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.

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: cylindrical shape with double threads of pyramidal profile, rounded apex.

GM Helix implants: conical shape, double threads with trapezoidal profile, a rounded apex.

GM Drive implants: conical shape with double and progressive threads, cutting chambers in the counterclockwise direction, blade-shaped apical thread, rounded apex.

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: devices for temporary use during the implant healing phase.

GM Healings: devices for temporary use for maintenance of the soft tissue during the osseointegration phase.

GM Micro Abutments / GM Mini Conical Abutment / GM Exact Mini Conical Abutment: intermediary prosthetic components to be installed onto GM implants to support the final prosthesis.

GM Exact Abutments: intermediary prosthetic components to be installed onto GM implants to support the final prosthesis.

GM Exact Click Universal Abutments (straight and angled): intermediary prosthetic components to be installed onto GM implants to support the final prosthesis.

GM Exact Titanium Base abutments: 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.

GM Pro PEEK Abutment: temporary intermediary prosthetic components to be installed onto the Implants to support the provisional prosthesis up to 6 months.

Protection Cylinders: 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.

Coping Screws: prosthetic devices intended for coping fixation on the corresponding GM (screw-retained) abutment.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA regarding the "Neodent Implant System - GM Line." It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than an independent study proving the device meets specific acceptance criteria in a clinical or performance study context.

Therefore, the information requested in your prompt (Acceptance Criteria, Study Design for proving performance, Sample Sizes, Expert consensus, MRMC studies, etc.) is not present in this document. This document details the comparison of the new device with existing ones based on:

Indications for Use: The new device's indications align with or are subsumed by those of the predicates.
Technological Characteristics: Materials, design features, sterilization methods, and compatibility are compared.
Performance Data (Mechanical Testing and Biocompatibility): This section confirms that the materials meet established standards (ASTM, ISO) and that the device components (implants, abutments) have undergone mechanical fatigue testing according to ISO 14801 and FDA guidance. Biocompatibility has been assessed for the materials used. However, it does not provide specific acceptance criteria or detailed results of these tests, simply stating that the performance is "equivalent" to predicate devices.

Summary of missing information based on your prompt:

Table of acceptance criteria and reported device performance: Not provided in a quantifiable manner for clinical performance. Only mentions "equivalent" mechanical performance based on ISO standards.
Sample sizes for test set and data provenance: No clinical test set involving human subjects is described. Mechanical tests likely involved specific numbers of devices, but these are not disclosed.
Number of experts and qualifications for ground truth: Not applicable as no clinical ground truth assessment is detailed.
Adjudication method for test set: Not applicable.
MRMC comparative effectiveness study: Not conducted or reported. This submission relies on substantial equivalence to existing devices, not a comparative clinical trial with human readers/outcomes.
Standalone performance (algorithm only): Not applicable as this is a physical medical device (dental implant system), not an AI algorithm.
Type of ground truth used: For regulatory purposes, the "ground truth" for this submission is established through comparison to legally marketed predicate devices and adherence to relevant industry standards (ISO, ASTM) and FDA guidance for mechanical and biocompatibility testing. No clinical "ground truth" derived from patient outcomes or expert consensus on images is mentioned regarding the device's function.
Sample size for training set: Not applicable as this is not an AI/ML device.
How ground truth for training set was established: Not applicable.

In conclusion, this document demonstrates regulatory compliance and substantial equivalence through a comparison of device characteristics and a statement of meeting mechanical and biocompatibility standards, rather than presenting a detailed study proving the device meets specific, quantifiable clinical acceptance criteria.

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:

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:

