NUVO IF Implant System

K193234 · Jjgc Industria E Comercio DE Materiais Dentarios S.A. · DZE · Jun 18, 2020 · Dental

Device Facts

• Record ID: K193234
• Device Name: NUVO IF Implant System
• Applicant: Jjgc Industria E Comercio DE Materiais Dentarios S.A.
• Product Code: DZE · Dental
• Decision Date: Jun 18, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The NUVO IF Implant System is intended to be surgically placed in the maxilla or mandible to provide support for prosthetic devices such as artificial teeth in order to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly splinted. The Titanium Temporary Abutment is indicated to provide temporary support for prosthesis structure for up to 6 months. The Attachment Equator and Attachment Removable Prosthesis are indicated for the attachment of full or partial dentures to NUVO implants. Titanium Base Abutment is a titanium base placed onto dental implants to provide support for customized prosthetic restorations. It is used with a coping and crown, or crown alone, and is indicated for cement or screw-retained single or multi-unit restorations or screw-retained single restorations. All digitally designed copings and/or crowns to be used with the Titanium Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center. The Rotational Titanium Base is indicated for cement or screw-retained multi-unit restorations. The CARES® Abutment is a customized prosthetic abutment, manufactured in titanium alloy, placed onto dental implants to provide support for customized prosthetic restorations (copings or crowns). It is indicated for cement-retained single restorations. All digitally designed abutments for use with the CARES® Abutment are intended to be sent to Straumann for manufacturing at a validated milling center.

Device Story

NUVO IF Implant System consists of endosseous dental implants, cover screws, and various abutments (temporary, attachment, titanium base, CARES®). Implants are surgically placed in maxilla or mandible by dental professionals to support prosthetic devices. Implants feature internal hexagonal interface, apically tapered thread-form, and sand-blasted/acid-etched surface. Abutments connect to implants to support final restorations (crowns, bridges, dentures). Titanium base abutments are two-piece systems (titanium base + CAD/CAM top-half). CARES® abutments are customized titanium alloy abutments. Digitally designed components are manufactured at validated milling centers. System restores chewing function and aesthetics. Benefits include rigid splinting for multiple teeth and immediate loading options. Used in clinical dental settings.

Clinical Evidence

Bench testing only. Dynamic fatigue testing performed per ISO 14801. Sterilization validated per ISO 11137-1/2 (gamma) and ISO 11135/17665-2 (EO/moist heat). Biocompatibility assessed per ISO 10993-1, -5, -7, and -18. Package integrity per ISTA 2A and stability per ASTM F1980. Endotoxin testing per ANSI/AAMI ST72.

Technological Characteristics

Materials: Commercially pure titanium (ASTM F67), Titanium alloy (ASTM F136), POM polymer, CoCr (ASTM F1537). Interface: Internal Hex. Surface: Sand-blasted/acid-etched (implants), machined/anodized (abutments). Sterilization: Gamma irradiation or Ethylene Oxide. CAD/CAM workflow: Digitally designed components manufactured at validated milling centers.

Indications for Use

Indicated for patients requiring dental implants in the maxilla or mandible to support prosthetic devices (artificial teeth) for chewing function restoration. Suitable for single/multiple unit restorations, single/two-stage procedures, and immediate loading if primary stability is achieved. Temporary abutments indicated for up to 6 months. Attachment abutments indicated for full/partial denture attachment. Titanium base and CARES® abutments indicated for customized prosthetic restorations (copings/crowns).

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 (K101945)

Reference Devices

• Medentika CAD/CAM Abutments (K150203)
• Neodent Implant System (K150367)
• Neodent Implant System (K153624)
• Neodent Implant System - GM Line (K163194)
• Neodent Implant System - GM Line (K173902)
• Straumann BLX Line Extension - New Abutments (K190040)
• Neodent Implant System - Temporary Abutments (K191191)
• Neodent Implant System – Neodent Titanium Base for Bridge (K192229)

Submission Summary (Full Text)

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June 18, 2020

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

Re: K193234

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

# Dear Jennifer Jackson:

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

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

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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K193234

Device Name NUVO IF Implant System

#### Indications for Use (Describe)

Indications for Use for NUVO IF Implants and conventional abutments:

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

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

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

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

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

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

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

Indications for Use for CARES® Abutment IF:

