Predicate Devices

Reference Devices

K150203, K150367, K153624, K163194, K173902, K190040, K190718, K191191, K192229

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a system of dental implants and abutments, including some digitally designed components, but there is no mention of AI or ML being used in the design, manufacturing, or function of the device. The performance studies focus on mechanical and biological safety testing.

Therapeutic

Yes.
The device is intended to restore chewing function by providing support for prosthetic devices such as artificial teeth, which is a therapeutic purpose.

Diagnostic

No

This device, the NUVO IF Implant System, is intended to provide support for prosthetic devices (like artificial teeth) to restore chewing function. It is a medical device used for treatment (restoration of function), not for diagnosing a condition.

SaMD (Software as a Medical Device)

No

The device description explicitly details physical components such as implants, cover screws, and abutments, which are hardware.

IVD (In Vitro Diagnostic)

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

Here's why:

Definition of IVD: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic, monitoring, or compatibility purposes.
Intended Use: The intended use of the NUVO IF Implant System and its associated components is to be surgically placed in the maxilla or mandible to support prosthetic devices for restoring chewing function. This is a surgical and prosthetic device, not a device used for examining specimens outside the body.
Device Description: The device description details implants, cover screws, and abutments made of titanium and other materials, designed for surgical implantation and prosthetic support. There is no mention of components or functions related to analyzing biological specimens.
Lack of IVD-related information: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples (blood, tissue, etc.)
- Diagnostic, monitoring, or compatibility testing
- Reagents or assays
- Measurement of biomarkers or other biological parameters

The device described is a dental implant system, which is a type of surgical and prosthetic medical device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Indications for Use for NUVO IF Implants and conventional abutments:
The NUVO IF Implant System is intended to be surgically placed in the maxilla or mandible to provide support for prosthetic devices such as artificial teeth in order to restore chewing function. It may be used with single-stage or twostage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly splinted.

The Titanium Temporary Abutment is indicated to provide temporary support for prosthesis structure for up to 6 months.

The Attachment Equator and Attachment Removable Prosthesis are indicated for the attachment of full or partial dentures to NUVO implants.

Indications for Use for Rotational and Anti-rotational Titanium Bases abutments:
Titanium Base Abutment is a titanium base placed onto dental implants to provide support for customized prosthetic restorations. It is used with a coping and crown, or crown alone, and is indicated for cement or screw-retained single or multi-unit restorations or screw-retained single restorations.

All digitally designed copings and/or crowns to be used with the Titanium Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.

The Rotational Titanium Base is indicated for cement or screw-retained multi-unit restorations.

Indications for Use for CARES® Abutment IF:
The CARES® Abutment is a customized prosthetic abutment, manufactured in titanium alloy, placed onto dental implants to provide support for customized prosthetic restorations (copings or crowns). It is indicated for cement-retained single restorations. All digitally designed abutments for use with the CARES® Abutment are intended to be sent to Straumann for manufacturing at a validated milling center.

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

DZE, NHA

Device Description

Implants

. Intended for single use;
Provided sterile via gamma irradiation
Manufactured of commercially pure titanium (Grade 4) per ASTM F67;
Bone level design
Apically tapered thread-form with apical cutting flutes in 3.5, 3.75 & 4.3 mm diameters with lengths of 7, 10, 11.5, 13, 16 & 18 mm and in 5.0 mm diameter with lengths of 7, 10, 11.5, 13 & 16 mm.
Provided with an internal hexagonal implant-to-abutment interface compatible with the subject Cover Screw and Abutments.

Cover Screws

Intended for single use;
Used to protect the internal geometry of the subject Nuvo IF implants during the healing phase when a two-stage protocol is used;
Placed out of occlusion;
Provided sterile via gamma irradiation in the same barrier package as the subject implants—also provided individually packaged in sterile condition via ethylene oxide gas;
Manufactured of titanium alloy (Ti6Al4V-ELI) per ASTM F136;
Provided with an implant-to-abutment interface compatible with the internal hexagonal geometry of the subject Nuvo IF implants.

Abutments

Intended for single use;
Provided sterile via ethylene oxide gas or non-sterile
Manufactured of titanium alloy (Ti6Al4V-ELI) per ASTM F136 or in a combination of POM (Polyoxymethylene) polymer and cobalt-chromium alloy (CoCr), conforming to ASTM F1537;
Conical format available in different diameters, height of cementable area and gingival height;
Screw-retained to the implant;
Provided with an implant-to-abutment interface compatible with the internal hexagonal geometry of the subject Nuvo IF implants;
Provided with coronal geometries in rotational (non-indexed) versions to support multiunit restorations and in anti-rotational (indexed) versions to support single restorations
Titanium Base abutments are two-piece abutments which are composed of a titanium base and a patient-specific CAD/CAM top-half, that when assembled together form the final finished device.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

maxilla or mandible

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)

Dynamic fatigue test per ISO 14801 and FDA guidance entitled Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments, issued on: May 12, 2004, was performed to determine the fatigue strength for the worst-case constructs assembled using the subject devices.

Sterilization of the subject endosseous dental implant devices via gamma irradiation was validated per ISO 11137-1 and ISO 11137-2. A minimum Sterility Assurance Level (SAL) of 1 x 10 ° has been validated.

