Neodent Implant System – GM Line

K180536 · Jjgc Industria E Comercio DE Materiais Dentarios S.A. · DZE · Aug 30, 2018 · Dental

Device Facts

• Record ID: K180536
• Device Name: Neodent Implant System – GM Line
• Applicant: Jjgc Industria E Comercio DE Materiais Dentarios S.A.
• Product Code: DZE · Dental
• Decision Date: Aug 30, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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. GM Exact Titanium Block for Medentika Holder is a titanium abutment to be used in fabricating a full custom and placed onto Neodent dental implants to provide support for customized prosthetic restorations. The GM Exact Titanium Block for Medentika Holder abutments are indicated for screw-retained single restorations or cement-retained single or multi-unit restorations. All digitally designed abutments for use with the GM Exact Titanium Block for Medentika Holder are intended to be sent to Straumann for manufacture at a validated milling center. 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 alone, and is indicated for cement-retained single or multi-unit restorations, or screw-retained single restorations. All digitally designed copins for use with the Neodent Titanium Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center. The Titanium Base C for GM Exact abutments is a titanium component that is placed over Neodent implants to provide support for custom prosthetic restorations, such as copins. It is indicated for single-tooth screw-retained restorations. All digitally designed copings and/or crowns for use with the Titanium Base C for GM Exact abutments are to be designed using Sirona inLab software or Sirona CEREC Software and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit.

Device Story

Neodent Implant System - GM Line consists of endosseous dental implants and associated abutments. Implants are surgically placed in jaw bone; provide support for prosthetic restorations. System includes GM Helix implants, customizable healing abutments, and titanium base/block abutments for CAD/CAM fabrication. Components interface with Neodent GM implants via Morse taper connection. Clinicians use CAD/CAM software (DWOS, 3Shape, Sirona inLab/CEREC) to design custom superstructures; manufacturing occurs at validated milling centers. Final assembly involves cementation of custom superstructure onto titanium base/block. Device restores chewing function; benefits patients through customized prosthetic support. Used in dental clinics by dentists/specialists.

Clinical Evidence

No clinical data submitted. Substantial equivalence supported by non-clinical bench testing: sterilization validation (ISO 11137, ISO 11135, ISO 17665), biocompatibility (ISO 10993), sterile barrier shelf life (ASTM F1980, F88, F1929), and mechanical fatigue testing (ISO 14801).

Technological Characteristics

Materials: Unalloyed titanium (ASTM F67), titanium alloy (ASTM F136), PEEK. Design: Threaded root-form implants with internal GM Morse taper (16°) connection. Surface: NeoPoros (grit-blasted/acid-etched) and Acqua (hydrophilic). Connectivity: CAD/CAM workflow for custom abutments via validated milling centers. Sterilization: Validated per ISO standards.

Indications for Use

Indicated for patients requiring dental implants in the upper or lower jaw to support prosthetic devices (artificial teeth) for restoration of chewing function. Applicable for single or multiple unit restorations, single or two-stage procedures, and immediate loading when primary stability is achieved. Specific abutments indicated for screw-retained single or cement-retained single/multi-unit restorations.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Neodent Implant System - GM Line (K163194)

Reference Devices

• Neodent Implant System (K123022)
• Neodent Implant System - Titanium Bases for CEREC (K160964)
• Neodent Implant System (K150367)

Submission Summary (Full Text)

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August 30, 2018

JJGC Indústria e Comércio de Materiais Dentários S.A. % Kevin Thomas Vice President and Director of Regulatory Affairs PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130

Re: K180536

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: August 6, 2018 Received: August 7, 2018

Dear Kevin Thomas:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Andrew I. Steen -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known)

# K180536

Device Name

Neodent Implant System - GM Line

#### Indications for Use (Describe)

Indications for Use for GM Helix 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 attificial 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 Exact Titanium Block for Medentika Holder:

GM Exact Titanium Block for Medentika Holder is a titanium abutment to be used in fabricating a full custom and placed onto Neodent dental implants to provide support for customized prosthetic restorations. The GM Exact Titanium Block for Medentika Holder abutments are indicated for screw-retained single restorations or cement-retained single or multi-unit restorations. All digitally designed abutments for use with the GM Exact Titanium Block for Medentika Holder are intended to be sent to Straumann for manufacture at a validated milling center.

