Predicate Devices

Reference Devices

K150182, K153624, K093027, K151455, K130808, K061804

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes dental implants and abutments, focusing on materials, design, and mechanical properties. 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 provide support for prosthetic devices, which are therapeutic actions.

Diagnostic

No

Explanation: The Neodent Implant System and its components are intended for surgical placement in bone to support dental prosthetics and restore chewing function. Their purpose is therapeutic and restorative, not diagnostic.

SaMD (Software as a Medical Device)

No

The device description clearly details various physical components made of titanium and PEEK, including implants, abutments, screws, and cylinders. While it mentions digitally designed components being sent for manufacturing, the core device is a system of physical implants and prosthetic components.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Description and Intended Use: The description and intended use clearly state that this device is a dental implant system designed to be surgically placed in the bone of the jaw to support prosthetic devices. It is a physical implant and associated components used in vivo (within the body).
No Mention of Samples or Testing: The text does not mention any analysis of biological samples or diagnostic testing.

Therefore, this device falls under the category of a surgical implant and prosthetic support system, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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 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 Abutment System are 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.

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

DZE, NHA

Device Description

The GM Line of the Neodent Implant System (GM Line) consists in an expansion of the Neodent Implant System previously cleared under K101945, K150182 and K153624, presenting a new design of Morse taper implant-to-abutment interface trade named GM line.

The GM line comprises a range of endosseous dental implants as well as conventional and CAD/CAM abutments described as follows:

The GM Line dental implants are threaded, self-tapping, root form with a Morse taper implantto-abutment interface with an internal hexagonal index exclusive to the GM line. They are made of titanium grade 4 conforming to ASTM F67. They are available in two types of surface treatment:

NeoPoros: rough surface created using an abrasive particle jet concept with controlled grain oxides, followed by acid etching creating uniform cavities in the implant surface.

Acqua: hydrophilic surface created from Neoporos rough surface that undergoes additional processing that renders hydrophilic surface.

GM Titamax implants

The GM Titamax implants have cylindrical shape with double threads of pyramidal profile, rounded apex and are available in diameters of 3.5, 3.75 and 4.0 mm with lengths of 7, 8, 9, 11, 13, 15 and 17 mm, and in 5.0 mm diameter with lengths of 7, 8, 9, 11 and 13 mm. They are recommended for surgical intraoral installation in bone of type I or II.

GM Helix implants

The GM Helix implants have a conical shape, double threads with trapezoidal profile, a rounded apex and are available in diameters of 3.5, 3.75, 4.0, 4.3 and 5.0 mm with lengths of 8, 10, 11.5, 13, 16 and 18 mm. They are recommended for surgical intraoral installation in bones types III or IV, or in bone of type I and II when using conical drills.

GM Drive implants

The GM Drive implants have conical shape with double and progressive threads, cutting chambers in the counterclockwise direction, blade-shaped apical thread, rounded apex and are available in diameters of 3.5, 4.3 and 5.0 mm with lengths of 8, 10, 11.5, 13, 16 and 18 mm. They are recommended for surgical intraoral installation in bone of type III or IV.

The GM Line dental abutments are made of titanium alloy conforming to ASTM F136 and have a machined surface. The abutments are intended to be placed directly onto implants and are recommended according to the available interocclusal space, gingival height, and threedimensional position of the implant. They can be used in immediate or conventional rehabilitation procedures on the maxilla or mandible.

GM Cover Screws

The GM Cover Screws are devices for temporary use during the implant healing phase. They are available in two different heights: at the level of the platform (for use on implants placed at the bone level) and with a gingival height of 2 mm (for use on implants placed up to 2 mm infraosseous). The GM Cover Screws are indicated for use during the osseointegration phase, on Neodent implants to be rehabilitated using the late loading technique. Cover Screws should remain intramucosal, impeding tissue grown over the platform of the implant. Cover Screws are placed out of occlusion.

GM Healings

The GM Healing Abutments are devices for temporary use. They are available in diameters of 3.3 and 4.5 mm and the following gingival heights: 0.8, 1.5, 2.5, 3.5, 4.5, 5.5 mm. They are indicated for maintenance of the soft tissue during the osseointegration phase of Neodent implant to be rehabilitated using the late loading technique. They can be used on the insertion of the Implant or re-opening surgery (second surgical phase). Healing Abutments are placed out of occlusion.

GM Micro Abutments / GM Mini Conical Abutment / GM Exact Mini Conical Abutment

They are intermediary prosthetic components to be installed onto GM implants to support the final prosthesis. They are provided in a rotational shape for the coupling with the prosthesis and in different gingival heights to match the variations in mucosal thickness. The GM Exact Mini Conical abutment is provided angled. They are indicated for screw-retained multiple-unit prostheses onto implants. The GM Micro Abutment, when used with the anti-rotational coping, is also indicated for single-tooth prosthesis.