Sterilization of the subject abutments via ethylene oxide gas was validated per ISO 11135. A minimum Sterility Assurance Level (SAL) of 1 x 10 ° has been validated.

Ethylene oxide residuals have been assessed per ISO 10993-7. Residuals are within accepted limits.

Sterilization of the subject abutments via moist heat was validated per ISO 17665-2. A minimum Sterility Assurance Level (SAL) of 1 x 10-6 has been validated.

Biological Safety Assessment guided by ISO 10993-1 and FDA guidance entitled Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" : Guidance for Industry and Food and Drug Administration Staff, issued June 16, 2016. Reference to previous biocompatibility testing is supplied as follows:
-Cytotoxicity testing was performed per ISO 10993-5.
-Chemical characterization was performed per ISO 10993-18.

Package transport integrity testing has been performed per ISTA 2A.

Product and package stability has been validated per ASTM F1980.

Product endotoxin testing (LAL) is performed monthly on products representative of the subject devices per ANSI/AAMI ST72.

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.

K101945

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.

K150203, K150367, K153624, K163194, K173902, K190040, K190718, K191191, K192229

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

§ 872.3640 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

0

Image /page/0/Picture/0 description: The image contains 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below it.

June 18, 2020

JJGC Indústria e Comércio de Materiais Dentários S.A. % Jennifer Jackson Director of Regulatory Affairs Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810

Re: K193234

Trade/Device Name: NUVO IF Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: May 19, 2020 Received: May 20, 2020

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,

for Srinivas Nandkumar, Ph.D. 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

2

Indications for Use

510(k) Number (if known) K193234

Device Name NUVO IF Implant System

Indications for Use (Describe)

Indications for Use for NUVO IF Implants and conventional abutments:

The NUVO IF Implant System is intended to be surgically placed in the maxilla or mandible to provide support for prosthetic devices such as artificial teeth in order to restore chewing function. It may be used with single-stage or twostage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly splinted.

The Titanium Temporary Abutment is indicated to provide temporary support for prosthesis structure for up to 6 months.

The Attachment Equator and Attachment Removable Prosthesis are indicated for the attachment of full or partial dentures to NUVO implants.

Indications for Use for Rotational and Anti-rotational Titanium Bases abutments:

Titanium Base Abutment is a titanium base placed onto dental implants to provide support for customized prosthetic restorations. It is used with a coping and crown, or crown alone, and is indicated for cement or screw-retained single or multi-unit restorations or screw-retained single restorations.

All digitally designed copings and/or crowns to be used with the Titanium Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.

The Rotational Titanium Base is indicated for cement or screw-retained multi-unit restorations.

Indications for Use for CARES® Abutment IF:

The CARES® Abutment is a customized prosthetic abutment, manufactured in titanium alloy, placed onto dental implants to provide support for customized prosthetic restorations (copings or crowns). It is indicated for cementretained single restorations. All digitally designed abutments for use with the CARES® Abutment are intended to be sent to Straumann for manufacturing at a validated milling center.

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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510(k) Summary

K193234

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	17 June 2020
Preparer / Alternate Contact	Luiza Vaccari Toppel
Regulatory Affairs Coordinator
JJGC Indústria e Comércio de Materiais Dentários SA
E-mail: luiza.toppel@neodent.com

DEVICE NAME AND CLASSIFICATION

Trade/ Proprietary Name	NUVO IF Implant System
Common Name	Endosseous dental implant
Classification Name(s)	Endosseous dental implant
Classification Regulation(s)	21 CFR 872.3640, Class II
Product Code(s)	DZE; NHA
Classification Panel	Dental Products Panel
Reviewing Branch	Dental Devices Branch

4

PREDICATE DEVICE INFORMATION

| Primary Predicate Device | K101945 – Neodent Implant System, JJGC Indústria e
Comércio de Materiais Dentários SA |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Reference Predicate Devices | K150203 – Medentika CAD/CAM Abuments, Medentika
GmbH
K150367 – Neodent Implant System, JJGC
K153624 – Neodent Implant System, JJGC
K163194 – Neodent Implant System - GM Line, JJGC
K173902 – Neodent Implant System - GM Line, JJGC
K190040 – Straumann BLX Line Extension - New
Abutments, Institut Straumann AG
K190718 – GM Zygomatic Implants, JJGC
K191191 – Neodent Implant System - Temporary
Abutments, JJGC
K192229 – Neodent Implant System – Neodent Titanium
Base for Bridge, JJGC |

INDICATIONS FOR USE

Indications for Use for NUVO IF Implants and conventional abutments:

The NUVO IF Implant System is intended to be surgically placed in the maxilla or mandible to provide support for prosthetic devices such as artificial teeth in order 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. Multiple tooth applications may be rigidly splinted.

The Titanium Temporary Abutment is indicated to provide temporary support for prosthesis structure for up to 6 months.

The Attachment Equator and Attachment Removable Prosthesis abutments are indicated for the attachment of full or partial dentures to NUVO implants.