Indications for Use for GM Exact 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 alone, and is indicated for cement-retained single or multi-unit restorations, or screw-retained single restorations. All digitally designed copins 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 Titanium Base C for GM Exact abutments:

The Titanium Base C for GM Exact abutments is a titanium component that is placed over Neodent implants to provide support for custom prosthetic restorations, such as copins. It is indicated for single-tooth screw-retained restorations. All digitally designed copings and/or crowns for use with the Titanium Base C for GM Exact abutments are to be designed using Sirona inLab software or Sirona CEREC Software and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit.

Type of Use (Select one or both, as applicable)

|X | Prescription Use (Part 21 CFR 801 Subpart D)

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### 510(k) Summary K180536

# Neodent Implant System - GM Line JJGC Indústria e Comércio de Materiais Dentários SA

August 29, 2018

#### ADMINISTRATIVE INFORMATION

| Manufacturer Name | JJGC Indústria e Comércio de Materiais Dentários SA<br>Av. Juscelino Kubitschek de Oliveira, 3291 - CIC<br>Curitiba, Paraná, 81270-200, Brazil | | | |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|--|--|
| | Telephone: | [phone] | | |
| | Fax: | [phone] | | |
| Official Contact | Julianne de Oliveira Capucho Lechechem<br>Regulatory Affairs Manager | | | |
| Representative/Consultant | Kevin A. Thomas, PhD | | | |
| | Floyd G. Larson, MS, MBA | | | |
| | PaxMed International, LLC | | | |
| | 12264 El Camino Real, Suite 400 | | | |
| | San Diego, CA 92130 | | | |
| | Telephone: | [phone] | | |
| | Fax: | [phone] | | |
| | Email: | [e-mail] | | |
| | | [e-mail] | | |

#### DEVICE NAME AND CLASSIFICATION

| Trade/Proprietary Name | Neodent Implant System - GM Line |
|---------------------------|----------------------------------|
| Common Name | Dental implant and abutment |
| Classification Name | Endosseous dental implant |
| Classification Regulation | 21 CFR 872.3640 |
| | |

Device Class Product Codes Class II DZE, NHA

Classification Panel Dental Products Panel Reviewing Branch Dental Devices Branch

#### PREDICATE DEVICE INFORMATION

The primary predicate device is K163194. The reference devices are K123022, K160964, and K150367.

#### INDICATIONS FOR USE

Indications for Use for GM Helix 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.

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Indications for Use for GM Exact Titanium Block for Medentika Holder:

GM Exact Titanium Block for Medentika Holder is a titanium abutment to be used in fabricating a full custom abutment and placed onto Neodent dental implants to provide support for customized prosthetic restorations. The GM Exact Titanium Block for Medentika Holder abutments are indicated for screw-retained single restorations or cement-retained single or multi-unit restorations. All digitally designed abutments for use with the GM Exact Titanium Block for Medentika Holder are intended to be sent to Straumann for manufacture at a validated milling center.

Indications for Use for GM Exact 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 Titanium Base C for GM Exact abutments:

The Titanium Base C for GM Exact abutments is a titanium component that is placed over Neodent implants to provide support for custom prosthetic restorations, such as copings or crowns. It is indicated for single-tooth screw-retained restorations.

All digitally designed copings and/or crowns for use with the Titanium Base C for GM Exact abutments are to be designed using Sirona inLab software or Sirona CEREC Software and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit.

#### SUBJECT DEVICE DESCRIPTION

The purpose of this submission is to expand the Neodent Implant System - GM Line components cleared under K163194, which included dental implants with a Morse taper abutment interface (called Grand Morse, or GM), mating abutment screws, and other associated components. This submission includes: GM Helix Implant in diameter (6 mm), overall lengths of 8 mm to 13 mm, and in two endosseous surfaces, grit-blasted and acid etched (NeoPoros) and hydrophilic surface (Acqua); GM Customizable Healing Abutment in two prosthetic diameters (5.5 mm and 7.0 mm), each in multiple gingival heights (ranging from 1.5 mm to 6.5 mm); GM Exact Titanium Block for Medentika Holder titanium blank abutment, in two milling diameters, 11.5 mm and 15.8 mm; GM Exact Titanium Base in one prosthetic diameter (5.5 mm), six gingival heights (from 0.8 mm to 5.5 mm), and two prosthetic post heights (4 mm and 6 mm); and Titanium Base C for GM Exact one prosthetic diameter (4.65 mm), 6 gingival heights (from 0.8 mm to 5.5 mm), and one prosthetic post height (4.7 mm).

