Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a dental implant system and abutment, focusing on materials, mechanical properties, and sterilization. There is no mention of AI or ML in the intended use, device description, or performance studies.

Therapeutic

Yes
The device is intended to restore chewing function and support prosthetic devices, which aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.

Diagnostic

No

This device is intended to provide structural support for prosthetic devices (artificial teeth) and restore chewing function, not to diagnose a medical condition.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components made of Y-TZP and titanium alloy, intended for surgical implantation. This is a hardware device, not software.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use clearly states that the device is surgically placed in the bone to support prosthetic devices for restoring chewing function. This is an in vivo application, meaning it is used within a living organism.
Device Description: The description details the materials, manufacturing, and physical characteristics of the implant and abutment. It does not mention any components or processes related to testing samples of human origin outside the body.
Performance Studies: The performance studies focus on biocompatibility, mechanical testing, sterilization, bacterial endotoxin testing, MRI compatibility, and shelf life. These are all relevant to a surgically implanted device, not an IVD.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.

In summary, the Neodent Implant System and CR Abutment are medical devices intended for surgical implantation to restore function, which is the definition of an in vivo device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Indications for Use for Zirconia Implants:

The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage surgical procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with physiological occlusal loading. Multiple teeth applications can be rigidly splinted.

Indications for Use for CR Abutment for Zirconia System:

The CR Abutment is an abutment placed over Neodent Zirconia Implants in order to provide support for prosthetic restorations, such as copings or crowns. It may be used for single-unit restorations that are cement-retained in esthetical areas over implants installed in maxilla or mandible.

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

DZE, NHA

Device Description

Intended for single use;
Provided sterile via Ethylene Oxide;
. All devices of Zirconia Implant System are manufactured of Y-TZP (Yttrium-stabilized zirconium dioxide);
. The CR Abutment for Zirconia system is supplied along with a titanium alloy screw (ASTM F136);
ZiLock prosthetic interface with internal indexer;
Apically tapered implant with trapezoidal thread profile;
Implant provided with sand-blasted, acid etched surface finish;
. The subject Implants are compatible with the Zirconia Bases (already cleared per market per K201491) and CR Abutments (subject of this submission);
. The subject CR Abutments are compatible with the Zirconia Implants 4.3 mm (already cleared per market per K201491) and Zirconia Implants 3.75 mm (subject of this submission).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

bone of the upper or lower jaw

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)

Biocompatibility:

Biological Safety Assessment guided by ISO 10993-1
Chemical characterization was performed per ISO 10993-18.
Assessment determined that new biocompatibility tests were not needed as the subject devices do not represent a new worst case, relying on K201491 results.

Mechanical testing:

Dynamic fatigue test per ISO 14801 performed to determine fatigue strength. Key result: the tested subject devices exhibit a level of performance equivalent to that reviewed for the predicate devices.
Torsion Test performed to evaluate the Zirconia Implant System under static torsional loading.
Insertion test performed to evaluate the insertion torque of the Zirconia Implant System when inserted into sawbones material representing bone type I, II, III and IV.
SEM images made after fatigue loading test included to demonstrate that the subject devices present similar wear in the implant inner thread compared to the Zirconia Implant (K201491).
Screw torque testing performed with torque application and visual analysis before and after use to assess whether the torque would damage the items. Key result: No visible failure was identified after applying torque and removing items from the implant. The subject screws are considered equivalent to those already cleared per K201491.

Sterilization validation:

Sterilized by Ethylene Oxide, according to ISO 11135-1 via the over-kill method. Key result: The method achieved a Sterility Assurance Level of 1x10-6.
Assessment indicated subject devices do not represent new worst-cases for sterilization validation, adopting the method cleared under K201491.

Bacterial Endotoxin Testing:

Performed on representative samples selected and tested based upon raw material, manufacturing processes and sterilization process, according to ANSI/AAMI ST72:2011. Key result: The obtained results were

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

JJGC Industria e Comercio de Materiais Dentarios SA % Jennifer Jackson Director of Regulatory Affairs Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810

Re: K210336

Trade/Device Name: Neodent Implant System - Zirconia Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: July 14, 2021 Received: July 16, 2021

Dear Jennifer Jackson:

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.

1

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.

Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K210336

Device Name

Neodent Implant System - Zirconia Implant System

Indications for Use (Describe) Indications for Use for Zirconia Implants:

The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage surgical procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with physiological occlusal loading. Multiple teeth applications can be rigidly splinted.