Indications for Use for Rotational and Anti-rotational Titanium Bases abutments:

Titanium Base Abutment is a titanium base placed onto dental implants to provide support for customized prosthetic restorations. It is used with a coping and crown, or crown alone, and is indicated for cement-retained single or multi-unit restorations or screw-retained single restorations.

All digitally designed copings and/or crowns to be used with the Titanium Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.

The Rotational Titanium Base is indicated for cement or screw-retained multi-unit restorations.

Indications for Use for CARES® Abutment IF:

The CARES® Abutment is a customized prosthetic abutment, manufactured in titanium alloy, placed onto dental implants to provide support for customized prosthetic restorations (copings or crowns). It is indicated for screw-retained or cement-retained single restorations.

All digitally designed abutments for use with the CARES® Abutment are intended to be sent to Straumann for manufacturing at a validated milling center.

5

SUBJECT DEVICE DESCRIPTIONS

Implants

. Intended for single use;
Provided sterile via gamma irradiation
Manufactured of commercially pure titanium (Grade 4) per ASTM F67;
Bone level design
Apically tapered thread-form with apical cutting flutes in 3.5, 3.75 & 4.3 mm diameters with lengths of 7, 10, 11.5, 13, 16 & 18 mm and in 5.0 mm diameter with lengths of 7, 10, 11.5, 13 & 16 mm.
Provided with an internal hexagonal implant-to-abutment interface compatible with the subject Cover Screw and Abutments.

Cover Screws

Intended for single use;
Used to protect the internal geometry of the subject Nuvo IF implants during the healing phase when a two-stage protocol is used;
Placed out of occlusion;
Provided sterile via gamma irradiation in the same barrier package as the subject implants—also provided individually packaged in sterile condition via ethylene oxide gas;
Manufactured of titanium alloy (Ti6Al4V-ELI) per ASTM F136;
Provided with an implant-to-abutment interface compatible with the internal hexagonal geometry of the subject Nuvo IF implants.

Abutments

Intended for single use;
Provided sterile via ethylene oxide gas or non-sterile
Manufactured of titanium alloy (Ti6Al4V-ELI) per ASTM F136 or in a combination of POM (Polyoxymethylene) polymer and cobalt-chromium alloy (CoCr), conforming to ASTM F1537;
Conical format available in different diameters, height of cementable area and gingival height;
Screw-retained to the implant;
Provided with an implant-to-abutment interface compatible with the internal hexagonal geometry of the subject Nuvo IF implants;
Provided with coronal geometries in rotational (non-indexed) versions to support multiunit restorations and in anti-rotational (indexed) versions to support single restorations
Titanium Base abutments are two-piece abutments which are composed of a titanium base and a patient-specific CAD/CAM top-half, that when assembled together form the final finished device.

SUBSTANTIAL EQUIVALENCE COMPARISON TABLES

The Substantial Equivalence Comparison tables are provided on the pages that follow below.

6

Table 1. Substantial Equivalence -- Indication for Use Statements
	SUBJECT DEVICES	PRIMARY PREDICATE	REFERENCE PREDICATES
COMPARISON	K193234
NUVO IF Implant System
JJGC Indústria e Comércio de Materiais
Dentários S.A.	K101945
Neodent Implant System –
CM Alvim Implant System
JJGC Indústria e Comércio de
Materiais Dentários S.A.	K150367
Neodent Implant System –
TiBase & Preface
JJGC Indústria e Comércio de
Materiais Dentários S.A.	K163194
Neodent Implant System –
GM Line
JJGC Indústria e Comércio de
Materiais Dentários S.A.	K192229
Neodent Implant System –
GM Titanium Base for
Bridge
JJGC Indústria e Comércio de
Materiais Dentários S.A.	K191191
Neodent Implant System –
Temporary Abutments
JJGC Indústria e Comércio de
Materiais Dentários S.A.	K190040
Straumann® PUREloc
abutments
Institut Straumann AG
Indications
for Use
Statement	Indications for Use for NUVO IF Implants
and conventional abutments:
The NUVO IF Implant System is intended to
be surgically placed in the maxilla or
mandible to provide support for prosthetic
devices such as artificial teeth in order 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. Multiple
tooth applications may be rigidly splinted.

The Titanium Temporary Abutment is
indicated to provide temporary support for
prosthesis structure for up to 6 months.

The Attachment Equator and Attachment
Removable Prosthesis abutments are
indicated for the attachment of full or
partial dentures to NUVO implants.

Indications for Use for Rotational and Anti-
rotational Titanium Bases abutments:
Titanium Base Abutment is a titanium base
placed onto dental implants to provide
support for customized prosthetic
restorations. It is used with a coping and
crown, or crown alone, and is indicated for
cement-retained single or multi-unit
restorations or screw-retained single
restorations.

All digitally designed copings and/or
crowns to be used with the Titanium Base
Abutment System are intended to be sent | 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.
Multiple tooth applications
may be rigidly splinted. | Titanium Base Abutment is a
titanium base placed onto
Neodent dental implants to
provide support for
customized prosthetic
restorations. It is used with a
coping and crown, or crown
alone, and is indicated for
cement-retained single or
multi-unit restorations, or
screw-retained single
restorations.