The GM Exact Titanium Base and Titanium Base C for GM Exact are intermediary prosthetic components to be installed onto GM implants to support the final prosthesis; the GM Exact Titanium Base and Titanium Base C for GM Exact are two piece abutments used as a base when fabricating a CAD/CAM customized restoration. The GM Exact Titanium Base C for GM Exact are provided in an anti-rotational shape for the coupling with the prosthesis and are available in diameters of 4.65 mm (Titanium Base C for GM Exact) and 5.5 mm (GM Exact Titanium Base), 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 GM Exact Titanium Base and Titanium Base C for GM Exact are intended to be manufactured at a validated milling center. The limits for customization are stated in the GM Exact Titanium Base and Titanium Base C for GM Exact 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 the GM Exact Titanium

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Base or Titanium Base C for GM Exact. The GM Exact Titanium Base is indicated for screw-retained single-unit, or cement-retained single or multi-unit prosthesis attachment onto implants. The Titanium Base C for GM Exact is indicated for cement-retained single-unit prosthesis attachment onto implants.

The subject device abutments components mate exclusively with the GM implants cleared in K163194.

#### PERFORMANCE DATA

Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence included: sterilization validation according to ISO 11137-1, ISO 11137-2. ISO 11135, ISO 10993-7, ISO 17665-1, ISO 17665-2, and ISO 11135 10993-7 (referenced from K163194); bacterial endotoxin according to AAMI/ANSI ST72 (referenced from K163194); sterile barrier shelf life testing (accelerated aging according to ASTM F1980; seal integrity according to ASTM E499/E499M and ASTM F1929; seal strength according to ASTM F88/F88M; and sterility of the package contents according to ISO 11737, all referenced from K163194); biocompatibility (referenced from K163194); engineering analysis; dimensional analysis; and static and dynamic compression-bending to ISO 14801. Clinical data were not submitted in this premarket notification.

#### EQUIVALENCE TO MARKETED DEVICES

IJGC Indústria e Comércio de Materiais Dentários S.A. submits the information in this Premarket Notification to demonstrate that, for the purposes of FDA 's regulation of medical devices, the subject device is substantially equivalent in indications and design principles to the following legally marketed predicate and reference devices:

K163194. Neodent Implant System - GM Line, JJGC Indústria e Comércio de Materiais Dentários S.A .; K 123022, Neodent Implant System, JJGC Indústria e Comércio de Materiais Dentários S.A .; K160964, Neodent Implant System - Titanium Bases for CEREC, JJGC Indústria e Comércio de Materiais Dentários S.A.; and

K150367, Neodent Implant System, JJGC Indústria e Comércio de Materiais Dentários S.A.

A comparison of the Indications for Use statements for the subject device and the predicate and reference devices is provided in the following table.

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# Table of Substantial Equivalence – Indications for Use Statements