GM Exact Abutments

GM Exact abutments are intermediary prosthetic components to be installed onto GM implants to support the final prosthesis. They are provided in an anti-rotational shape for the coupling with the prosthesis and are available in 3.5 and 4.8 mm of diameter and the following gingival heights: 0.8, 1.5, 2.5, 3.5, 4.5, 5.5 mm. They are indicated for screw-retained single-tooth prostheses onto implants.

GM Exact Click Universal Abutments (straight and angled)

GM Exact Click Universal abutments are intermediary prosthetic components to be installed onto GM implants to support the final prosthesis. They provided in an anti-rotational shape for the coupling with the prosthesis and in various angulation, prosthetic and gingival heights to match the variation in mucosal thickness. They are indicated for cemented-retained single-tooth prostheses onto implants.

GM Exact Titanium Base abutments

The Titanium Bases are intermediary prosthetic components to be installed onto GM implants to support the final prosthesis; the Titanium Base two-piece abutments used as a base when fabricating a CAD/CAM customized restoration. They are provided in an anti-rotational shape for the coupling with the prosthesis and are available in diameters of 3.5 and 4.5 mm and the following gingival heights: 0.8, 1.5, 2.5, 3.5, 4.5, 5.5 mm. The planning and milling of the customized superstructures must be made using the validated Dental Wings Operating System (DWOS) or 3Shape software. All digitally designed copings and/or crowns for use with the Titanium Bases are intended to be manufactured at a validated milling center. The limits for customization are stated in product IFU. The superstructure produced through CAD/CAM System will compose the second part of the two-piece abutment; the assembly becomes a finished medical device after cementation on Titanium Base. They are indicated cementedretained single-tooth prostheses onto implants.

GM Pro PEEK Abutment

GM Pro PEEK abutments are temporary intermediary prosthetic components to be installed onto the Implants to support the provisional prosthesis up to 6 months. They are composed of a customizable cylindrical body made of PEEK and a non-customizable base made of titanium alloy for an anti-rotational implant connection to GM implants. They are available in 4.5 and 6.0 mm of diameter and the following gingival heights: 0.8, 1.5, 2.5, 3.5, 4.5, 5.5 mm. Pro PEEK Abutments can be used before the installation of the final prosthesis to maintain, stabilize and shape the soft tissue (gum) during the healing phase. Pro PEEK Abutment must not be placed in occlusion when assembled with small diameter implants (

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/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, with flowing lines connecting them, representing health and well-being.

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

July 14, 2017

JJGC Industria e Comercio de Materiais Dentarios SA c/o Jennifer Jackson Director, Regulatory Affairs & Quality Management Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810

Re: K163194

Trade/Device Name: Neodent Implant System - GM Line Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: June 13, 2017 Received: June 15, 2017

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. 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

1

Page 2 - Jennifer Jackson

Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related 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.

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 -A

Lori A. Wiggins, MPT, CLT 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K163194

Device Name

Neodent Implant System - GM Line

Indications for Use (Describe)

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 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 Abutment System are 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.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

3

510(k) Summary

| Submitter | Straumann USA, LLC
60 Minuteman Road
Andover, MA 01810
Registration No.: 1222315
Owner/Operator No.: 9005052 |
|------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | on behalf of:
JJGC Indústria e Comércio de Materiais Dentários SA
Av. Juscelino Kubitschek de Olivera, 3291
Curtiba, Parana, BRAZIL 81270-200
Registration No.: 3008261720
Owner/Operator No.: 10031702 |
| Contact Person | Jennifer M. Jackson, MS
Director, Regulatory Affairs & Quality, Straumann USA
E-Mail: jennifer.jackson@straumann.com
Telephone (978) 747-2509 |
| Date Prepared | 14/Jul/2017 |
| Prepared by | Ana Carolina Martins Vianna
RA & Compliance Manager, Institut Straumann AG
ana.vianna@straumann.com |
| Product Code
Device Class
Classification Panel | DZE (21 CFR 872.3640) / NHA
II
Dental |
| Classification Name | Root-form endosseous dental implant (21 CFR 872.3640) |
| Common Name | Root-form endosseous dental implant |
| Proprietary name | Neodent Implant System - GM Line |
| Primary Predicate | K101945 - Neodent Implant System, JJGC Indústria e Comércio de
Materiais Dentários SA |
| Reference Predicate
Devices | K150182 - Neodent Implant System - CM Drive line extension,
JJGC Indústria e Comércio de Materiais Dentários SA
K153624 - Neodent Implant System, JJGC Indústria e Comércio de
Materiais Dentários SA
K093027 – Straumann RC Temporary Abutments, Institut
Straumann AG
K151455 – 3Shape Abutment Designer Software, 3Shape A/S
K130808 - Straumann Healing Abutments, Healing Caps and
Closure Screws, Institute Straumann AG
K061804 - Zerion Alpha, Zerion Beta, ETKON International, Gmbh |

4

5.1 Device Description

The GM Line of the Neodent Implant System (GM Line) consists in an expansion of the Neodent Implant System previously cleared under K101945, K150182 and K153624, presenting a new design of Morse taper implant-to-abutment interface trade named GM line.