PreFace Abutment is a
titanium abutment to be used
in fabricating a full custom
abutment and placed onto
Neodent dental implants to
provide support for
customized prosthetic
restorations.
PreFace Abutments are indicated for
screw-retained single
restorations or cement-
retained single or multi-unit
restorations. | Indications for Use for GM
implants and conventional
abutments:
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.

Indications for Use for GM
Titanium Base abutments:
Titanium Base Abutment is a
titanium base placed onto
Neodent dental implants to
provide support for
customized prosthetic
restorations. It is used with a
coping and crown, or crown
alone, and is indicated for
cement-retained single or
multi-unit restorations, or
screw-retained single
restorations.

All digitally designed copings
and/or crowns for use with
the Neodent Titanium Base | Titanium Base Abutment is a
titanium base placed onto
Neodent dental implants to
provide support for
customized prosthetic
restorations. It is used with a
coping and crown, or crown
alone, and is indicated for
cement-retained single or
multi-unit restorations or
screw-retained single
restorations.

All digitally designed copings
and/or crowns to be used with the
Neodent Titanium Base
Abutment System are
intended to be sent to
Straumann for manufacture
at a validated milling center.
The GM Titanium Base for
Bridge is indicated for
cement or screw-retained
multi-unit restorations. | 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.

The Neodent Implant System

Temporary Abutments are
indicated to be used on
Neodent implants to provide
temporary support for
prosthesis structure for up to
6 months. | The Straumann®
Retentive System is
indicated for the
attachment of full or
partial dentures on
Straumann implants |
| | SUBJECT DEVICES | PRIMARY PREDICATE | REFERENCE PREDICATES | | | | |
| COMPARISON | K193234
NUVO IF Implant System
JJGC Indústria e Comércio de Materiais
Dentários S.A. | K101945
Neodent Implant System -
CM Alvim Implant System
JJGC Indústria e Comércio de
Materiais Dentários S.A. | K150367
Neodent Implant System -
TiBase & Preface
JJGC Indústria e Comércio de
Materiais Dentários S.A. | K163194
Neodent Implant System -
GM Line
JJGC Indústria e Comércio de
Materiais Dentários S.A. | K192229
Neodent Implant System -
GM Titanium Base for
Bridge
JJGC Indústria e Comércio de
Materiais Dentários S.A. | K191191
Neodent Implant System -
Temporary Abutments
JJGC Indústria e Comércio de
Materiais Dentários S.A. | K190040
Straumann® PUREloc
abutments
Institut Straumann AG |
| | validated milling center.
The Rotational Titanium Base is indicated
for cement or screw-retained multi-unit
restorations.

Indications for Use for CARES® Abutment
IF:
The CARES® Abutment is a customized
prosthetic abutment, manufactured in
titanium alloy, placed onto dental implants
to provide support for customized
prosthetic restorations (copings or crowns).
It is indicated for screw-retained or
cement-retained single restorations.
All digitally designed abutments for use
with the CARES® Abutment are intended to
be sent to Straumann for manufacturing at | | | intended to be sent to
Straumann for manufacture
at a validated milling center.

Indications for Use for GM
Pro Peek Abutments:
The Pro PEEK Abutments are
indicated to be used on
Neodent implants to provide
temporary support for
prosthesis structure for up to
6 months. They can be used in
one or two stage procedures
and also immediate load when
there is good primary stability. | | | |

Table 1: Substantial Equivalence – Indication for Use Statements

7

8

The scope of the Indications for Use Statement for the subject devices (implants and conventional abutments section) are contained within the corresponding section of the Indications for Use Statement of the primary predicate device K101945. The specific languages for Titanium Temporary Abutment and Attachment Equator/Attachment Removable Prosthesis are the same of the corresponding section of the Indications for Use Statement of K191191 (Neodent Implant System - Temporary Abutments) and K190040 (Straumann® PUREloc abutments), except for the names of the devices.

The Indications for Use Statement for the subject device (Rotational and Anti-rotational Titanium Bases abutments section) is identical to the corresponding section of the Indications for Use Statement of K163194 (GM Titanium Base abutments section), except for the names of the devices. The specific indication for use for Titanium Base Rotational is the same of K192229 (Neodent Implant System - GM Titanium Base for Bridge).

The Indications for Use Statement for the subject device (CARES® Abutment IF section) is similar to the PreFace section of the Indications for Use Statement of the reference device K150367. The slight differences are the names of the devices and, for the subject device statement, the requirement to manufacture at a Straumann milling center. For K150367 the requirement to manufacture at a Straumann milling center was included in the labeling. The slight differences in wording between the Indications for Use Statements for the subject device and the reference device K150367 do not affect the intended use with dental implants for rehabilitation of the edentulous maxilla or mandible.

A comparison of the technological characteristics of the subject device and the predicate and reference devices is provided in the following table.