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, LLC60 Minuteman RoadAndover, MA 01810Registration No.: 1222315Owner/Operator No.: 9005052
	on behalf of:JJGC Indústria e Comércio de Materiais Dentários SAAv. Juscelino Kubitschek de Olivera, 3291Curtiba, Parana, BRAZIL 81270-200Registration No.: 3008261720Owner/Operator No.: 10031702
Contact Person	Jennifer M. Jackson, MSDirector, Regulatory Affairs & Quality, Straumann USAE-Mail: jennifer.jackson@straumann.comTelephone (978) 747-2509
Date Prepared	14/Jul/2017
Prepared by	Ana Carolina Martins ViannaRA & Compliance Manager, Institut Straumann AGana.vianna@straumann.com
Product CodeDevice ClassClassification Panel	DZE (21 CFR 872.3640) / NHAIIDental
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 deMateriais Dentários SA
Reference PredicateDevices	K150182 - Neodent Implant System - CM Drive line extension,JJGC Indústria e Comércio de Materiais Dentários SAK153624 - Neodent Implant System, JJGC Indústria e Comércio deMateriais Dentários SAK093027 – Straumann RC Temporary Abutments, InstitutStraumann AGK151455 – 3Shape Abutment Designer Software, 3Shape A/SK130808 - Straumann Healing Abutments, Healing Caps andClosure Screws, Institute Straumann AGK061804 - Zerion Alpha, Zerion Beta, ETKON International, Gmbh

{4}------------------------------------------------

5.1 Device Description

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

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.

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:

Indications for Use for GM Titanium Base abutments:

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:

{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)	EQUIVALENCEDISCUSSION
Indications forUse	for GM implants and conventionalabutments:The Neodent Implant System isintended to be surgically placed inthe bone of the upper or lower jaw toprovide support for prostheticdevices such as artificial teeth, torestore chewing function. It may beused with single-stage or two-stageprocedures, for single or multiple unitrestorations, and may be loadedimmediately when good primarystability is achieved and withappropriate occlusal loading.	The Neodent ImplantSystem is intended to besurgically placed in thebone of the upper orlower jaw to providesupport for prostheticdevices such as artificialteeth, to restore chewingfunction. It may be usedwith single-stage or two-stage procedures, forsingle or multiple unitrestorations, and may beloaded immediatelywhen good primarystability is achieved andwith appropriate occlusalloading. Multiple toothapplications may berigidly splinted.	The Neodent ImplantSystem is intended to besurgically placed in thebone of the upper orlower jaw to providesupport for prostheticdevices such as artificialteeth, to restore chewingfunction. It may be usedwith single-stage or two-stage procedures, forsingle or multiple unitrestorations, and may beloaded immediatelywhen good primarystability is achieved andwith appropriate occlusalloading. Multiple toothapplications may berigidly splinted.	Titanium Base Abutmentis a titanium base placedonto Neodent dentalimplants to providesupport for customizedprosthetic restorations.It is used with a copingand crown, or crownalone, and is indicatedfor cement-retainedsingle or multi-unitrestorations, or screw-retained singlerestorations.All digitally designedcopings and/or crownsfor use with the NeodentTitanium Base AbutmentSystem are intended tobe sent to Straumann formanufacture at avalidated milling center.	The Straumann RCTemporary Abutmentsare indicated for use inStraumann RC BoneLevel Implants fortemporary restorationsof single crowns andbridges for up to sixmonths	EquivalentIndications for Use forGM implants andconventional abutments:The indications for use ofthe subject devices isincluded into theindications of theprimary predicatedevices.Indications for Use forGM Titanium Baseabutments:The indication for use isidentical to the predicateK153624.Indications for Use forGM Pro Peek AbutmentsBoth the indications ofsubject and predicatedevice (K093027) havethe same intention toprovide support totemporary restorations.
	for GM Titanium Base abutments:Titanium Base Abutment is a titaniumbase placed onto Neodent dentalimplants to provide support forcustomized prosthetic restorations. Itis used with a coping and crown, orcrown alone, and is indicated forcement-retained single or multi-unitrestorations, or screw-retained singlerestorations.All digitally designed copings and/orcrowns for use with the NeodentTitanium Base Abutment System areintended to be sent to Straumann formanufacture at a validated millingcenter.
	for GM Pro Peek Abutments:The Pro PEEK Abutments areindicated to be used on Neodentimplants to provide temporarysupport for prosthesis structure forup to 6 months. They can be used inone or two stage procedures and alsoimmediate 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)	EQUIVALENCEDISCUSSION
Diameter(s)	Implants:3.5 to 5.0 mmConventional abutments:3.3 to 4.8 mmCAD/CAM abutments:3.5 and 4.5 mmTemporary abutments:4.5 and 6 mm	Implants:3.5 to 5.0 mmConventional 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	EquivalentSubject device diametersare within the range ofdiameters of thepredicate devices orlarger. Larger diametersdo not represent a worstcase in terms ofperformance.
Implants length	8 to 18 mm	8 to 19 mm	18 mm	NA	NA	EquivalentSubject implant lengthsare within the range ofthe predicate devices.
Implants typesof threads	TitamaxHelixDrive	TitamaxAlvim	Drive	NA	NA	EquivalentTitamax model remainsthe same to thatpresented in K101945.Drive model presentschanges when comparedto K150182, however thechanges do not affectdynamic fatigueperformance. Helixmodel is new, howevertests confirm that theyhave equivalentperformances.
GingivalHeights(of theabutmentssubject tomasticatoryload)	0.8 to 5.5 mm	0.8 to 6.5 mm	NA	0.8 4.5 mm	Unknown	EquivalentSubject device heightsare included in the rangeof the predicate deviceheights and do notrepresent a worst case interms 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 thepredicate devices aremade of the same typeof raw material; theadequacy of the systemshave been demonstratedvia dynamic fatigue testsand biocompatibilityassessment.
	Conventional abutments:	Conventional abutments:
	Titanium alloy Ti-6Al-4V ELI	Titanium alloy Ti-6Al-4VELI
	CAD/CAM abutments:
	Titanium alloy Ti-6Al-4V ELI
	Temporary abutments:
	Titanium alloy Ti-6Al-4V ELIPEEK
Implant surface	NeoporosAcqua	Neoporos	NeoporosAcqua	NA	NA	Identical