Indications for Use for CR Abutment for Zirconia System:

The CR Abutment is an abutment placed over Neodent Zirconia Implants in order to provide support for prosthetic restorations, such as copings or crowns. It may be used for single-unit restorations that are cement-retained in esthetical areas over implants installed in maxilla or mandible.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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K210336 510(k) Summary

ADMINISTRATIVE INFORMATION

| Sponsor | JJGC Indústria e Comércio de Materiais Dentários SA
(dba Neodent)
Av. Juscelino Kubitschek de Oliveira, 3291
Curitiba, Parana, Brazil 81270-200
Registration No.: 3008261720
Owner/Operator No.: 10031702 |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Jennifer M. Jackson, MS
Director of Regulatory Affairs,
Straumann USA
E-mail: jennifer.jackson@straumann.com
Telephone (978) 747-2509 |
| Date Prepared | 13/Aug/2021 |
| Preparer / Alternate Contact | Mariana Soares Hartmann
Regulatory Affairs Analyst
JJGC Indústria e Comércio de Materiais Dentários SA
E-mail: mariana.hartmann@neodent.com |
| DEVICE NAME AND CLASSIFICATION | |
| Trade/ Proprietary Name
Common Name | Neodent Implant System – Zirconia Implant System
Endosseous dental implant
Endosseous dental implant abutment |
| Classification Name | Implant, Endosseous, Root-Form
Endosseous dental implant abutment |
| Classification Regulations
Product Code | 21 CFR 872.3640 / 21 CFR 872.3630, Class II
DZE/NHA |
| Classification Panel
Reviewing Branch | Dental Products Panel
Dental Devices Branch |
| PREDICATE DEVICE INFORMATION | |
| Primary Predicate Device | K201491 – Neodent Implant System – Zirconia Implant
System, JJGC Indústria e Comércio de Materiais
Dentários S.A |
| Reference Predicate Devices | K151328 - PURE Ceramic Implants - Institut Straumann
AG
K101945 - Neodent Implant System – CM Line, JJGC
Indústria e Comércio de Materiais Dentários S.A
K182620 - MRI Compatibility For Existing Neodent
Implant System, JJGC Indústria e Comércio de Materiais
Dentários S.A |

4

INDICATIONS FOR USE

Indications for Use for Zirconia Implants:

The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage surgical procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with physiological occlusal loading. Multiple teeth applications can be rigidly splinted.

Indications for Use for CR Abutment for Zirconia System:

The CR Abutment is an abutment placed over Neodent Zirconia Implants in order to provide support for prosthetic restorations, such as copings or crowns. It may be used for single-unit restorations that are cement-retained in esthetical areas over implants installed in maxilla or mandible.

SUBJECT DEVICE DESCRIPTIONS

Intended for single use;
Provided sterile via Ethylene Oxide;
. All devices of Zirconia Implant System are manufactured of Y-TZP (Yttrium-stabilized zirconium dioxide);
. The CR Abutment for Zirconia system is supplied along with a titanium alloy screw (ASTM F136);
ZiLock prosthetic interface with internal indexer;
Apically tapered implant with trapezoidal thread profile;
Implant provided with sand-blasted, acid etched surface finish;
. The subject Implants are compatible with the Zirconia Bases (already cleared per market per K201491) and CR Abutments (subject of this submission);
. The subject CR Abutments are compatible with the Zirconia Implants 4.3 mm (already cleared per market per K201491) and Zirconia Implants 3.75 mm (subject of this submission).

5

Neodent Implant System – Zirconia Implant System

TECHNOLOGICAL CHARACTERISTIC COMPARISON TABLES

	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE PREDICATE DEVICE
	Neodent Implant System - Zirconia Implant
System
Implants
JJGC Indústria e Comércio de Materiais
Dentários S.A.	K201491
Neodent Implant System - Zirconia Implant
System
Implants
JJGC Indústria e Comércio de Materiais
Dentários S.A.	K151328
PURE Ceramic Implants
Institut Straumann AG	Equivalence
Discussion
Indications for
Use	The Neodent Implant System is intended to
be surgically placed in the bone of the upper
or lower jaw to provide support for
prosthetic devices, such as artificial teeth, to
restore chewing function. It may be used
with single-stage or two-stage surgical
procedures, for single or multiple unit
restorations,
and
may
be
loaded
immediately when good primary stability is
achieved and with physiological occlusal
loading. Multiple teeth applications can be
rigidly splinted.	The Neodent Implant System is intended to
be surgically placed in the bone of the upper
or lower jaw to provide support for
prosthetic devices, such as artificial teeth, to
restore chewing function. It may be used
with single-stage or two-stage surgical
procedures, for single or multiple unit
restorations,
and
may
be
loaded
immediately when good primary stability is
achieved and with physiological occlusal
loading. Multiple teeth applications can be
rigidly splinted.	The Straumann® PURE Ceramic Implant
(Monotype) is indicated for restoration in
single tooth gaps and in an edentulous or
partially edentulous jaw. The prosthetic
restorations used are single crowns, fixed
partial or full dentures, which are connected
to the implants through the corresponding
components.
The Ø3.3 mm reduced diameter implants
are recommended for central and lateral
incisors only.	Identical
The Indications for Use of the subject
devices are the same as for the primary
predicate devices.
Implant-
Abutment
interface	Straight internal connection
indexing features (Zilock)	Straight internal connection
indexing features (Zilock)		Identical
Subject devices and Primary Predicate
devices present the same implant-
abutment interface.
Design	Apically Tapered format
Trapezoidal threads profile	Apically Tapered format
Trapezoidal threads profile		Identical
Subject devices and Primary Predicate
devices present the same design.
Reusable	No	No	No	Identical
The subject devices and the predicate devices
are indicated for single use.