9

Table 2: Substantial Equivalence Comparison – Technological characteristics - Implants

	SUBJECT DEVICES	PRIMARY PREDICATE	REFERENCE PREDICATE
	K193234	K101945	K163194
COMPARISON	NUVO IF Implant System
JJGC Indústria e Comércio de Materiais
Dentários S.A.	Neodent Implant System - CM Line
JJGC Indústria e Comércio de Materiais
Dentários S.A.	Neodent Implant System - GM Line
JJGC Indústria e Comércio de Materiais
Dentários S.A.	EQUIVALENCE DISCUSSION
Implant Type	Bone Level	Bone Level		Same
The subject devices have the same external
design as the primary predicate.
Implant-to-
Abutment
Interface	Internal Hex	Cone Morse		Equivalent
The implant interface is equivalent to that of
the predicate. Dynamic fatigue testing has
been performed to establish the performance
of the interface.
Implant
Diameter	3.5 mm, 3.75 mm, 4.3 mm and 5.0 mm	3.5 mm, 4.3 mm and 5.0 mm	3.5 to 5.0 mm	Equivalent
The subject device diameters are in the range
of diameters of the primary and reference
predicate devices.
Implant Length	3.5 mm: 7, 10, 11.5, 13, 16 & 18 mm
3.75 mm: 7, 10, 11.5, 13, 16 & 18 mm
4.3 mm: 7, 10, 11.5, 13, 16 & 18 mm
5.0 mm: 7, 10, 11.5, 13 & 16 mm	Alvim CM Implant
All diameters: 8, 10, 11.5, 13 & 16 mm

10

Table 3: Substantial Equivalence Comparison – Traditional Abutments (Cover Screw/Healing Abutment/Multi-Unit Abutnent/Cement Retained Abutment)

11

12

13

Table 4: Substantial Equivalence Comparison – Technological characteristics – Traditional Abutments)

	SUBJECT DEVICES	REFERENCE PREDICATE	EQUIVALENCE DISCUSSION		SUBJECT DEVICES	PRIMARY PREDICATE	REFERENCE PREDICATES
	K193234	K191191		COMPARISON	K193234
NUVO IF Implant System
JJGC Indústria e Comércio de
Materiais Dentários S.A.	K101945
Neodent Implant System - CM
Alvim Implant System
JJGC Indústria e Comércio de
Materiais Dentários S.A.	K173902
Neodent Implant System - GM Line
JJGC Indústria e Comércio de
Materiais Dentários S.A.	K190040
Straumann BLX Line Extension -
New Abutments
Institut Straumann AG	EQUIVALENCE DISCUSSION
COMPARISON	NUVO IF Implant System
JJGC Indústria e Comércio de Materiais Dentários S.A.	Neodent Implant System - Temporary Abutments
JJGC Indústria e Comércio de Materiais Dentários S.A.		Equator Attachment	Equator Attachment IF	CM Mini Ball Attachment	GM Attachment Equator	Novaloc Abutments
Titanium Temporary	Titanium Temporary Abutment for Crown and for
Bridge	GM Temporary Abutment		Principal of operation	Abutment to accept detachable
over-denture prostheses.
Coronal Geometry: To accept
o-ring style matrices	Abutment to accept detachable
over-denture prostheses.
Coronal Geometry: To accept
o-ring style matrices	Abutment to accept detachable
over-denture prostheses.
Coronal Geometry: To accept o-
ring style matrices		Same
The principal of operation of
subject device is the same of the
primary predicate device.
Principal of operation	Abutment for the creation of a temporary, non-occlusal
restoration to address esthetics during fabrication of final
prosthesis.	Abutment for the creation of a temporary, non-occlusal
restoration to address esthetics during fabrication of final
prosthesis.	Same
The principal of operation of subject device is the same of
the primary predicate device.	Implant-to-Abutment
Interface	Internal Hex	Cone Morse	Cone Morse		Equivalent
The implant-to-abutment interface
is equivalent to that of the
reference predicate. Dynamic
fatigue testing is provided to
support the performance of the
subject Internal Hex interface.
Implant-to-Abutment
Interface	Internal Hex	Cone Morse	Equivalent
The implant interface is equivalent to that of the predicate.	Indexing	Non-indexed	Non-indexed	Non-indexed		Same
Indexing	Both Indexed and Non-indexed	Both Indexed and Non-indexed	Same	Diameter	Platform Ø: NP - 3.5 mm
SP - 4.5	Not Defined	Platform Ø: 3.5 to 5.0 mm		Equivalent
Subject devices are within the
range of reference predicate
devices diameters.
Diameter	Platform Ø:
NP – 3.5 mm
SP - 4.5 & 5.5 mm	Platform Ø: 3.5 mm, 4.5 mm	Equivalent
Subject device diameters are within the range of diameters
of the predicate devices or larger. Larger diameters do not
represent a worst case in terms of performance.	Gingival Height	NP – 1, 2, 3, 4 & 5 mm
SP – 1, 2, 3, 4 & 5 mm	1.5, 2.5, 3.5, 4.5 & 5.5 mm	1.5, 2.5, 3.5, 4.5 & 5.5 mm		Equivalent
Subject devices are included in the
range of the predicate devices
gingival heights.
Gingival Height	1.0 mm	0.8; 1.5; 2.5 and 3.5 mm	Equivalent
Subject device are included in the range of the predicate
device gingival heights.	Angulation	Straight	Straight	Straight		Same
Angulation	Straight	Straight	Same	Material	Titanium Alloy (Ti-6Al-4V)	Titanium Alloy (Ti-6Al-4V)	Titanium Alloy (Ti-6Al-4V)	Same
Material	Titanium Alloy (Ti-6Al-4V)	Titanium Alloy (Ti-6Al-4V)	Same	Surface Treatment	Machined with titanium nitride
coating	Machined	Machined with titanium nitride
coating		Equivalent
Subject devices and reference
predicate devices have the same
surface treatment
Surface Treatment	Machined (SP platform)
Machined and anodized (NP platform)	Machined	Equivalent
Anodized surface treatment is presented in other abutments
of primary predicate device K101945.	Single Use	Yes	Yes	Yes		Same
Duration of Use	Up to 6 months	Up to 6 months	Same	Sterilization Method	Ethylene Oxide to an SAL of
1×10-6	Ethylene Oxide to an SAL of 1x10-6	Ethylene Oxide to an SAL of 1x10-6		Same
Single Use	Yes	Yes	Same
Sterilization Method	Ethylene Oxide to an SAL of 1x10-6	Ethylene Oxide to an SAL of 1x10-6	Same