The GM line comprises a range of endosseous dental implants as well as conventional and CAD/CAM abutments described as follows:

The GM Line dental implants are threaded, self-tapping, root form with a Morse taper implantto-abutment interface with an internal hexagonal index exclusive to the GM line. They are made of titanium grade 4 conforming to ASTM F67. They are available in two types of surface treatment:

NeoPoros: rough surface created using an abrasive particle jet concept with controlled grain oxides, followed by acid etching creating uniform cavities in the implant surface.

Acqua: hydrophilic surface created from Neoporos rough surface that undergoes additional processing that renders hydrophilic surface.

GM Titamax implants

The GM Titamax implants have cylindrical shape with double threads of pyramidal profile, rounded apex and are available in diameters of 3.5, 3.75 and 4.0 mm with lengths of 7, 8, 9, 11, 13, 15 and 17 mm, and in 5.0 mm diameter with lengths of 7, 8, 9, 11 and 13 mm. They are recommended for surgical intraoral installation in bone of type I or II.

GM Helix implants

The GM Helix implants have a conical shape, double threads with trapezoidal profile, a rounded apex and are available in diameters of 3.5, 3.75, 4.0, 4.3 and 5.0 mm with lengths of 8, 10, 11.5, 13, 16 and 18 mm. They are recommended for surgical intraoral installation in bones types III or IV, or in bone of type I and II when using conical drills.

GM Drive implants

The GM Drive implants have conical shape with double and progressive threads, cutting chambers in the counterclockwise direction, blade-shaped apical thread, rounded apex and are available in diameters of 3.5, 4.3 and 5.0 mm with lengths of 8, 10, 11.5, 13, 16 and 18 mm. They are recommended for surgical intraoral installation in bone of type III or IV.

The GM Line dental abutments are made of titanium alloy conforming to ASTM F136 and have a machined surface. The abutments are intended to be placed directly onto implants and are recommended according to the available interocclusal space, gingival height, and threedimensional position of the implant. They can be used in immediate or conventional rehabilitation procedures on the maxilla or mandible.

GM Cover Screws

The GM Cover Screws are devices for temporary use during the implant healing phase. They are available in two different heights: at the level of the platform (for use on implants placed at the

5

bone level) and with a gingival height of 2 mm (for use on implants placed up to 2 mm infraosseous). The GM Cover Screws are indicated for use during the osseointegration phase, on Neodent implants to be rehabilitated using the late loading technique. Cover Screws should remain intramucosal, impeding tissue grown over the platform of the implant. Cover Screws are placed out of occlusion.

GM Healings

The GM Healing Abutments are devices for temporary use. They are available in diameters of 3.3 and 4.5 mm and the following gingival heights: 0.8, 1.5, 2.5, 3.5, 4.5, 5.5 mm. They are indicated for maintenance of the soft tissue during the osseointegration phase of Neodent implant to be rehabilitated using the late loading technique. They can be used on the insertion of the Implant or re-opening surgery (second surgical phase). Healing Abutments are placed out of occlusion.

GM Micro Abutments / GM Mini Conical Abutment / GM Exact Mini Conical Abutment

They are intermediary prosthetic components to be installed onto GM implants to support the final prosthesis. They are provided in a rotational shape for the coupling with the prosthesis and in different gingival heights to match the variations in mucosal thickness. The GM Exact Mini Conical abutment is provided angled. They are indicated for screw-retained multiple-unit prostheses onto implants. The GM Micro Abutment, when used with the anti-rotational coping, is also indicated for single-tooth prosthesis.

GM Exact Abutments

GM Exact abutments are intermediary prosthetic components to be installed onto GM implants to support the final prosthesis. They are provided in an anti-rotational shape for the coupling with the prosthesis and are available in 3.5 and 4.8 mm of diameter and the following gingival heights: 0.8, 1.5, 2.5, 3.5, 4.5, 5.5 mm. They are indicated for screw-retained single-tooth prostheses onto implants.

GM Exact Click Universal Abutments (straight and angled)

GM Exact Click Universal abutments are intermediary prosthetic components to be installed onto GM implants to support the final prosthesis. They provided in an anti-rotational shape for the coupling with the prosthesis and in various angulation, prosthetic and gingival heights to match the variation in mucosal thickness. They are indicated for cemented-retained single-tooth prostheses onto implants.