| | Subject Device | Primary Predicate Device | Reference Devices | | |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison | K180536 | K163194 | K123022 | K160964 | K150367 |
| | Neodent Implant System - GM Line | Neodent Implant System - GM Line | Neodent Implant System | Neodent Implant System - Titanium<br>Bases for CEREC | Neodent Implant System |
| | JJGC Indústria e Comércio de<br>Materiais Dentários S.A. | JJGC Indústria e Comércio de<br>Materiais Dentários S.A. | JJGC Indústria e Comércio de<br>Materiais Dentários S.A. | JJGC Indústria e Comércio de<br>Materiais Dentários S.A. | JJGC Indústria e Comércio de<br>Materiais Dentários S.A |
| Indications for<br>Use Statement | Indications for Use for GM Helix Implants and<br>conventional abutments:<br>The Neodent Implant System is intended to be<br>surgically placed in the bone of the upper or lower<br>jaw to provide support for prosthetic devices such as<br>artificial teeth, to restore chewing function. It may be<br>used with single-stage or two-stage procedures, for<br>single or multiple unit restorations, and may be<br>loaded immediately when good primary stability is<br>achieved and with appropriate occlusal loading.<br>Indications for Use for GM Exact Titanium Block for<br>Medentika Holder:<br>GM Exact Titanium Block for Medentika Holder is a<br>titanium abutment to be used in fabricating a full<br>custom abutment and placed onto Neodent dental<br>implants to provide support for customized prosthetic<br>restorations. The GM Exact Titanium Block for<br>Medentika Holder abutments are indicated for screw-<br>retained single restorations or cement-retained single<br>or multi-unit restorations. All digitally designed<br>abutments for use with the GM Exact Titanium Block<br>for Medentika Holder are intended to be sent to<br>Straumann for manufacture at a validated milling<br>center.<br>Indications for Use for GM Exact Titanium Base<br>abutments:<br>Titanium Base Abutment is a titanium base placed<br>onto Neodent dental implants to provide support for<br>customized prosthetic restorations. It is used with a<br>coping and crown, or crown alone, and is indicated<br>for cement-retained single or multi-unit restorations.<br>or screw-retained single restorations. All digitally<br>designed copings and/or crowns for use with the<br>Neodent Titanium Base Abutment System are<br>intended to be sent to Straumann for manufacture at<br>validated milling center.<br>Indications for Use for Titanium Base C for GM<br>Exact abutments:<br>The Titanium Base C for GM Exact abutments is a<br>titanium component that is placed over Neodent<br>implants to provide support for custom prosthetic<br>restorations, such as copings or crowns. It is<br>indicated for single-tooth screw-retained restorations.<br>All digitally designed copings and/or crowns for use<br>with the Titanium Base C for GM Exact abutments<br>are to be designed using Sirona inLab software or<br>Sirona CEREC Software and manufactured using a<br>Sirona CEREC or inLab MC X or MC XL milling<br>unit. | Indications for Use for GM implants and<br>conventional abutments:<br>The Neodent Implant System is intended<br>to be surgically placed in the bone of the<br>upper or lower jaw to provide support for<br>prosthetic devices such as artificial teeth,<br>to restore chewing function. It may be<br>used with single-stage or two-stage<br>procedures, for single or multiple unit<br>restorations, and may be loaded<br>immediately when good primary stability<br>is achieved and with appropriate occlusal<br>loading.<br>Indications for Use for GM Titanium Base<br>abutments:<br>Titanium Base Abutment is a titanium<br>base placed onto Neodent dental implants<br>to provide support for customized<br>prosthetic restorations. It is used with a<br>coping and crown, or crown alone, and is<br>indicated for cement-retained single or<br>multi-unit restorations, or screw-retained<br>single restorations. All digitally designed<br>copings and/or crowns for use with the<br>Neodent Titanium Base Abutment System<br>are intended to be sent to Straumann for<br>manufacture at a validated milling center.<br>Indications for Use for GM Pro Peek<br>Abutments:<br>The Pro PEEK Abutments are indicated to<br>be used on Neodent implants to provide<br>temporary support for prosthesis structure<br>for up to 6 months. They can be used in<br>one or two stage procedures and also<br>immediate load when there is good<br>primary stability. | The Neodent Implant System is<br>intended to be surgically placed in the<br>bone of the upper or lower jaw to<br>provide support for prosthetic devices<br>such as artificial teeth, to restore<br>chewing function. It may be used with<br>single-stage or two-stage procedures, for<br>single or multiple unit restorations, and<br>may be loaded immediately when good<br>primary stability is achieved and with<br>appropriate occlusal loading.<br>Titamax WS implant is indicated for a<br>delayed loading protocol.<br>The Facility implant is indicated for<br>replacement of maxillary lateral<br>incisors, mandibular incisors or<br>retention of overdentures. | The Titanium Base for CEREC is a<br>titanium component that is placed over<br>Neodent Implants to provide support for<br>custom prosthetic restorations, such as<br>copings or crowns. It is indicated for<br>single-tooth screw-retained restorations.<br>All digitally designed copings and/or<br>crowns for use with the Neodent Titanium<br>Base for CEREC are to be designed using<br>Sirona inLab software or Sirona CEREC<br>Software and manufactured using a Sirona<br>CEREC or inLab MC X or MC XL<br>milling unit. | Titanium Base Abutment is a titanium<br>base placed onto Neodent dental implants<br>to provide support for customized<br>prosthetic restorations. It is used with a<br>coping and crown, or crown alone, and is<br>indicated for cement-retained single or<br>multi-unit restorations, or screw-retained<br>single restorations.<br>PreFace Abutment is a titanium abutment<br>to be used in fabricating a full custom<br>abutment and placed onto Neodent dental<br>implants to provide support for<br>customized prosthetic restorations.<br>PreFace Abutments are indicated for<br>screw-retained single restorations or<br>cement-retained single or multi-unit<br>restorations. |