14

Table 5: Substantial Equivalence Comparison – Traditional Abutnents (Equator Attachment and Removable Prosthesis Attachment)

15

	SUBJECT DEVICES	PRIMARY PREDICATE	REFERENCE PREDICATES		EQUIVALENCE DISCUSSION
COMPARISON	K193234
NUVO IF Implant System
JJGC Indústria e Comércio de
Materiais Dentários S.A.	K101945
Neodent Implant System – CM
Alvim Implant System
JJGC Indústria e Comércio de
Materiais Dentários S.A.	K173902
Neodent Implant System - GM Line
JJGC Indústria e Comércio de
Materiais Dentários S.A.	K190040
Straumann BLX Line Extension -
New Abutments
Institut Straumann AG
Removable Prosthesis
Attachment	Removable Prosthesis
Attachment IF	CM Mini Ball Attachment	GM Attachment Equator	Novaloc Abutments
Principal of operation	Abutment to accept detachable
over-denture prostheses.	Abutment to accept detachable
over-denture prostheses.	Abutment to accept detachable
over-denture prostheses.	Abutment to accept detachable
over-denture prostheses.	Same
The principal of operation of subject
device is the same of the primary
predicate device.
Design	Coronal Geometry: To accept
Valoc Novaloc matrices	Coronal Geometry: To accept o-
ring style matrices	Coronal Geometry: To accept o-
ring style matrices	Coronal Geometry: To accept
Valoc Novaloc matrices	Equivalent
Subject devices and reference
predicates per K190040 have same
intended use and similar coronal
geometry (differing gingival heights
are not significant to performance).
Implant-to-Abutment
Interface	Internal Hex	Cone Morse	Cone Morse	Straumann BLX	Equivalent
The implant interface is equivalent
to that of the predicate.
Indexing	Non-indexed	Non-indexed	Non-indexed	Indexed	Same
Diameter	Platform Ø: NP - 3.5 mm
SP - 4.5	Not Defined	Platform Ø: 3.5 to 5.0 mm	4.5 mm	Equivalent
Subject devices are within the range
of reference predicate devices
diameters.
Gingival Height	NP - 1, 2, 3, 4 & 5 mm
SP - 1, 2, 3, 4 & 5 mm	1.5, 2.5, 3.5, 4.5 & 5.5 mm	1.5, 2.5, 3.5 ,4.5 & 5.5mm	1.5 to 6.5 mm	Equivalent
Subject devices are included in the
range of the predicate devices
gingival heights.
Angulation	Straight	Straight	Straight	Straight and Angulated	Same
Material	Titanium Alloy (Ti-6Al-4V)	Titanium Alloy (Ti-6Al-4V)	Titanium Alloy (Ti-6Al-4V)	Titanium Alloy (Ti-6Al-4V)	Same
Surface Treatment	Machined and titanium nitride
coating	Machined and titanium nitride
coating	Machined and titanium nitride
coating	Machined and titanium nitride
coating	Equivalent
Subject devices and reference
predicate devices have the same
surface treatment
Single Use	Yes	Yes	Yes	Yes	Same
COMPARISON	SUBJECT DEVICES	PRIMARY PREDICATE	REFERENCE PREDICATES		EQUIVALENCE DISCUSSION
	K193234
NUVO IF Implant System
JJGC Indústria e Comércio de
Materiais Dentários S.A.	K101945
Neodent Implant System – CM
Alvim Implant System
JJGC Indústria e Comércio de
Materiais Dentários S.A.	K173902
Neodent Implant System - GM Line
JJGC Indústria e Comércio de
Materiais Dentários S.A.	K190040
Straumann BLX Line Extension -
New Abutments
Institut Straumann AG
Sterilization Method	Ethylene Oxide to an SAL of
$1 \times 10^{-6}$	Ethylene Oxide to an SAL of $1 \times 10^{-6}$	Ethylene Oxide to an SAL of $1 \times 10^{-6}$	Non-Sterile	Same
	SUBJECT DEVICES	PRIMARY PREDICATE	REFERENCE PREDICATE
COMPARISON	K193234
NUVO IF Implant System
JJGC Indústria e Comércio de Materiais
Dentários S.A.	K101945
Neodent Implant System - CM Alvim
Implant System
JJGC Indústria e Comércio de Materiais
Dentários S.A.	K173902
Neodent Implant System - GM Line
JJGC Indústria e Comércio de Materiais
Dentários S.A.	EQUIVALENCE DISCUSSION
UCLA CoCr	UCLA CoCr IF	Not applicable	GM Exact Co-Cr Abutment for Crown
Principal of operation	Abutment to facilitate the casting of base
metal and precious metal alloy prostheses.		Abutment to facilitate the casting of base
metal and precious metal alloy prostheses.	Same
The principal of operation of subject device
is the same of the reference predicate
device.
Implant-to-Abutment
Interface	Internal Hex	Cone Morse	Cone Morse	Equivalent
The implant interface is equivalent to that of
the predicate.
Indexing	Both Indexed and Non-indexed		Non-indexed	Equivalent
The subject devices indexing is the
equivalent of reference predicate devices.
The indexed devices are presented in other
primary predicate devices.
Diameter	Platform Ø: NP – 3.5 mm
SP - 4.5 & 5.5 mm		Platform Ø: 3.5 to 6.0 mm	Equivalent
Subject devices are within the range of
reference predicate devices diameters.
Gingival Height	NP - 1, 2, 3, 4 & 5 mm
SP - 1, 2, 3, 4 & 5 mm		1 mm	Equivalent
The different gingival heights do not
introduce a new worst in terms of
performance.
Angulation	Straight		Straight	Same
The subject devices and the predicate
devices are straight.
Material	CoCr Alloy with POM polymer		CoCr Alloy with POM polymer	Same
Subject, primary and reference predicate
devices have the same material of
construction.
Surface Treatment	Machined and anodized (only NP
platform)		Machined	Same
Anodized surface treatment is presented in
other abutments of primary predicate device
K101945.
Single Use	Yes	Yes	Yes	Same
	SUBJECT DEVICES	PRIMARY PREDICATE	REFERENCE PREDICATE
COMPARISON	K193234
NUVO IF Implant System
JJGC Indústria e Comércio de Materiais
Dentários S.A.	K101945
Neodent Implant System – CM Alvim
Implant System
JJGC Indústria e Comércio de Materiais
Dentários S.A.	K173902
Neodent Implant System - GM Line
JJGC Indústria e Comércio de Materiais
Dentários S.A.	EQUIVALENCE DISCUSSION
Sterilization Method	Provided non-sterile. Terminally sterilized by
the user via moist heat. Moist heat cycle
parameters have been validated to an SAL of
$1 x 10^{-6}$ .		Provided non-sterile. Terminally sterilized by
the user via moist heat. Moist heat cycle
parameters have been validated to an SAL of
$1 x 10^{-6}$ .	Same
Subject and reference predicate device
utilize the same sterilization method and
minimum SAL.