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

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

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary

# K193234

| ADMINISTRATIVE INFORMATION | |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor | JJGC Indústria e Comércio de Materiais Dentários SA<br>(dba Neodent)<br>Av. Juscelino Kubitschek de Oliveira, 3291<br>Curitiba, Parana, Brazil 81270-200<br>Registration No.: 3008261720<br>Owner/Operator No.: 10031702 |
| Contact Person | Jennifer M. Jackson, MS<br>Director of Regulatory Affairs,<br>Straumann USA<br>E-mail: [e-mail]<br>Telephone [phone] |
| Date Prepared | 17 June 2020 |
| Preparer / Alternate Contact | Luiza Vaccari Toppel<br>Regulatory Affairs Coordinator<br>JJGC Indústria e Comércio de Materiais Dentários SA<br>E-mail: [e-mail] |

# DEVICE NAME AND CLASSIFICATION

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

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### PREDICATE DEVICE INFORMATION

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

#### INDICATIONS FOR USE

Indications for Use for NUVO IF Implants and conventional abutments:

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

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

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

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

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

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

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

#### Indications for Use for CARES® Abutment IF:

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

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

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### SUBJECT DEVICE DESCRIPTIONS

### Implants

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

# Cover Screws

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

# Abutments

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

# SUBSTANTIAL EQUIVALENCE COMPARISON TABLES

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

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| Table 1. Substantial Equivalence -- Indication for Use Statements | | | | | | | |
|-------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-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| | SUBJECT DEVICES | PRIMARY PREDICATE | REFERENCE PREDICATES | | | | |
| COMPARISON | K193234<br>NUVO IF Implant System<br>JJGC Indústria e Comércio de Materiais<br>Dentários S.A. | K101945<br>Neodent Implant System –<br>CM Alvim Implant System<br>JJGC Indústria e Comércio de<br>Materiais Dentários S.A. | K150367<br>Neodent Implant System –<br>TiBase & Preface<br>JJGC Indústria e Comércio de<br>Materiais Dentários S.A. | K163194<br>Neodent Implant System –<br>GM Line<br>JJGC Indústria e Comércio de<br>Materiais Dentários S.A. | K192229<br>Neodent Implant System –<br>GM Titanium Base for<br>Bridge<br>JJGC Indústria e Comércio de<br>Materiais Dentários S.A. | K191191<br>Neodent Implant System –<br>Temporary Abutments<br>JJGC Indústria e Comércio de<br>Materiais Dentários S.A. | K190040<br>Straumann® PUREloc<br>abutments<br>Institut Straumann AG |
| Indications<br>for Use<br>Statement | Indications for Use for NUVO IF Implants<br>and conventional abutments:<br>The NUVO IF Implant System is intended to<br>be surgically placed in the maxilla or<br>mandible to provide support for prosthetic<br>devices such as artificial teeth in order to<br>restore chewing function. It may be used<br>with single-stage or two-stage procedures,<br>for single or multiple unit restorations, and<br>may be loaded immediately when good<br>primary stability is achieved and with<br>appropriate occlusal loading. Multiple<br>tooth applications may be rigidly splinted.<br><br>The Titanium Temporary Abutment is<br>indicated to provide temporary support for<br>prosthesis structure for up to 6 months.<br><br>The Attachment Equator and Attachment<br>Removable Prosthesis abutments are<br>indicated for the attachment of full or<br>partial dentures to NUVO implants.<br><br>Indications for Use for Rotational and Anti-<br>rotational Titanium Bases abutments:<br>Titanium Base Abutment is a titanium base<br>placed onto dental implants to provide<br>support for customized prosthetic<br>restorations. It is used with a coping and<br>crown, or crown alone, and is indicated for<br>cement-retained single or multi-unit<br>restorations or screw-retained single<br>restorations.<br><br>All digitally designed copings and/or<br>crowns to be used with the Titanium Base<br>Abutment System are intended to be sent | The Neodent Implant System<br>is intended to be surgically<br>placed in the bone of the<br>upper or lower jaw to<br>provide support for<br>prosthetic devices such as<br>artificial teeth, to restore<br>chewing function. It may be<br>used with single-stage or<br>two-stage procedures, for<br>single or multiple unit<br>restorations, and may be<br>loaded immediately when<br>good primary stability is<br>achieved and with<br>appropriate occlusal loading.