Neodent Implant System - GM Narrow Implant System

K220251 · Jjgc Industria E Comercio DE Materiais Dentarios S.A. · DZE · Sep 6, 2022 · Dental

Device Facts

• Record ID: K220251
• Device Name: Neodent Implant System - GM Narrow Implant System
• Applicant: Jjgc Industria E Comercio DE Materiais Dentarios S.A.
• Product Code: DZE · Dental
• Decision Date: Sep 6, 2022
• 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. The Implant Narrow GM is indicated to replace upper lateral incisors, lower incisors or for retaining overdenture prostheses. 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. Prosthetic component to be installed in the Narrow GM Implant, providing support for prosthetic structures. Indicated for temporary restorations with unitary structures, screwed, on implants installed in the maxilla or mandible. Temporary Abutments Narrow GM have a maximum duration of usage of 180 days. Titanium Base Abutment is a titanium base placed onto Neodent dental implants to provide support for customized prosthetic restorations as copings and crowns. It is indicated for cemented or screw mounted single-cemented applications on implants installed on the maxilla or mandible. 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.

Device Story

The Neodent Implant System consists of endosseous dental implants and associated abutments (conventional, temporary, and titanium bases). Implants are surgically placed into the jawbone by a dental professional to support prosthetic devices like artificial teeth. The system uses a Grand Morse internal connection interface. Implants are cylindrical with double threads and are available with Neoporos (sand-blasted/acid-etched) or Acqua (hydrophilic) surfaces. Titanium bases support customized CAD/CAM copings or crowns manufactured at a validated milling center. The device restores chewing function and aesthetics for patients with missing teeth. Clinical benefit is achieved through osseointegration of the implant, providing a stable foundation for prosthetic restorations. The system supports immediate loading protocols when primary stability is sufficient.

Clinical Evidence

Bench testing only. Evidence includes dynamic fatigue testing per ISO 14801, biocompatibility assessment (ISO 10993-1, -5, -12, -18), and sterilization validation (ISO 11137, ISO 11135). No clinical data was required or provided.

Technological Characteristics

Implants: Commercially Pure Titanium (Grade 4). Abutments: Titanium alloy (ASTM F136). Interface: Grand Morse internal connection. Surface: Neoporos or Acqua. Sterilization: Gamma irradiation (implants) or Ethylene Oxide (abutments) to SAL 10^-6. Dimensions: 2.9 mm diameter.

Indications for Use

Indicated for patients requiring dental implants in the upper or lower jaw for prosthetic support (single/multiple units, overdentures). Specifically for Narrow GM implants: replacement of upper lateral incisors, lower incisors, or overdenture retention. Temporary abutments limited to 180 days use. Titanium bases for cemented/screw-mounted single-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 (K123022)
• NUVO CF Implant System (K203309)

Reference Devices

• Straumann Ø2.9 mm Bone Level Tapered Implants, SC Closure Cap, SC Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutments (K162890)
• MRI Compatibility For Existing Neodent Implant System (K182620)

Submission Summary (Full Text)

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

Re: K220251

Trade/Device Name: Neodent Implant System - GM Narrow Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: August 4, 2022 Received: August 9, 2022

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.

Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K220251

#### Device Name

Neodent Implant System - GM Narrow Implant System

#### Indications for Use (Describe)

IIndications for Use for Helix NGM Implants:

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. The Implant Narrow GM is indicated to replace upper lateral incisors, lower incisors or for retaining overdenture prostheses.

#### Indications for Conventional Abutments:

The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

Indications for Use for NGM Exact Temporary Abutments:

Prosthetic component to be installed in the Narrow GM Implant, providing support for prosthetic structures. Indicated for temporary restorations with unitary structures, screwed, on implants installa or mandible. Temporary Abutments Narrow GM have a maximum duration of usage of 180 days.