GM Exact Titanium Base abutments

The Titanium Bases are intermediary prosthetic components to be installed onto GM implants to support the final prosthesis; the Titanium Base two-piece abutments used as a base when fabricating a CAD/CAM customized restoration. They are provided in an anti-rotational shape for the coupling with the prosthesis and are available in diameters of 3.5 and 4.5 mm and the following gingival heights: 0.8, 1.5, 2.5, 3.5, 4.5, 5.5 mm. The planning and milling of the customized superstructures must be made using the validated Dental Wings Operating System (DWOS) or 3Shape software. All digitally designed copings and/or crowns for use with the Titanium Bases are intended to be manufactured at a validated milling center. The limits for customization are stated in product IFU. The superstructure produced through CAD/CAM System will compose the second part of the two-piece abutment; the assembly becomes a

6

finished medical device after cementation on Titanium Base. They are indicated cementedretained single-tooth prostheses onto implants.

GM Pro PEEK Abutment

GM Pro PEEK abutments are temporary intermediary prosthetic components to be installed onto the Implants to support the provisional prosthesis up to 6 months. They are composed of a customizable cylindrical body made of PEEK and a non-customizable base made of titanium alloy for an anti-rotational implant connection to GM implants. They are available in 4.5 and 6.0 mm of diameter and the following gingival heights: 0.8, 1.5, 2.5, 3.5, 4.5, 5.5 mm. Pro PEEK Abutments can be used before the installation of the final prosthesis to maintain, stabilize and shape the soft tissue (gum) during the healing phase. Pro PEEK Abutment must not be placed in occlusion when assembled with small diameter implants (≤3.75 mm).

Protection Cylinders

The Protection Cylinders are prosthetic components with a tapered shape intended to be placed on abutments to protect them during the fabrication of the prosthesis and/or healing of the peri-implant tissues. They are available in models for attachment to abutments, mini conical abutments or micro abutments.

Coping Screws

The Coping Screws are prosthetic devices intended for coping fixation on the corresponding GM (screw-retained) abutment. They are available in two different models: one for fitting in GM Exact Abutments and another for fitting in GM Mini and Micro Abutments.

5.2 Indications for Use

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 Abutment System are 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.

7

5.3 Technological Characteristics

The subject and the predicate devices have a range of dental implants and abutments with the same indication of providing solutions for teeth replacement, restoring chewing function.

The subject and predicate devices are based on the following same technological elements:

-Root-form implants intended to replace natural tooth root;
-Endosseous dental abutments to provide support for temporary or permanent restorations;
-Possibility of use in single or two-stage procedures, for single or multiple-unit restorations;
-Implants and conventional and CAD/CAM abutments made of the same material;
-Same sterilization methods and packaging for implants, conventional and CAD/CAM abutments.

The following technological differences exist between the subject and predicate devices:

A new design of Morse taper implant-to-abutment interface is presented; -
-A new design of implant thread was developed to fit in all types of bone quality;
-The subject temporary abutment is provided sterile by EO exposition whereas its predicate device is provided non-sterile for end-user sterilization.

In the end of this Section, a comparison between the features of subject device and its predicate devices is shown in a tabular format. The assessment of the differences is also included.

5.4 Performance data

The following performance data supports the substantial equivalence determination:

Biocompatibility testing

The implants are made of unalloyed titanium, Grade 4, conforming to ASTM F67 Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700). The conventional and CAD/CAM abutments are made of titanium ASTM F136 Standard Specification alloy conforming conforming to for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). The types of titanium are the same to that used for fabrication of the predicate devices cleared under K101945, K150182 and K153624. The subject devices undergo to the same manufacturing processes to the cited predicate devices.

The temporary abutments are made of PEEK. A chemical characterization of this material has been performed to identify leachable inorganic substances and extractable organic substances. Additionally, cytotoxicity analysis also has been performed.

The superstructures for titanium bases are made of zirconia, IPS e.max, Co-Cr and Lava Plus. Zirconia is conforming to ISO 13356 - Implants for surgery - Ceramic materials based on yttriastabilized tetragonal zirconia (Y-TZP), IPS e.max CAD (lithium disilicate) is conforming to ISO

JJGC Indústria e Comércio de Materiais Dentários S.A.

8

6872 - Dentistry - Ceramic Materials and Co-Cr is conforming to ISO 22674 - Dentistry - Metallic materials for fixed and removable restorations and appliances. These raw materials are the same already cleared for the reference predicate devices under K153624. Lava Plus is an yttrium stabilized zirconium oxide (Y-TZP) and complies with the requirements of ISO 6872 Dentistry -Ceramic Materials. Cytotoxicity testing was performed for this raw material and showed no proliferation inhibition. Also, Lava Plus has been cleared by FDA per K072055 for manufacturing of dental restorations through CAD/CAM technique.