Implant-to-AbutmentConnection	GM interface; 16° Morse taperwith 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 interfacewith anti-rotationalfeatures	EquivalentThey are all Morse taperstyle connections andtheir performances wereassessed by dynamicfatigue testing.
Compatibility	GM abutments are onlycompatible with GM implants	CM (Morse taper) linesof Neodent ImplantSystem.	CM (Morse taper)abutments of NeodentImplant System.	CM (Morse taper)implants of NeodentImplant System.	Straumann implants	EquivalentThe Morse taperimplant-to-abutmentinterfaces of Neodentand Straumann devicesare not interchangeable.Their performances areassessed respecting thefixtures 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)	EQUIVALENCEDISCUSSION
Sterility	Implants:Delivered sterile via gammairradiation.Conventional abutments:Delivered sterile by EOexposure.CAD/CAM abutments:Delivered sterile by EOexposure. To be sterilized byuser after superstructurecementation, before placed inpatient mouth (moist steamsterilization).Temporary abutments:Delivered sterile by EOexposure.	Implants:Delivered sterile viagamma irradiation.Conventional abutments:Delivered sterile by EOexposure.	Implants:Delivered sterile viagamma irradiation.	CAD/CAM abutments:Delivered sterile by EOexposure. To besterilized by user aftersuperstructurecementation, beforeplaced in patient mouth(moist steamsterilization).	Temporary abutments:Delivered non-sterile; tobe sterilized by user(moist steamsterilization).	EquivalentThe sterilization methodsremain the sameamongst the differentNeodent ImplantSystems and, althoughthe temporaryabutments differsregarding sterilization,the Neodent temporaryabutment isrecommended to becustomized chairside andthus does not need to besterilized again beforeusing.
CAD/CAMRestorationAngulation	Up to 30°	NA	NA	Up to 30°	NA	Identical
CAD/CAMMaterial ofsuperstructure	ZirconiaIPS e-max CADCo-CrLava Plus	NA	NA	ZirconiaIPS e-max CADCo-Cr	NA	EquivalentThe suitability of theadditional raw material isproven troughbiocompatibility andperformance tests.
CAD/CAMSystem	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
GME×ACTABUTMENTS	Indications forUse	The Neodent Implant System isintended to be surgically placed in thebone of the upper or lower jaw toprovide support for prosthetic devicessuch as artificial teeth, to restorechewing function. It may be used withsingle-stage or two-stage procedures,for single or multiple unit restorations,and may be loaded immediately whengood primary stability is achieved andwith appropriate occlusal loading.	The Neodent Implant System isintended to be surgically placed in thebone of the upper or lower jaw toprovide support for prosthetic devicessuch as artificial teeth, to restorechewing function. It may be used withsingle-stage or two-stage procedures,for single or multiple unit restorations,and may be loaded immediately whengood primary stability is achieved andwith appropriate occlusal loading.Multiple tooth applications may berigidly splinted.	EquivalentThe indications for use of the subjectdevices is included into theindications of the primary predicatedevices.
	Principle ofoperation	To support final restorations whenplaced on implants.	To support final restorations whenplaced on implants.	Identical
	Implant-to-AbutmentConnection	GM interface.	CM interface	EquivalentBoth are tapered connections. Theperformance of the new GMinterface has been assessed bydynamic fatigue testing.
	Implant-abutmentanti-rotationalfeature	With ("Exact")	Without	EquivalentThe anti-rotational feature ispresented in other abutments ofK101945.
	Gingival Height	0.8 to 5.5 mm	0.8 to 6.5 mm	EquivalentSubject device heights are includedin the range of the predicate deviceheights.
	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 ImplantSystem.	EquivalentThe Neodent lines are notinterchangeable. Their performancesare assessed respecting the fixturescompatibility.
	Sterility	Delivered sterile by EO exposure.	Delivered sterile by EO exposure.	Identical
		GM Subject Abutments	Neodent Implant System(K101945)	EQUIVALENCE DISCUSSION
GMMINICALABUTMENTS	Indications forUse	The Neodent Implant System isintended to be surgically placed in thebone of the upper or lower jaw toprovide support for prosthetic devicessuch as artificial teeth, to restorechewing function. It may be used withsingle-stage or two-stage procedures,for single or multiple unit restorations,and may be loaded immediately whengood primary stability is achieved andwith appropriate occlusal loading.	The Neodent Implant System isintended to be surgically placed in thebone of the upper or lower jaw toprovide support for prosthetic devicessuch as artificial teeth, to restorechewing function. It may be used withsingle-stage or two-stage procedures,for single or multiple unit restorations,and may be loaded immediately whengood primary stability is achieved andwith appropriate occlusal loading.Multiple tooth applications may berigidly splinted.	EquivalentThe indications for use of the subjectdevices is included into theindications of the primary predicatedevices.
	Principle ofoperation	To support final restorations whenplaced on implants.	To support final restorations whenplaced on implants.	Identical