Table 1. Technological Characteristic Comparison Table - Zirconia Implants

6

Traditional 510(k) Submission

Neodent Implant System - Zirconia Implant System
--------------------------------------------------	--	--	--	--

	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE PREDICATE DEVICE
	Neodent Implant System - Zirconia Implant
System
Implants
JJGC Indústria e Comércio de Materiais
Dentários S.A.	K201491
Neodent Implant System - Zirconia Implant
System
Implants
JJGC Indústria e Comércio de Materiais
Dentários S.A.	K151328
PURE Ceramic Implants
Institut Straumann AG	Equivalence
Discussion
Length (mm)	10; 11.5; 13	8; 10; 11.5; 13	8; 10; 12; 14 mm	Equivalent
Range of lengths for subject devices is
within the range of lengths for the predicate
devices.
Diameter (Ø)
(mm)	3.75 mm	4.3 mm	3.3; 4.1 mm	Equivalent
The diameter of the subject devices is
smaller than the diameter of the primary
predicate devices, but greater than the
reference predicate devices. Dynamic
Fatigue Testing were performed to ensure
the system strength.
Material	Yttrium-stabilized zirconium dioxide
(Y-TZP).	Yttrium-stabilized zirconium dioxide
(Y-TZP).	Yttrium-stabilized zirconium dioxide
(Y-TZP).	Identical
Subject devices and predicate devices are
manufactured of the same raw material.
Sterilization
Method	Provided sterile via Ethylene Oxide to an
SAL of 10-6.	Provided sterile via Ethylene Oxide to an SAL of
10-6.	Provided sterile via Ethylene Oxide to an SAL
of 10-6.	Identical
Subject devices and predicate devices a
provided sterilized by the same method.

7

Traditional 510(k) Submission

Neodent Implant System – Zirconia Implant System

	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE
	Neodent Implant System - Zirconia Implant
System
Implants
JJGC Indústria e Comércio de Materiais
Dentários S.A.	K201491
Neodent Implant System - Zirconia Implant
System
Implants
JJGC Indústria e Comércio de Materiais
Dentários S.A.	K101945
Neodent Implant System - CM Line
JJGC Indústria e Comércio de Materiais
Dentários S.A.
Indications for
Use	The CR Abutment is an abutment placed
over Neodent Zirconia Implants in order to
provide support for prosthetic restorations,
such as copings or crowns. It may be used
for single-unit restorations that are cement-
retained in esthetical areas over implants
installed in maxilla or mandible.	The Zirconia Base is an abutment placed
over Neodent Zirconia Implants in order to
provide support for custom-made
prosthetic restorations, such as copings or
crowns. It may be used for cement- or
screw-retained single unit restorations. All
digitally designed copings and/or crowns to
be used with the Neodent Zirconia Base
Abutment System are intended to be sent to
Straumann for manufacture at a validated
milling center.	The Neodent Implant System is intended to
be surgically placed in the bone of the upper
or lower jaw to provide support for
prosthetic devices, such as artificial teeth,
to restore chewing function. It may be used
with single-stage or two-stage procedures,
for single or multiple unit restorations, and
may be loaded immediately when good
primary stability is achieved and with
appropriate occlusal loading.	Equivalent
The Indications for the subject devices are
included within the scope of Indications for the
primary predicate devices. Both are indicated to
be placed over implants to support prosthetic
restorations such as copings or crowns and the
differences between the Indications for Use are
due to the fact that the predicate device is
digitally designed while the subject device is a
stock abutment.
Implant-
Abutment
interface	Straight internal connection
indexing features (Zilock)	Straight internal connection
indexing features (Zilock)	Cone morse internal connection	Identical
Subject devices and Primary Predicate devices
present the same implant-abutment interface.