Mechanical testing

The strength of the system is demonstrated through fatigue testing performed according to ISO 14801 - Dentistry - Implants - Dynamic fatique test for endosseous dental implants and FDA document Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments. The tested subject devices exhibit a level of performance equivalent to that reviewed for the predicate devices.

Sterilization validation

The subject implants are sterilized by Co60 gamma irradiation at a nominal dose of 25 kGy (2.5 Mrad). Sterilization has been validated by the VDmax® method, according to 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 and ISO 11137-2 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose.

The subject abutments are sterilized by exposure to ethylene oxide (EO). Sterilization has been validated by the bioburden method, according to ISO 11135 Sterilization of health care products - Ethylene oxide - Requirements for the development, validation, and routine control of a sterilization process for medical devices. EO sterilization residuals have been verified to be less than the maximum allowable limits as defined in ISO 10993-7 Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals.

The subject CAD/CAM superstructures are sterilized by moist heat (steam). The recommended sterilization has been validated according to ISO 17665-1 Sterilization of health care products – Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices, and ISO/TS 17665-2 Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1.

All methods achieve a Sterility Assurance Level (SAL) of 10 °.

The sterilization methods presented for the subject devices have been previously reviewed under K101945, K150182 and K153624.

9

Shelf Life Testing

Shelf life testing for the Neodent Implant System was performed for both methods of sterilization, gamma irradiation and ethylene oxide exposure. Shelf life was determined through both accelerated and real time aging protocols according to ASTM F1980 Standard Guide for Accelerated Aging of Sterile Barrier System for Medical Devices.

JJGC Indústria e Comércio de Materiais Dentários S.A.

10

	SUBJECT DEVICES	PRIMARY PREDICATE		REFERENCE PREDICATE DEVICES
	Neodent Implant System –
GM Line	Neodent Implant System
(K101945)	Neodent Implant System
(K150182)	Neodent Implant System
(K153624)	Straumann RC Temp.
Abutment (K093027)	EQUIVALENCE
DISCUSSION
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.	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.	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.
All digitally designed
copings and/or crowns
for use with the Neodent
Titanium Base Abutment
System are intended to
be sent to Straumann for
manufacture at a
validated milling center.	The Straumann RC
Temporary Abutments
are indicated for use in
Straumann RC Bone
Level Implants for
temporary restorations
of single crowns and
bridges for up to six
months	Equivalent
Indications for Use for
GM implants and
conventional abutments:
The indications for use of
the subject devices is
included into the
indications of the
primary predicate
devices.
Indications for Use for
GM Titanium Base
abutments:
The indication for use is
identical to the predicate
K153624.
Indications for Use for
GM Pro Peek Abutments
Both the indications of
subject and predicate
device (K093027) have
the same intention to
provide support to
temporary restorations.
	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 Abutment System are
intended to be sent to Straumann for
manufacture at a validated milling
center.
	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
	SUBJECT DEVICES	PRIMARY PREDICATE	REFERENCE PREDICATE DEVICES
	Neodent Implant System –
GM Line	Neodent Implant System
(K101945)	Neodent Implant System
(K150182)	Neodent Implant System
(K153624)	Straumann RC Temp.
Abutment (K093027)	EQUIVALENCE
DISCUSSION
Diameter(s)	Implants:
3.5 to 5.0 mm
Conventional abutments:
3.3 to 4.8 mm
CAD/CAM abutments:
3.5 and 4.5 mm
Temporary abutments:
4.5 and 6 mm	Implants:
3.5 to 5.0 mm
Conventional abutments:
3.5 to 4.5 mm	Implants:
3.5 to 5.0 mm	CAD/CAM abutments:
3.5 and 4.5 mm	Temporary abutments:
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.
Implants length	8 to 18 mm	8 to 19 mm	18 mm	NA	NA	Equivalent
Subject implant lengths
are within the range of
the predicate devices.
Implants types
of threads	Titamax
Helix
Drive	Titamax
Alvim	Drive	NA	NA	Equivalent
Titamax model remains
the same to that
presented in K101945.
Drive model presents
changes when compared
to K150182, however the
changes do not affect
dynamic fatigue
performance. Helix
model is new, however
tests confirm that they
have equivalent
performances.
Gingival
Heights
(of the
abutments
subject to
masticatory
load)	0.8 to 5.5 mm	0.8 to 6.5 mm	NA	0.8 4.5 mm	Unknown	Equivalent
Subject device heights
are included in the range
of the predicate device
heights and do not
represent a worst case in
terms of performance.
	SUBJECT DEVICES	PRIMARY PREDICATE	REFERENCE PREDICATE DEVICES
	Neodent Implant System –	Neodent Implant System	Neodent Implant System	Neodent Implant System	Straumann RC Temp. Abutment (K093027)	EQUIVALENCE
	GM Line	(K101945)	(K150182)	(K153624)		DISCUSSION
Material	Implants:	Implants:	Implants:	CAD/CAM abutments:	Temporary abutments:	Equivalent
	Titanium grade 4	Titanium grade 4	Titanium grade 4	Titanium alloy Ti-6Al-4V ELI	Titanium alloy (Ti-6Al- 7Nb, TAN)
PEEK
(polyetheretherketone)	The subject and the
predicate devices are
made of the same type
of raw material; the
adequacy of the systems
have been demonstrated
via dynamic fatigue tests
and biocompatibility
assessment.
	Conventional abutments:	Conventional abutments:
	Titanium alloy Ti-6Al-4V ELI	Titanium alloy Ti-6Al-4V
ELI
	CAD/CAM abutments:
	Titanium alloy Ti-6Al-4V ELI
	Temporary abutments:
	Titanium alloy Ti-6Al-4V ELI
PEEK
Implant surface	Neoporos
Acqua	Neoporos	Neoporos
Acqua	NA	NA	Identical