	Implant-to-AbutmentConnection	GM interface.	CM interface	EquivalentBoth are tapered connections. Theperformance of the new GMinterface has been assessed bydynamic fatigue testing.
	Implant-abutmentanti-rotationalfeature	Straight: withoutAngled: with ("Exact")	Straight: withoutAngled: with ("Exact") and without	Identical
	Gingival Height	Straight: 0.8 to 5.5 mmAngled: 1.5 to 3.5 mm	Straight: 0.8 to 6.5 mmAngled: 1.5 to 3.5 mm	EquivalentSubject device heights are includedin the range of the predicate deviceheights.
	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 ImplantSystem.	EquivalentThe Neodent lines are notinterchangeable. Their performancesare assessed respecting the fixturescompatibility.
	Sterility	Delivered sterile by EO exposure.	Delivered sterile by EO exposure.	Identical
		GM Subject Abutments	Neodent Implant System(K101945)	EQUIVALENCE DISCUSSION
GMMCROABUTMENTS	Indications forUse	The Neodent Implant System isintended to be surgically placed in thebone of the upper or lower jaw toprovide support for prosthetic devicessuch as artificial teeth, to restorechewing function. It may be used withsingle-stage or two-stage procedures,for single or multiple unit restorations,and may be loaded immediately whengood primary stability is achieved andwith appropriate occlusal loading.	The Neodent Implant System isintended to be surgically placed in thebone of the upper or lower jaw toprovide support for prosthetic devicessuch as artificial teeth, to restorechewing function. It may be used withsingle-stage or two-stage procedures,for single or multiple unit restorations,and may be loaded immediately whengood primary stability is achieved andwith appropriate occlusal loading.Multiple tooth applications may berigidly splinted.	EquivalentThe indications for use of the subjectdevices is included into theindications of the primary predicatedevices.
	Principle ofoperation	To support final restorations whenplaced on implants.	To support final restorations whenplaced on implants.	Identical
	Implant-to-AbutmentConnection	GM interface.	CM interface	EquivalentBoth are tapered connections. Theperformance of the new GMinterface has been assessed bydynamic fatigue testing.
	Implant-abutmentanti-rotationalfeature	Without	Without	Identical
	Gingival Height	0.8 to 5.5 mm	1.5 to 3.5 mm	EquivalentThe different gingival heights forstraight abutments do not introducea new worst case for fatigueperformance.
	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 ImplantSystem.	EquivalentThe Neodent lines are notinterchangeable. Their performancesare assessed respecting the fixturescompatibility.
	Sterility	Delivered sterile by EO exposure.	Delivered sterile by EO exposure.	Identical
		GM Subject Abutments	Neodent Implant System(K101945)	EQUIVALENCE DISCUSSION
GMEXACTCLICKUNIVERSAL	Indications forUse	The Neodent Implant System isintended to be surgically placed in thebone of the upper or lower jaw toprovide support for prosthetic devicessuch as artificial teeth, to restorechewing function. It may be used withsingle-stage or two-stage procedures,for single or multiple unit restorations,and may be loaded immediately whengood primary stability is achieved andwith appropriate occlusal loading.	The Neodent Implant System isintended to be surgically placed in thebone of the upper or lower jaw toprovide support for prosthetic devicessuch as artificial teeth, to restorechewing function. It may be used withsingle-stage or two-stage procedures,for single or multiple unit restorations,and may be loaded immediately whengood primary stability is achieved andwith appropriate occlusal loading.Multiple tooth applications may berigidly splinted.	EquivalentThe indications for use of the subjectdevices is included into theindications of the primary predicatedevices.
	Principle ofoperation	To support final restorations whenplaced on implants.	To support final restorations whenplaced on implants.	Identical
	Implant-to-AbutmentConnection	GM interface.	CM interface	EquivalentBoth are tapered connections. Theperformance of the new GMinterface has been assessed bydynamic fatigue testing.
	Implant-abutmentanti-rotationalfeature	Straight: with ("Exact")Angled: with ("Exact")	Straight: with ("Exact") and withoutAngled: with ("Exact") and without	Identical
	Gingival Height	Straight: 0.8 to 5.5 mmAngled: 1.5 to 3.5 mm	Straight: 0.8 to 6.5 mmAngled: 1.5 to 3.5 mm	EquivalentSubject device heights are includedin the range of the predicate deviceheights.
ABU	Angulation	Straight, 17° and 30°	Straight, 17° and 30°	Identical
TMENTS	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 ImplantSystem.	EquivalentThe Neodent lines are notinterchangeable. Their performancesare assessed respecting the fixturescompatibility.
	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/COVERSSCREWS/PROTECTIONCYLINDERS	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.	EquivalentBoth 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.	EquivalentProtection 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	EquivalentThe 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	EquivalentBoth 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	EquivalentThe 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.	EquivalentBoth sterilization methods assure aSAL of $10^{-6}$ .