Table 2. Technological Characteristic Comparison Table – Zirconia CR Abutments

8

Traditional 510(k) Submission

Neodent Implant System – Zirconia Implant System

| | SUBJECT DEVICE
Neodent Implant System - Zirconia Implant
System
Implants
JJGC Indústria e Comércio de Materiais | PRIMARY PREDICATE DEVICE
K201491
Neodent Implant System - Zirconia Implant
System
Implants
JJGC Indústria e Comércio de Materiais | REFERENCE PREDICATE DEVICE
K101945
Neodent Implant System - CM Line
JJGC Indústria e Comércio de Materiais
Dentários S.A. | EQUIVALENCE DISCUSSION |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Dentários S.A. | Dentários S.A. | | |
| Design | Angulation: 0; 17°
Gingival Height: 1.5; 2.5 mm
Platform: NP; SP | Angulation: 0
Gingival Height: 1.5; 2.5 mm
Platform: NP; SP | Angulation: 0, 17 and 30°
Gingival Height: 1.5; 2.5 and 3.5 mm | Equivalent
The angulation and gingival height of the
subject devices are within the range of
angulation and gingival height of the
reference predicate device (K101945) the
platform is identical of the primary
predicate device. |
| Reusable | No | No | No | Identical
The subject devices and the predicate devices
are intended for single use. |
| Material | Abutment: Yttrium-stabilized zirconium
dioxide
(Y-TZP).
Screw: Titanium alloy ASTM F136. | Abutment: Yttrium-stabilized zirconium
dioxide
(Y-TZP).
Screw: Titanium alloy ASTM F136. | Abutment and Screw: Titanium alloy ASTM
F136. | Identical
The subject devices have the same material of
construction as the primary predicate devices. |
| Sterilization
Method | Provided sterile via Ethylene Oxide to an SAL of
$10^{-6}$ | Provided sterile via Ethylene Oxide to an SAL of
$10^{-6}$ | Provided sterile via Ethylene Oxide to an SAL of
$10^{-6}$ | Identical
The subject devices have the same sterilization
method and same SAL as the predicate
devices. |

9

The subject implants have the same indications for use and an equivalent range of lengths as the primary predicate devices, being contemplated within the range of lengths of the predicate devices.

Subject and predicate implants have the same implant-to-abutment interface. Both present sand-blast and acid-etch surface finishes and same sterile barrier system. The subject implants are manufactured of the same materials and are sterilized using the same sterilization method as the primary predicate devices.

The subject CR Abutments have equivalent indications for use of the primary predicate devices and an equivalent range of gingival height and angulation as the reference predicate devices, being contemplated within the range of gingival height and diameter of the reference predicate devices. They also present the same sterilization method and are made of the same material as the primary predicate devices.

Overall, the subject devices are equivalent to the predicate devices as follows:

same intended use,
. same operating principle,
incorporate the same basic design,
incorporate the same materials, and
have same packaging and are sterilized using the same materials and processes

PERFORMANCE DATA

Biocompatibility

Representative samples of each of the subject devices was subjected to the following:

Biological Safety Assessment guided by ISO 10993-1,
Chemical characterization was performed per ISO 10993-18.

An assessment was made to define if new biocompatibility tests were needed or whether prior testing applies to the subject devices. The subject devices do not represent a new worst case and we are therefore relying on the results of the tests provided in K201491.

Mechanical testing

Dynamic fatigue test per ISO 14801 was performed to determine the fatigue strength for the dental implant system, according to FDA Guidance. The tested subject devices exhibit a level of performance equivalent to that reviewed for the predicate devices.

Torsion Test was performed to evaluate the Zirconia Implant System under static torsional loading.

Insertion test was performed to evaluate the insertion torque of the Zirconia Implant System when inserted into sawbones material representing bone type I, II, III and IV.

SEM images made after fatigue loading test were included to demonstrate that the subject devices present similar wear in the implant inner thread compared to the Zirconia Implant (K201491).

Screw torque testing was performed with torque application and visual analysis before and after use to assess whether the torque would damage the items. No visible failure was identified after applying torque

10

and removing items from the implant. The subject screws are considered equivalent to those already cleared per K201491.

Sterilization validation

The subject devices are sterilized by Ethylene Oxide, according to ISO 11135-1 via the over-kill method. The method achieved a Sterility Assurance Level of 1x10-6.

An assessment was made to determine if the subject devices represent new worst-cases for sterilization validation and since they do not represent a new worst-case, they are being adopted into the already the same sterilization validation method already cleared under K201491.

The Subject devices are not represented to be "pyrogen free".

Bacterial Endotoxin Testing are performed on representative samples selected and tested based upon the raw material, manufacturing processes and sterilization process, according to ANSI/AAMI ST72:2011, Bacterial Endotoxins – Test Methods, Routine Monitoring and Alternatives to Batch Testing. The obtained results were