Implant-to-
Abutment
Connection	GM interface; 16° Morse taper
with anti-rotational features.	CM interface; 11.5°
Morse taper with anti-
rotational features.	CM interface; 11.5°
Morse taper with anti-
rotational features.	CM interface; 11.5°
Morse taper with anti-
rotational features.	Morse taper interface
with anti-rotational
features	Equivalent
They are all Morse taper
style connections and
their performances were
assessed by dynamic
fatigue testing.
Compatibility	GM abutments are only
compatible with GM implants	CM (Morse taper) lines
of Neodent Implant
System.	CM (Morse taper)
abutments of Neodent
Implant System.	CM (Morse taper)
implants of Neodent
Implant System.	Straumann implants	Equivalent
The Morse taper
implant-to-abutment
interfaces of Neodent
and Straumann devices
are not interchangeable.
Their performances are
assessed respecting the
fixtures compatibility.
	SUBJECT DEVICES	PRIMARY PREDICATE	REFERENCE PREDICATE DEVICES
	Neodent Implant System -
GM Line	Neodent Implant System
(K101945)	Neodent Implant System
(K150182)	Neodent Implant System
(K153624)	Straumann RC Temp.
Abutment (K093027)	EQUIVALENCE
DISCUSSION
Sterility	Implants:
Delivered sterile via gamma
irradiation.
Conventional abutments:
Delivered sterile by EO
exposure.
CAD/CAM abutments:
Delivered sterile by EO
exposure. To be sterilized by
user after superstructure
cementation, before placed in
patient mouth (moist steam
sterilization).
Temporary abutments:
Delivered sterile by EO
exposure.	Implants:
Delivered sterile via
gamma irradiation.
Conventional abutments:
Delivered sterile by EO
exposure.	Implants:
Delivered sterile via
gamma irradiation.	CAD/CAM abutments:
Delivered sterile by EO
exposure. To be
sterilized by user after
superstructure
cementation, before
placed in patient mouth
(moist steam
sterilization).	Temporary abutments:
Delivered non-sterile; to
be sterilized by user
(moist steam
sterilization).	Equivalent
The sterilization methods
remain the same
amongst the different
Neodent Implant
Systems and, although
the temporary
abutments differs
regarding sterilization,
the Neodent temporary
abutment is
recommended to be
customized chairside and
thus does not need to be
sterilized again before
using.
CAD/CAM
Restoration
Angulation	Up to 30°	NA	NA	Up to 30°	NA	Identical
CAD/CAM
Material of
superstructure	Zirconia
IPS e-max CAD
Co-Cr
Lava Plus	NA	NA	Zirconia
IPS e-max CAD
Co-Cr	NA	Equivalent
The suitability of the
additional raw material is
proven trough
biocompatibility and
performance tests.
CAD/CAM
System	DWOS or 3Shape	NA	NA	DWOS or 3Shape	NA	Identical

Table 1: General comparison between the subject and predicate devices.

