsin the mouth until the softtissue fully develops. Thehealing collar is threaded ontothe implant immediately afterimplant placement in a one-stage surgical protocol. In atwo-stage surgical protocol,the healing collar is threadedon the implant following thebone healing period.
	Subject Device	Primary PredicateDevice	Reference Device
Feature	Eztetic™ BellaTek®Encode® HealingAbutment	BellaTek® Encode®Healing Abutment(K072642)	Healing Collars(K142082)
	device remains inthe mouth until thesoft tissue fullydevelops. Theocclusal surface ofthe device includesmachined markingsthat provideinformation aboutthe mating implant'sposition andorientation.	mating implant's positionand orientation.
TechnologicalCharacteristics	Encode® CodingScheme (MachinedMarkings)	Encode® Coding Scheme(Machined Markings)	No Machined Markings
Method ofAttachment(Mating)	Attached to theimplant by aretaining screw	Attached to the implantby a retaining screw	Threads into implant
EmergenceProfile	3.8mm and 5.0mm	3.8mm - 7.5mm	3.7mm and 4.5mm
Height	3, 4, 6 and 8mm	3, 4, 6 and 8mm	1.5, 3.0 and 4.5mm
RestorativePlatformDiameter	2.9mm	3.4, 4.1, 5.0 and 6.0mm	2.9mm
ConnectionGeometry	Flat-to-flat matingwith a passive fitwithin the implantinternal connectionto engage Eztetic™3.1mm DentalImplant	Flat-to-flat mating with apassive fit within theimplant internalconnection to engageBiomet 3i External andInternal HexagonImplants	Flat-to-flat mating with apassive fit within the implantinternal connection to engageEztetic™ 3.1mm DentalImplant
Mating Implant	Zimmer Dental3.1mm Eztetic™Implant System	Biomet 3i Internal andExternal Hexagon ImplantSystem	Zimmer Dental 3.1mmEztetic™ Implant System
Packaging	Nylon Bag	Nylon Bag	Sealed Tray in an outerchipboard box
Materials	Titanium Alloy(Ti-6Al-4V ELI)	Titanium Alloy(Ti-6Al-4V ELI)	Titanium Alloy(Ti-6Al-4V ELI)
Feature	Subject DeviceEzteticTM BellaTek®Encode® HealingAbutment	Primary PredicateDeviceBellaTek® Encode®Healing Abutment(K072642)	Reference DeviceHealing Collars(K142082)
Sterilization	Gamma RadiationMethod	Gamma RadiationMethod	Gamma Radiation Method
Shelf Life	5 years	5 years	5 years
Single Use Only	Yes	Yes	Yes
Components/Accessories	NA	NA	NA

Table 1: General device comparison

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The Indications for Use for the subject device is specific to the healing abutment, therefore parts of the Indications for use for the predicate and reference devices that refer to the implants and abutments were omitted. The predicate submissions also included implants and abutments that were part of the dental implant system. These devices are not used for comparison since they have different indications for use as compared to subject devices. The primary predicate device is BellaTek® Encode® Healing Abutments referenced in Biomet 3i Dental Abutments and Restorative Components (K072642) and the reference device is Healing Collars referenced in Zimmer 3.1mm Dental Implant System (K142082).

X. Non-Clinical Testing:

The subject devices have less surface area and volume and are made out of identical materials as compared to previously tested Biomet 3i devices that were used for MR compatibility testing. Hence the MR testing data is leveraged and the subject devices are labeled as MR conditional.

Since the subject devices are manufactured out of identical materials and go through the identical manufacturing conditions, solvents and procedures as the primary predicate devices, the biocompatibility data of the primary predicate device was leveraged.

Sterilization is performed in the same manner as primary predicate devices. Sterilization is accomplished using gamma radiation at an exposure dose of 25 to 38 kGy and was validated under a dose setter using VDmax 3 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 level of 10° 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.

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The Eztetic " BellaTek® Encode Healing Abutments will maintain an identical five (5) year shelf-life as the primary and secondary predicate devices. 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.

The performance of the subject devices is determined by the material used to manufacture these devices and the structural integrity of the devices over the stated shelf-life. The material used for the subject devices (Ti-6A1-4V-ELI Titanium Alloy) have a shelf life much exceeding 5 years. The Titanium Alloy used to manufacture the subject devices is commonly used in medical devices and is stable at normal storage conditions. Per "ASTM F 136: Standard Specification for Wrought Titanium-6 Vanadium ELI Alloy"; this alloy composition has been employed successfully in human implant applications in contact with soft tissue and bone for over a decade. Therefore, a 5 year shelf life for the Eztetic" BellaTek® Encode® Healing Abutments can be substantiated and the device performance will be maintained for the entirety of the proposed shelf-life.

The changes in design from the primary predicate devices have been verified through bench testing studies. Torque to failure testing was performed on subject devices in the same manner as primary predicate devices in order to demonstrate that the retaining screw can withstand the recommended torque. Physical fit check evaluation was performed on subject devices in the same manner as primary predicate devices in order to assure that the device fits with the mating implant. Tolerance analysis was performed on subject devices in the same manner as primary predicate devices in order to assure that the entire tolerance range meets the design input. Print verification was performed on subject devices in the same manner as primary predicate devices in order to assure that the subject devices are properly constrained and accurately describe the intended original design. These studies have demonstrated that the subject devices are substantially equivalent to predicate devices.

XI. Conclusion:

The subject devices have demonstrated substantial equivalence to the predicate devices in that they have identical intended use, identical operating principle, identical materials and very similar fundamental designs.

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.)