<br>Multiple tooth applications<br>may be rigidly splinted. | Titanium Base Abutment is a<br>titanium base placed onto<br>Neodent dental implants to<br>provide support for<br>customized prosthetic<br>restorations. It is used with a<br>coping and crown, or crown<br>alone, and is indicated for<br>cement-retained single or<br>multi-unit restorations, or<br>screw-retained single<br>restorations.<br><br>PreFace Abutment is a<br>titanium abutment to be used<br>in fabricating a full custom<br>abutment and placed onto<br>Neodent dental implants to<br>provide support for<br>customized prosthetic<br>restorations.<br>PreFace Abutments are indicated for<br>screw-retained single<br>restorations or cement-<br>retained single or multi-unit<br>restorations. | Indications for Use for GM<br>implants and conventional<br>abutments:<br>The Neodent Implant System<br>is intended to be surgically<br>placed in the bone of the<br>upper or lower jaw to<br>provide support for<br>prosthetic devices such as<br>artificial teeth, to restore<br>chewing function. It may be<br>used with single-stage or<br>two-stage procedures, for<br>single or multiple unit<br>restorations, and may be<br>loaded immediately when<br>good primary stability is<br>achieved and with<br>appropriate occlusal loading.<br><br>Indications for Use for GM<br>Titanium Base abutments:<br>Titanium Base Abutment is a<br>titanium base placed onto<br>Neodent dental implants to<br>provide support for<br>customized prosthetic<br>restorations. It is used with a<br>coping and crown, or crown<br>alone, and is indicated for<br>cement-retained single or<br>multi-unit restorations, or<br>screw-retained single<br>restorations.<br><br>All digitally designed copings<br>and/or crowns for use with<br>the Neodent Titanium Base | Titanium Base Abutment is a<br>titanium base placed onto<br>Neodent dental implants to<br>provide support for<br>customized prosthetic<br>restorations. It is used with a<br>coping and crown, or crown<br>alone, and is indicated for<br>cement-retained single or<br>multi-unit restorations or<br>screw-retained single<br>restorations.<br><br>All digitally designed copings<br>and/or crowns to be used with the<br>Neodent Titanium Base<br>Abutment System are<br>intended to be sent to<br>Straumann for manufacture<br>at a validated milling center.<br>The GM Titanium Base for<br>Bridge is indicated for<br>cement or screw-retained<br>multi-unit restorations. | The Neodent Implant System<br>is intended to be surgically<br>placed in the bone of the<br>upper or lower jaw to<br>provide support for<br>prosthetic devices such as<br>artificial teeth, to restore<br>chewing function. It may be<br>used with single-stage or<br>two-stage procedures, for<br>single or multiple unit<br>restorations, and may be<br>loaded immediately when<br>good primary stability is<br>achieved and with<br>appropriate occlusal loading.<br><br>The Neodent Implant System<br>- Temporary Abutments are<br>indicated to be used on<br>Neodent implants to provide<br>temporary support for<br>prosthesis structure for up to<br>6 months. | The Straumann®<br>Retentive System is<br>indicated for the<br>attachment of full or<br>partial dentures on<br>Straumann implants |
| | SUBJECT DEVICES | PRIMARY PREDICATE | REFERENCE PREDICATES | | | | |
| COMPARISON | K193234<br>NUVO IF Implant System<br>JJGC Indústria e Comércio de Materiais<br>Dentários S.A. | K101945<br>Neodent Implant System -<br>CM Alvim Implant System<br>JJGC Indústria e Comércio de<br>Materiais Dentários S.A. | K150367<br>Neodent Implant System -<br>TiBase & Preface<br>JJGC Indústria e Comércio de<br>Materiais Dentários S.A. | K163194<br>Neodent Implant System -<br>GM Line<br>JJGC Indústria e Comércio de<br>Materiais Dentários S.A. | K192229<br>Neodent Implant System -<br>GM Titanium Base for<br>Bridge<br>JJGC Indústria e Comércio de<br>Materiais Dentários S.A. | K191191<br>Neodent Implant System -<br>Temporary Abutments<br>JJGC Indústria e Comércio de<br>Materiais Dentários S.A. | K190040<br>Straumann® PUREloc<br>abutments<br>Institut Straumann AG |
| | validated milling center.<br>The Rotational Titanium Base is indicated<br>for cement or screw-retained multi-unit<br>restorations.<br><br>Indications for Use for CARES® Abutment<br>IF:<br>The CARES® Abutment is a customized<br>prosthetic abutment, manufactured in<br>titanium alloy, placed onto dental implants<br>to provide support for customized<br>prosthetic restorations (copings or crowns).<br>It is indicated for screw-retained or<br>cement-retained single restorations.<br>All digitally designed abutments for use<br>with the CARES® Abutment are intended to<br>be sent to Straumann for manufacturing at | | | intended to be sent to<br>Straumann for manufacture<br>at a validated milling center.<br><br>Indications for Use for GM<br>Pro Peek Abutments:<br>The Pro PEEK Abutments are<br>indicated to be used on<br>Neodent implants to provide<br>temporary support for<br>prosthesis structure for up to<br>6 months. They can be used in<br>one or two stage procedures<br>and also immediate load when<br>there is good primary stability. | | | |