11

12

13

14

The following additional tables compare abutments intended to support conventional final restorations.

| | | GM Subject Abutments | Neodent Implant System
(K101945) | EQUIVALENCE DISCUSSION |
|-------------------------------------------------------------------------------------------------------|----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| G
M
E
×
A
C
T
A
B
U
T
M
E
N
T
S | 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 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 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. | Equivalent
The indications for use of the subject
devices is included into the
indications of the primary predicate
devices. |
| | Principle of
operation | To support final restorations when
placed on implants. | To support final restorations when
placed on implants. | Identical |
| | Implant-to-
Abutment
Connection | GM interface. | CM interface | Equivalent
Both are tapered connections. The
performance of the new GM
interface has been assessed by
dynamic fatigue testing. |
| | Implant-
abutment
anti-rotational
feature | With ("Exact") | Without | Equivalent
The anti-rotational feature is
presented in other abutments of
K101945. |
| | Gingival Height | 0.8 to 5.5 mm | 0.8 to 6.5 mm | Equivalent
Subject device heights are included
in the range of the predicate device
heights. |
| | Angulation | Straight | Straight | Identical |
| | Material | Titanium alloy Ti-6Al-4V ELI | Titanium alloy Ti-6Al-4V ELI | Identical |
| | Surface | Machined | Machined | Identical |
| | Compatibility | GM implants | CM implants of Neodent Implant
System. | Equivalent
The Neodent lines are not
interchangeable. Their performances
are assessed respecting the fixtures
compatibility. |
| | Sterility | Delivered sterile by EO exposure. | Delivered sterile by EO exposure. | Identical |
| | | GM Subject Abutments | Neodent Implant System
(K101945) | EQUIVALENCE DISCUSSION |
| G
M
M
I
N
I
C
A
L

A
B
U
T
M
E
N
T
S | 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 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 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. | Equivalent
The indications for use of the subject
devices is included into the
indications of the primary predicate
devices. |
| | Principle of
operation | To support final restorations when
placed on implants. | To support final restorations when
placed on implants. | Identical |
| | Implant-to-
Abutment
Connection | GM interface. | CM interface | Equivalent
Both are tapered connections. The
performance of the new GM
interface has been assessed by
dynamic fatigue testing. |
| | Implant-
abutment
anti-rotational
feature | Straight: without
Angled: with ("Exact") | Straight: without
Angled: with ("Exact") and without | Identical |
| | Gingival Height | Straight: 0.8 to 5.5 mm
Angled: 1.5 to 3.5 mm | Straight: 0.8 to 6.5 mm
Angled: 1.5 to 3.5 mm | Equivalent
Subject device heights are included
in the range of the predicate device
heights. |
| | Angulation | Straight, 17° and 30° | Straight, 17° and 30° | Identical |
| | Material | Titanium alloy Ti-6Al-4V ELI | Titanium alloy Ti-6Al-4V ELI | Identical |
| | Surface | Machined | Machined | Identical |
| | Compatibility | GM implants | CM implants of Neodent Implant
System. | Equivalent
The Neodent lines are not
interchangeable. Their performances
are assessed respecting the fixtures
compatibility. |
| | Sterility | Delivered sterile by EO exposure. | Delivered sterile by EO exposure. | Identical |
| | | GM Subject Abutments | Neodent Implant System
(K101945) | EQUIVALENCE DISCUSSION |
| G
M
M
C
R
O
A
B
U
T
M
E
N
T
S | 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 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 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. | Equivalent
The indications for use of the subject
devices is included into the
indications of the primary predicate
devices. |
| | Principle of
operation | To support final restorations when
placed on implants. | To support final restorations when
placed on implants. | Identical |
| | Implant-to-
Abutment
Connection | GM interface. | CM interface | Equivalent
Both are tapered connections. The
performance of the new GM
interface has been assessed by
dynamic fatigue testing. |
| | Implant-
abutment
anti-rotational
feature | Without | Without | Identical |
| | Gingival Height | 0.8 to 5.5 mm | 1.5 to 3.5 mm | Equivalent
The different gingival heights for
straight abutments do not introduce
a new worst case for fatigue
performance. |
| | Angulation | Straight | Straight | Identical |
| | Material | Titanium alloy Ti-6Al-4V ELI | Titanium alloy Ti-6Al-4V ELI | Identical |
| | Surface | Machined | Machined | Identical |
| | Compatibility | GM implants | CM implants of Neodent Implant
System. | Equivalent
The Neodent lines are not
interchangeable. Their performances
are assessed respecting the fixtures
compatibility. |
| | Sterility | Delivered sterile by EO exposure. | Delivered sterile by EO exposure. | Identical |
| | | GM Subject Abutments | Neodent Implant System
(K101945) | EQUIVALENCE DISCUSSION |
| G
M
E
X
A
C
T
C
L
I
C
K
U
N
I
V
E
R
S
A
L | 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 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 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. | Equivalent
The indications for use of the subject
devices is included into the
indications of the primary predicate
devices. |
| | Principle of
operation | To support final restorations when
placed on implants. | To support final restorations when
placed on implants. | Identical |
| | Implant-to-
Abutment
Connection | GM interface. | CM interface | Equivalent
Both are tapered connections. The
performance of the new GM
interface has been assessed by
dynamic fatigue testing. |
| | Implant-
abutment
anti-rotational
feature | Straight: with ("Exact")
Angled: with ("Exact") | Straight: with ("Exact") and without
Angled: with ("Exact") and without | Identical |
| | Gingival Height | Straight: 0.8 to 5.5 mm
Angled: 1.5 to 3.5 mm | Straight: 0.8 to 6.5 mm
Angled: 1.5 to 3.5 mm | Equivalent
Subject device heights are included
in the range of the predicate device
heights. |
| A
B
U | Angulation | Straight, 17° and 30° | Straight, 17° and 30° | Identical |
| T
M
E
N
T
S | Material | Titanium alloy Ti-6Al-4V ELI | Titanium alloy Ti-6Al-4V ELI | Identical |
| | Surface | Machined | Machined | Identical |
| | Compatibility | GM implants | CM implants of Neodent Implant
System. | Equivalent
The Neodent lines are not
interchangeable. Their performances
are assessed respecting the fixtures
compatibility. |
| | Sterility | Delivered sterile by EO exposure. | Delivered sterile by EO exposure. | Identical |