16

17

Table 6: Substantial Equivalence Comparison – Technological characteristics – Traditional Abutments (UCLA CoCr)

18

19

Table 7: Substantial Equivalence Comparison – CADCAM Abutments (Anti-Rotational Titanium Base IF)

	SUBJECT DEVICES	REFERENCE PREDICATES
COMPARISON	K193234
NUVO IF Implant System
JJGC Indústria e Comércio de Materiais
Dentários S.A.	K150367 & K153624
Neodent Implant System
JJGC Indústria e Comércio de Materiais
Dentários S.A.	K163194
Neodent Implant System - GM Line
JJGC Indústria e Comércio de Materiais
Dentários S.A.	EQUIVALENCE DISCUSSION
Anti-Rotational
Titanium Base IF	Anti-Rotational Titanium Base IF	Titanium Base Abutment	GM Exact Titanium Base
Principal of
operation	Abutment designed to accept a cement-
retained prosthetic.

Titanium Base abutments are two-piece
abutments which are composed of a
titanium base and a patient-specific
CAD/CAM top-half, that when assembled | Abutment designed to accept a cement-
retained single or multi-unit restorations, or
screw-retained single restorations.

Titanium Base abutments as two-piece
abutments which are composed of a titanium
base and a patient-specific CAD/CAM top- | Screw-retained single-unit, or Cement-
retained single or multi-unit.

20

21

Table 8: Substantial Equivalence Comparison – CADCAM Abutments (Rotational Titanium Base IF)