{19}------------------------------------------------

K163194

JJGC Indústria e Comércio de Materiais Dentários S.A.

{20}------------------------------------------------

	GM Subject Abutments	Neodent Implant System(K101945)	EQUIVALENCE DISCUSSION
SCREWS	Indications forUse	The Neodent Implant System isintended to be surgically placed in thebone of the upper or lower jaw toprovide support for prosthetic devicessuch as artificial teeth, to restorechewing function. It may be used withsingle-stage or two-stage procedures,for single or multiple unit restorations,and may be loaded immediately whengood primary stability is achieved andwith appropriate occlusal loading.	The Neodent Implant System isintended to be surgically placed in thebone of the upper or lower jaw toprovide support for prosthetic devicessuch as artificial teeth, to restorechewing function. It may be used withsingle-stage or two-stage procedures,for single or multiple unit restorations,and may be loaded immediately whengood primary stability is achieved andwith appropriate occlusal loading.Multiple tooth applications may berigidly splinted.	EquivalentThe indications for use of the subjectdevices is within the indications for usecleared for the predicate devices.
	Principle ofoperation	The screws are used to fix components of adental implant system.	The screws are used to fix components of adental implant system.	Identical
	Implant-to-AbutmentConnection	GM interface	CM interface	EquivalentDifferent interfaces have theirperformances assessed via fatigue test.
	Implant-abutmentanti-rotationalfeature	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	EquivalentThe lines are not interchangeable. Theirperformances are assessed respectingthe 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.

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.