Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a physical healing abutment made of titanium alloy and focuses on its mechanical properties, sterilization, and fit. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.

Therapeutic

No
The device is described as an accessory to prepare gingival tissue for acceptance of a final abutment and restoration, indicating a preparatory or facilitating role rather than directly treating a disease or condition.

Diagnostic

No

The device is described as a healing abutment intended to prepare gingival tissue for acceptance of a final abutment and restoration, which is a therapeutic rather than diagnostic function.

SaMD (Software as a Medical Device)

No

The device description explicitly states the device is made of Titanium Alloy and includes physical components (abutment and retaining screw). The performance studies focus on material properties, physical fit, and sterilization, indicating a hardware-based device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the device is an "accessory to endosseous dental implants during endosseous and gingival healing to prepare gingival tissue for acceptance of a final abutment and restoration." This describes a device used in vivo (within the body) for a mechanical and biological purpose related to dental surgery and healing.
Device Description: The description details a physical implant component made of titanium alloy, designed to be placed in the mouth.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) in vitro (outside the body) to provide information for diagnosis, monitoring, or compatibility testing.

IVD devices are specifically designed to perform tests on biological samples outside the body. This device is a surgical accessory used inside the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

NHA

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-Clinical Testing:

MR compatibility 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.
Biocompatibility: 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 validation: 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 10-6 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 studies: 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 material used for the subject devices (Ti-6Al-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.
Bench testing studies: 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K072642

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K142082

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.)

Summary

0

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.

1

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

2

INDICATIONS FOR USE

510(k) Number (if known): K170013

Device Name: Eztetic™ BellaTek® Encode® Healing Abutments

Indications for Use:

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.

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)

3

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:

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.

4

VIII. Indications for Use:

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.

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 Device
Eztetic™ BellaTek®
Encode® Healing
Abutment | Primary Predicate
Device
BellaTek® Encode®
Healing Abutment
(K072642) | Reference Device
Healing Collars
(K142082) |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use/
Indications for
Use | 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. | Biomet 3i Dental
Abutments are intended
for use as accessories to
endosseous dental implant
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 to the
abutment.
Restorative Components:
● Temporary Healing | Zimmer 3.1mmD Dental
Implants are designed for use
in the anterior maxilla or
mandible for immediate
loading or for loading after a
conventional healing period.
Implants may be used to
replace one or more missing
teeth. Immediate loading is
indicated when there is good
primary stability and an
appropriate occlusal load.
Zimmer 3.1mmD Dental
Implants may be placed
immediately following an
extraction or loss of natural
teeth provided there is
sufficient volume of alveolar
bone to minimally support the |
| | Subject Device | Primary Predicate
Device | Reference Device |
| Feature | Eztetic™ BellaTek®
Encode® Healing
Abutment | BellaTek® Encode®
Healing Abutment
(K072642) | Healing Collars
(K142082) |
| | | Abutments are
intended for use to
shape and maintain
the soft tissue opening
during healing.
Castable restorative
components are
intended for use as
accessories to
endosseous dental
implants to aid in the
fabrication of dental
prosthetics. Screw components are
intended for use as
accessories to
endosseous dental
implants for retention
of screw retained
abutments to the
dental implant. | implant (minimum 1mm
circumferential and 2mm
apical). The Zimmer 3.1mmD
Dental Implants should be
splinted to additional implants
when used in the pre-molar
region and should not be used
in the molar region.

The 2.9mm Angled Abutment
and the 2.9mm Angled
Abutment, Straight Hex are
used for attachment of
restorations requiring off-axis
correction. The 2.9mm Angled
Abutment and the 2.9mm
Angled Abutment, Straight
Hex are designed to be used in
edentulous or partially
edentulous mandibles or
maxillae for attachment of
complete denture prostheses,
or as a terminal or
intermediary abutment for
fixed or removable
bridgework, or as a
freestanding single tooth
replacement.