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The Indications for Use Statement for the subject device (implants and conventional abutments section) is identical to the corresponding section of the Indications for Use Statement of the primary predicate device K163194. The Indications for Use Statement for the subject device (implants section) is identical to the corresponding section of the Indications for Use Statement of the reference device K123022. The Indications for Use Statement for the subject device (GM Exact Titanium Base abutments section) is identical to the corresponding section of the Indications for Use Statement of K163164 (GM Titanium Base abutments section), except for the names of the devices. The conventional abutments in this submission are the GM Customizable Healing Abutment. The subject device GM Exact Titanium Base abutments and Titanium Base C for GM Exact abutments are not considered conventional abutments. The slight differences in wording among the Indications for Use Statements for the subject device, K163194, and K123022 do not affect the intended use with dental implants for rehabilitation of the edentulous maxilla or mandible.

The Indications for Use Statement for the subject device (GM Exact Titanium Block for Medentika Holder section) is similar to the PreFace section of the Indications for Use Statement of the reference device K150367. The slight differences are the names of the devices (both are to be used with Medentika holder) and, for the subject device statement, the requirement to manufacture at a Straumann milling center. For K160367 the requirement to manufacture at a Straumann milling center was included in the labeling. The slight differences in wording between the Indications for Use Statements for the subject device and the reference device K150367 do not affect the intended use with dental implants for rehabilitation of the edentulous maxilla or mandible.

The Indications for Use Statement for the subject device (Titanium Base C for GM Exact abutments section) is similar to the Indications for Use Statement of the reference device K160964. The slight difference is the names of the devices. The slight differences in wording between the Indications for Use Statements for the subject device and the reference device K160964 do not affect the intended use with dental implants for rehabilitation of the edentulous maxilla or mandible.