15

16

17

18

The following additional table compare abutments for short-term use intended to be used
during the healing phase.

		GM Subject Abutments	Straumann Healing Abutments, Healing Caps and Closure Screws (K130808)	EQUIVALENCE DISCUSSION
HEALINGS/
COVERS
SCREWS/
PROTECTION
CYLINDERS	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 procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.	Healing caps, closure screws and healing abutments are intended for use with the -Straumann® Dental Implant System (SDIS) to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process. Customizable healing abutments made of PEEK are used for up to six months.	Equivalent
Both subject and predicate devices are indicated to restore missing teeth by using dental implant systems.
	Principle of operation	Conditioning the soft tissues and closing the implant/abutment interface during healing phase.	Conditioning the soft tissues and closing the implant interface during healing phase.	Equivalent
Protection cylinders are not part of the predicate device scope, however they have the same intention of use.
	Implant-to-Abutment Connection	GM interface.	NC Straumann interface	Equivalent
The different interfaces have no impact in the performance of the implantable system, since these devices are not placed under occlusion.
	Implant-abutment anti-rotational feature	NA	NA	NA
	Gingival Height	0,8 to 5,5 mm	Unknown	The different gingival heights have no impact in the performance of the implantable system, since these devices are not placed under occlusion.
	Angulation	Straight	Straight	Identical
	Material	Titanium alloy Ti-6Al-4V ELI	Titanium grade 4	Equivalent
Both are biocompatible materials and the different types of titanium have no impact in the performance of the implantable system, since these devices are not placed under occlusion.
	Surface	Machined and anodized	Machined and anodized	Identical
	Compatibility	GM implants	NC Straumann implants	Equivalent
The lines are not interchangeable. Their performances are assessed respecting the fixtures compatibility.
	GM Subject Abutments	Straumann Healing Abutments,
Healing Caps and Closure Screws
(K130808)	EQUIVALENCE DISCUSSION
Sterility	Delivered sterile by EO exposure.	Delivered sterile by gamma radiation.	Equivalent
Both sterilization methods assure a
SAL of $10^{-6}$ .

19

K163194

JJGC Indústria e Comércio de Materiais Dentários S.A.

20

| | GM Subject Abutments | Neodent Implant System
(K101945) | EQUIVALENCE DISCUSSION | |
|----------------------------|----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| S
C
R
E
W
S | 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 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 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. | Equivalent
The indications for use of the subject
devices is within the indications for use
cleared for the predicate devices. |
| | Principle of
operation | The screws are used to fix components of a
dental implant system. | The screws are used to fix components of a
dental implant system. | Identical |
| | Implant-to-
Abutment
Connection | GM interface | CM interface | Equivalent
Different interfaces have their
performances assessed via fatigue test. |
| | Implant-
abutment
anti-rotational
feature | NA | NA | NA |
| | Gingival Height | NA | NA | NA |
| | Angulation | Straight | Straight | Identical |
| | Material | Titanium alloy Ti-6Al-4V ELI | Titanium alloy Ti-6Al-4V ELI | Identical |
| | Surface | Machined | Machined | Identical |
| | Compatibility | GM implants | CM implants | Equivalent
The lines are not interchangeable. Their
performances are assessed respecting
the fixtures compatibility. |
| | Sterility | Delivered sterile by EO exposure. | Delivered sterile by EO exposure. | Identical |

21

ર રે Conclusions

The documentation submitted in this premarket notification demonstrates that the subject devices have comparable features and performance and, therefore, are substantially equivalent to the identified predicate devices.

JJGC Indústria e Comércio de Materiais Dentários S.A.