The 2.9mm Contour Abutment
and 2.9mm Contour Abutment
Straight Hex are used as a
terminal or intermediate
abutment for a cemented
prosthesis. Abutment can be
used for a single- or multiple-
unit restoration. The 2.9mm
Angled Contour Abutment and
2.9mm Angled Contour
Abutment, Straight Hex are |
| | | | designed to be used as a |
| Feature | Subject Device | Primary Predicate
Device | Reference Device |
| | EzteticTM BellaTek®
Encode® Healing
Abutment | BellaTek® Encode®
Healing Abutment
(K072642) | Healing Collars
(K142082) |
| | | | terminal or intermediate
abutment for a cemented
prosthesis where the angle
needs to be offset by 17º.
Abutment can be used for a
single-or multiple-unit
restoration. |
| | | | The 2.9mm Temporary
Abutment is intended to be
used to fabricate and support
provisional restorations that
aid in creating an esthetic
emergence through the gingiva
during the healing period and
prior to final restoration. The
2.9mm Temporary Abutment
can be used for cement-
retained or screw-retained
provisional restorations. The
abutments can be used for
single-unit and multiple-unit
restorations. |
| | | | The Ball Abutment is used for
retaining overdentures or
partial dentures when
resilience and facilitated oral
hygiene are desired. |
| | | | The Healing Collar is used to
assist in the forming of the soft
tissue during healing before a
final restoration is placed. |
| | | | The Healing Screw is used to
seal the implant internal
connection and separate it
from the soft tissue which is
sutured over the implant |
| Feature | Subject Device
Eztetic™ BellaTek®
Encode® Healing
Abutment | Primary Predicate
Device
BellaTek® Encode®
Healing Abutment
(K072642) | Reference Device
Healing Collars
(K142082) |
| | | | The Retaining Screws are
intended to be used for
securing the temporary
abutments, final abutments and
impression transfers to the
implant or implant analog. The
long Retaining Screw is
intended to be used with
Temporary Abutments for
fabrication of screw-retained
provisional restorations and
with Impression Transfers for
direct impressions. |
| Operating
Principle | The Eztetic™
BellaTek® Encode®
Healing Abutment
aids in prosthetic
rehabilitation by
supporting the
surrounding gingival
tissue during the
healing period. The
healing abutment is
fixated on the
implant using a
retaining screw
immediately after
implant placement
in a one-stage
surgical protocol. In
a two-stage surgical
protocol, the healing
abutment is fixated
on the implant
following the bone
healing period. The
soft tissue is sutured
around the healing
abutment and the | The BellaTek® Encode®
Healing Abutment aids in
prosthetic rehabilitation
by supporting the
surrounding gingival
tissue during the healing
period. The healing
abutment is fixated on the
implant using a retaining
screw immediately after
implant placement in a
one-stage surgical
protocol. In a two-stage
surgical protocol, the
healing abutment is
fixated on the implant
following the bone
healing period. The soft
tissue is sutured around
the healing abutment and
the device remains in the
mouth until the soft tissue
fully develops. The
occlusal surface of the
device includes machined
markings that provide
information about the | The Eztetic™ Healing Collar
is designed to facilitate
gingival tissue healing. The
Eztetic™ Healing Collar aids
in prosthetic rehabilitation by
supporting the surrounding
gingival tissue during the
healing period. The soft tissue
is sutured around the healing
collar and the device remains
in the mouth until the soft
tissue fully develops. The
healing collar is threaded onto
the implant immediately after
implant placement in a one-
stage surgical protocol. In a
two-stage surgical protocol,
the healing collar is threaded
on the implant following the
bone healing period. |
| | Subject Device | Primary Predicate
Device | Reference Device |
| Feature | Eztetic™ BellaTek®
Encode® Healing
Abutment | BellaTek® Encode®
Healing Abutment
(K072642) | Healing Collars
(K142082) |
| | device remains in
the mouth until the
soft tissue fully
develops. The
occlusal surface of
the device includes
machined markings
that provide
information about
the mating implant's
position and
orientation. | mating implant's position
and orientation. | |
| Technological
Characteristics | Encode® Coding
Scheme (Machined
Markings) | Encode® Coding Scheme
(Machined Markings) | No Machined Markings |
| Method of
Attachment
(Mating) | Attached to the
implant by a
retaining screw | Attached to the implant
by a retaining screw | Threads into implant |
| Emergence
Profile | 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 |
| Restorative
Platform
Diameter | 2.9mm | 3.4, 4.1, 5.0 and 6.0mm | 2.9mm |
| Connection
Geometry | Flat-to-flat mating
with a passive fit
within the implant
internal connection
to engage Eztetic™
3.1mm Dental
Implant | Flat-to-flat mating with a
passive fit within the
implant internal
connection to engage
Biomet 3i External and
Internal Hexagon
Implants | Flat-to-flat mating with a
passive fit within the implant
internal connection to engage
Eztetic™ 3.1mm Dental
Implant |
| Mating Implant | Zimmer Dental
3.1mm Eztetic™
Implant System | Biomet 3i Internal and
External Hexagon Implant
System | Zimmer Dental 3.1mm
Eztetic™ Implant System |
| Packaging | Nylon Bag | Nylon Bag | Sealed Tray in an outer
chipboard box |
| Materials | Titanium Alloy
(Ti-6Al-4V ELI) | Titanium Alloy
(Ti-6Al-4V ELI) | Titanium Alloy
(Ti-6Al-4V ELI) |
| Feature | Subject Device
EzteticTM BellaTek®
Encode® Healing
Abutment | Primary Predicate
Device
BellaTek® Encode®
Healing Abutment
(K072642) | Reference Device
Healing Collars
(K142082) |
| Sterilization | Gamma Radiation
Method | Gamma Radiation
Method | 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

5

6

7

8

9

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.

10

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.