#### Table 1: Substantial Equivalence – Indication for Use Statements

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

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

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

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

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#### Table 2: Substantial Equivalence Comparison – Technological characteristics - Implants

| | SUBJECT DEVICES | PRIMARY PREDICATE | REFERENCE PREDICATE | |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | K193234 | K101945 | K163194 | |
| COMPARISON | NUVO IF Implant System<br>JJGC Indústria e Comércio de Materiais<br>Dentários S.A. | Neodent Implant System - CM Line<br>JJGC Indústria e Comércio de Materiais<br>Dentários S.A. | Neodent Implant System - GM Line<br>JJGC Indústria e Comércio de Materiais<br>Dentários S.A. | EQUIVALENCE DISCUSSION |
| Implant Type | Bone Level | Bone Level | | Same<br>The subject devices have the same external<br>design as the primary predicate. |
| Implant-to-<br>Abutment<br>Interface | Internal Hex | Cone Morse | | Equivalent<br>The implant interface is equivalent to that of<br>the predicate. Dynamic fatigue testing has<br>been performed to establish the performance<br>of the interface. |
| Implant<br>Diameter | 3.5 mm, 3.75 mm, 4.3 mm and 5.0 mm | 3.5 mm, 4.3 mm and 5.0 mm | 3.5 to 5.0 mm | Equivalent<br>The subject device diameters are in the range<br>of diameters of the primary and reference<br>predicate devices. |
| Implant Length | 3.5 mm: 7, 10, 11.5, 13, 16 & 18 mm<br>3.75 mm: 7, 10, 11.5, 13, 16 & 18 mm<br>4.3 mm: 7, 10, 11.5, 13, 16 & 18 mm<br>5.0 mm: 7, 10, 11.5, 13 & 16 mm | Alvim CM Implant<br>All diameters: 8, 10, 11.5, 13 & 16 mm<br><br>Titamax CM Implant<br>3.5 mm: 7, 8, 9, 11, 12, 15 & 17mm<br>3.75 mm: 7, 8, 9, 11, 12, 15 & 17mm<br>4.0 mm: 7, 8, 9, 11, 12, 15 & 17mm<br>5.0 mm: 7, 8, 9, 11, 12, 15 & 17mm | 8 to 18 mm | Equivalent<br>The subject device lengths are within the range<br>established by the primary and reference<br>predicate devices. |
| Thread Design | Apically Tapered, Dual Helix | Apically Tapered, Dual Helix<br>(Trade Name = Alvim) | | Same |
| Surface Finish | Sand blasted and acid etched | Sand blasted and acid etched<br>(Trade Name = Neoporos) | | Same |
| Material | Commercially Pure Titanium (Grade 4) | Commercially Pure Titanium (Grade 4) | | Same |
| Single Use | Yes | Yes | | Same |
| Sterilization<br>Method | Gamma Irradiation to an SAL of 1x10-6 | Gamma Irradiation to an SAL of 1x10-6 | | Same |
| | | | EQUIVALENCE DISCUSSION | |
| COMPARISON | SUBJECT DEVICES | PRIMARY PREDICATE | | |
| | K193234 | K101945 | | |
| | NUVO IF Implant System | Neodent Implant System - CM Alvim Implant System | | |
| | JJGC Indústria e Comércio de Materiais Dentários S.A. | JJGC Indústria e Comércio de Materiais Dentários S.A. | |…