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

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510(k) Summary Page 6 of 9

# Table of Substantial Equivalence – Technological Characteristics

| | Subject Device | Primary Predicate Device | Technological Characteristics | Reference Devices | |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| Comparison | K180536 | K163194 | K123022 | K160964 | K150367 |
| | Neodent Implant System - GM Line | Neodent Implant System - GM Line | Neodent Implant System | Neodent Implant System - Titanium<br>Bases for CEREC | Neodent Implant System |
| | JJGC Indústria e Comércio de<br>Materiais Dentários S.A. | JJGC Indústria e Comércio de<br>Materiais Dentários S.A. | JJGC Indústria e Comércio de<br>Materiais Dentários S.A. | JJGC Indústria e Comércio de<br>Materiais Dentários S.A. | JJGC Indústria e Comércio de<br>Materiais Dentários S.A |
| Reason for<br>Predicate | Not applicable | Implant-abutment GM interface;<br>Implant design; Healing Abutment<br>design; Titanium Base designs | Implant design, 6 mm diameter | Titanium Base C design | Titanium Block (milling) design |
| Implants | | | | | |
| Implant Design | Threaded root-form implants, 1 thread design;<br>Internal GM Morse taper connection (16°),<br>with internal hex indexing feature ("Exact") | Threaded root-form implants, 3<br>thread designs;<br>Internal GM Morse taper<br>connection(16°), with internal hex<br>indexing feature ("Exact") | Threaded root-form implants, 3<br>thread designs;<br>Internal CM Morse taper<br>connection(11.5°) | | |
| Implant Diameter | GM Helix: 6.0 mm | GM Helix: 3.5, 3.75, 4.0, 4.3, 5.0<br>mm | Titamax WS implant: 4.0, 5.0, 6.0<br>mm | | |
| Implant Length | GM Helix: 8, 10, 11.5, 13 mm | GM Helix: 8, 10, 11.5, 13, 16, 18<br>mm | Titamax WS implant: 5, 6 mm | | |
| Material | Unalloyed titanium ASTM F67 | Unalloyed titanium ASTM F67 | Titamax WS implant: Unalloyed<br>titanium ASTM F67 | | |
| Endosseous<br>surface | NeoPoros (grit-blasted, acid-etched<br>Acqua (NeoPoros + hydrophilic treatment) | NeoPoros (grit-blasted, acid-etched<br>Acqua (NeoPoros + hydrophilic<br>treatment) | NeoPoros (grit-blasted, acid-etched | | |
| Abutments | | | | | |
| Healing<br>Abutment | GM Customizable Healing Abutment | GM Pro PEEK Abutment | | | |
| Body (prosthetic)<br>diameter | 5.5 mm and 7.0 mm | 4.5 mm and 6.0 mm | | | |
| Gingival height | 5.5 mm Ø: 1.5, 2.5, 3.5, 4.5, 5.5 mm<br>7.0 mm Ø: 2.5, 3.5, 4.5, 5.5, 6.5 mm | 4.5 mm Ø: 0.8, 1.5, 2.5, 3.5, 4.5, 5.5<br>mm<br>6.0 mm Ø: 0.8, 1.5, 2.5, 3.5, 4.5, 5.5<br>mm | | | |
| Material | Titanium alloy ASTM F136 (interface to<br>implant)<br>PEEK (customizable portion) | Titanium alloy ASTM F136<br>(interface to implant)<br>PEEK (customizable portion) | | | |
| Implant interface | Interfaces exclusively to Neodent GM<br>implants | Interfaces exclusively to Neodent<br>GM implants | | | |
| Titanium Block<br>(milling) | GM Exact Titanium Block for Medentika<br>Holder | GM Exact Click Universal Abutment<br>30° | | | PreFace |
| Body (milling)<br>diameter | 11.5 mm and 15.8 mm | n/a | | | 11.5 mm and 15.8 mm |
| Abutment angle | 15.8 mm Ø only: up to 30° | 0°, 17°, 30° | | | 15.8 mm Ø only: up to 30° |
| Prosthesis<br>attachment | Screw-retained single-unit, or<br>Cement-retained single or multi-unit | Cement-retained single-unit | | | Screw-retained single-unit, or<br>Cement-retained single or multi-unit |
| Material | Titanium alloy ASTM F136 | Titanium alloy ASTM F136 | | | Titanium alloy ASTM F136 |
| | | | | | |
| Comparison | Subject Device | Primary Predicate Device | Reference Devices | | |
| | K180536 | K163194 | K123022 | K160964 | K150367 |
| Implant interface | Interfaces exclusively to GM implants | Interfaces exclusively to GM<br>implants | | | Interfaces exclusively to Neodent<br>CM Morse taper implants |
| Titanium Base | GM Exact Titanium Base | GM Exact Titanium Base | | | Titanium Base |
| Body (prosthetic)<br>diameter | 5.5 mm | 3.5 mm and 4.5 mm | | | 3.5 mm and 4.5 mm |
| Abutment angle | Up to 30° | Up to 30° | | | Up to 30° |
| Gingival height | 0.8, 1.5, 2.5, 3.5, 4.5, 5.5 mm | 0.8, 1.5, 2.5, 3.5, 4.5, 5.5 mm | | | 0.8, 1.5, 2.5, 3.5, 4.5 mm |
| Prosthetic post<br>height | 4 mm and 6 mm | 4 mm and 6 mm | | | 4 mm |
| Prosthesis<br>attachment | Screw-retained single-unit, or<br>Cement-retained single or multi-unit | Cement-retained single-unit | | | Screw-retained single-unit, or<br>Cement-retained single or multi-unit |
| Material | Titanium alloy ASTM F136 | Titanium alloy ASTM F136 | | | Titanium alloy ASTM F136 |
| Implant interface | Interfaces exclusively to Neodent GM<br>implants | Interfaces exclusively to Neodent<br>GM implants | | | Interfaces exclusively to Neodent<br>CM Morse taper implants (11.5°<br>Morse taper) |
| Titanium Base | Titanium Base C for GM Exact | GM Exact Titanium Base | | Titanium Base for CEREC | |
| Body (prosthetic)<br>diameter | 4.65 mm | 3.5 mm and 4.5 mm | | 4.65 mm | |
| Abutment angle | Up to 20° | Up to 30° | | Up to 30° | |
| Gingival height | 0.8, 1.5, 2.5, 3.5, 4.5, 5.5 mm | 0.8, 1.5, 2.5, 3.5, 4.5, 5.5 mm | | 0.8, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5 mm | |
| Prosthetic post<br>height | 4.7 mm | 4 mm and 6 mm | | 4.7 mm | |
| Prosthesis<br>attachment | Cement-retained single-unit | Cement-retained single-unit | | Screw-retained single-unit | |
| Material | Titanium alloy ASTM F1…