COMPARISON	SUBJECT DEVICES	REFERENCE PREDICATE	EQUIVALENCE DISCUSSION
	K193234	K192229
	NUVO IF Implant System	Neodent Implant System - GM Titanium Base for Bridge
	JJGC Indústria e Comércio de Materiais Dentários S.A.	JJGC Indústria e Comércio de Materiais Dentários S.A.
Rotational Titanium
Base IF	Rotational Titanium Base IF	GM Titanium Base for Bridge
Principal of
operation	Abutment designed to accept a cement or screw-retained
prosthetic.	Abutment designed to accept a cement or screw-retained
prosthetic.	Same
	Titanium Base abutments as two-piece abutments which
are composed of a titanium base and a patient-specific
CAD/CAM top-half, that when assembled together form
the final finished device.	Titanium Base abutments as two-piece abutments which are
composed of a titanium base and a patient-specific CAD/CAM
top-half, that when assembled together form the final
finished device.
Implant-to-
Abutment Interface	Internal Hex	Cone Morse	Equivalent
The implant interface is equivalent to that of the predicate.
Indexing	Non-Indexed	Non-Indexed	Same
Diameter	Platform Ø: NP – 3.5
SP – 4.5 & 5.5 mm	Platform Ø: 3.5, 4.5, and 5.5 mm	Equivalent
Subject device diameters are within the range of diameters of
the predicate devices or larger. Larger diameters do not
represent a worst case in terms of performance.
Gingival Height	NP – 0.5, 1 & 3 mm
SP – 0.5, 1 & 3 mm	0.8, 1.5, 2.5, 3.5 & 4.5 mm	Equivalent
Subject devices are included in the range of the predicate
device gingival heights.
Angulation	Straight	Straight	Same
CAD/CAM
Restoration
Angulation	Up to 30°	Up to 30°	Same
CAM/CAM material
superstructure	Titanium (brand name (ticon)	Titanium (brand name ticon)	Same
	Cobalt-chromium (brand name coron)	Cobalt-chromium (brand name coron)
	Zirconia (brand name zerion LT)	Zirconia (brand name zerion LT)
Abutment Material	Titanium Alloy (Ti-6Al-4V)	Titanium Alloy (Ti-6Al-4V)	Same
Surface Treatment	Machined and anodized (only NP platform)	Machined	Equivalent
Anodized surface treatment is presented in other abutments
of K101945.
Single Use	Yes	Yes	Same
COMPARISON	SUBJECT DEVICES		EQUIVALENCE DISCUSSION
	K193234
NUVO IF Implant System
JJGC Indústria e Comércio de Materiais Dentários S.A.	K192229
Neodent Implant System – GM Titanium Base for Bridge
JJGC Indústria e Comércio de Materiais Dentários S.A.
Sterilization Method	Ethylene Oxide to an SAL of 1x10-6	Ethylene Oxide to an SAL of 1x10-6	Same
	SUBJECT DEVICES	REFERENCE PREDICATE
COMPARISON	K193234	K150367	EQUIVALENCE DISCUSSION
	NUVO IF Implant System	Neodent Implant System - Titanium Base & Preface
	JJGC Indústria e Comércio de Materiais Dentários S.A.	JJGC Indústria e Comércio de Materiais Dentários S.A.
CARES® Abutment	CARES® Abutment IF	PreFace Abutment
IF
Principal of	Milling blank with the Implant-to-Abutment interface pre-
milled at one end. Used to fabricate patient-specific
abutments that are indicated with screw-retained or
cement-retained single restorations	Milling blank with the Implant-to-Abutment interface pre-
milled at one end. Used to fabricate patient-specific
abutments that are indicated with screw-retained single
restorations or cement-retained single or multi-unit
restorations.	Equivalent
The principal of operation of subject device is with the
reference predicate device.
operation
Implant-to-	Internal Hex	Cone Morse	Equivalent
The implant interface is equivalent to that of the predicate.
Abutment Interface
Indexing	Indexed	Indexed	Same
Diameter	Oversize cylinder for milling 11.5 mm & 15.8 mm
diameters

Platform Ø: NP - 3.5
SP - 4.5 | Oversize cylinder for milling 11.5 mm & 15.8 mm
diameters

22

23

Table 9: Substantial Equivalence Comparison – CADCAM Abutments (CARES® Abutment IF)

24

PERFORMANCE DATA

Dynamic fatigue test per ISO 14801 and FDA guidance entitled Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments, issued on: May 12, 2004, was performed to determine the fatigue strength for the worst-case constructs assembled using the subject devices.

Sterilization of the subject endosseous dental implant devices via gamma irradiation was validated per ISO 11137-1 and ISO 11137-2.

A minimum Sterility Assurance Level (SAL) of 1 x 10 ° has been validated.

Sterilization of the subject abutments via ethylene oxide gas was validated per ISO 11135. A minimum Sterility Assurance Level (SAL) of 1 x 10 ° has been validated.

Ethylene oxide residuals have been assessed per ISO 10993-7. Residuals are within accepted limits.

Sterilization of the subject abutments via moist heat was validated per ISO 17665-2. A minimum Sterility Assurance Level (SAL) of 1 x 10-6 has been validated.

Biological Safety Assessment guided by ISO 10993-1 and FDA guidance entitled Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" : Guidance for Industry and Food and Drug Administration Staff, issued June 16, 2016. Reference to previous biocompatibility testing is supplied as follows:

-Cytotoxicity testing was performed per ISO 10993-5.
-Chemical characterization was performed per ISO 10993-18.

Package transport integrity testing has been performed per ISTA 2A.

Product and package stability has been validated per ASTM F1980.

Product endotoxin testing (LAL) is performed monthly on products representative of the subject devices per ANSI/AAMI ST72.

CONCLUSION

The subject devices and the identified primary and reference predicate devices have intended use, similar designs and technological characteristics same sterilization methods and are made of the same materials. The data included in this submission demonstrate that the subject devices are substantially equivalent to the identified predicate devices.