Indications for NGM Exact Titanium Bases:

Titanium Base Abutment is a titanium base placed onto Neodent dental implants to provide support for customized prosthetic restorations as copings and crowns. It is indicated for cemented or screw mounted single-cemented applications on implants installed on the maxilla or mandible. 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.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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## K220251 510(k) Summary

## 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>Sr. Director of Regulatory Affairs and Quality,<br>Straumann USA<br>E-mail: <a href="mailto:[e-mail]">[e-mail]</a><br>Telephone [phone] |
| Date Prepared | 06/Sep/2022 |
| Preparer / Alternate Contact | Mariana Hartmann<br>Regulatory Affairs Analyst<br>JJGC Indústria e Comércio de Materiais Dentários SA<br>E-mail: <a href="mailto:[e-mail]">[e-mail]</a> |

DEVICE NAME AND CLASSIFICATION

| Trade/ Proprietary Name | Neodent Implant System – GM Narrow Implant System |
|----------------------------|----------------------------------------------------------------------|
| Common Name | Endosseous dental implant<br>Endosseous dental implant abutment |
| Classification Name | Implant, Endosseous, Root-Form<br>Endosseous dental implant abutment |
| Classification Regulations | 21 CFR 872.3640, Class II |
| Product Code | DZE / NHA |
| Classification Panel | Dental Products Panel |
| Reviewing Branch | Dental Devices Branch |

PREDICATE DEVICE INFORMATION

| Primary Predicate Device | K123022, Neodent Implant System, JJGC Indústria e<br>Comércio de Materiais Dentários S.A |
|--------------------------|------------------------------------------------------------------------------------------|
|--------------------------|------------------------------------------------------------------------------------------|

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| Reference Predicate Devices | |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | K162890 - Straumann Ø2.9 mm Bone Level Tapered<br>Implants, SC Closure Cap, SC Healing Abutments, SC<br>Temporary Abutments, SC Variobase Abutments, SC<br>CARES Abutments - Straumann USA, LLC |
| | K203309 – NUVO CF Implant Line, JJGC Indústria e<br>Comércio de Materiais Dentários S.A |
| | K182620 - MRI Compatibility For Existing Neodent<br>Implant System, JJGC Indústria e Comércio de Materiais<br>Dentários S.A |

### INDICATIONS FOR USE

### Indications for Use for Helix NGM Implants:

The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single stage or two-stage procedures, for single- or multiple-unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. The Implant Narrow GM is indicated to replace upper lateral incisors, lower incisors or for retaining overdenture prostheses.

### Indications for Conventional Abutments:

The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

#### Indications for Use for NGM Exact Temporary Abutments:

Prosthetic component to be installed in the Narrow GM Implant, providing support for prosthetic structures. Indicated for temporary restorations with unitary structures, screwed, on implants installed in the maxilla or mandible. Temporary Abutments Narrow GM have a maximum duration of usage of 180 days.

#### Indications for NGM Exact Titanium Bases:

Titanium Base Abutment is a titanium base placed onto Neodent dental implants to provide support for customized prosthetic restorations as copings and crowns. It is indicated for cemented or screw mounted single-cemented applications on implants installed on the maxilla or mandible. 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.

#### SUBJECT DEVICE DESCRIPTIONS

- All the subject devices are intended for single use;
- The subject implants are provided sterile via gamma irradiation and the subject abutments are provided sterile via Ethylene Oxide to an SAL of 1x10 -;
- The subject implants are manufactured of Commercially Pure Titanium (Grade 4) and the subject abutments are manufactured of Titanium alloy Ti-6Al-4V ELI (ASTM F136),
- The subject implants present a Grand Morse prosthetic interface with internal indexer; cylindrical shape with double threads; cervical diameter equal to the implant body diameter (2.9 mm)

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- The implants are provided in two different surfaces: Neoporos: Sand blasted and acid etched, and Acqua: Hydrophilic surface aggregated to the rough surface obtained by double treatment: abrasive blasting and acid subtraction.
### 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 Comparison – Indix NGM Implants and Conventional and Temporary Abutments

| | SUBJECT DEVICES | PRIMARY PREDICATE | REFERENCE PREDICATE DEVICE |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| COMPARISON | Neodent Implant System - Narrow Implant System<br>JJGC Indústria e Comércio de Materiais Dentários S.A. | K123022<br>Neodent Implant System<br>JJGC Indústria e Comércio de Materiais Dentários S.A. | K162890<br>Straumann Ø2.9 mm Bone Level Tapered<br>Implants, SC Closure Cap, SC Healing<br>Abutments, SC Temporary Abutments, SC<br>Variobase Abutments, SC CARES Abutments<br>Straumann USA, LLC |
| Indications<br>for Use<br>Statement | Indications for Use for Helix NGM Implants:<br>The Neodent Implant System is intended to be surgically<br>placed in the bone of the upper or lower jaw to provide<br>support for prosthetic devices, such as artificial teeth, to<br>restore chewing function. It may be used with single stage or<br>two-stage procedures, for single- or multiple-unit<br>restorations, and may be loaded immediately when good<br>primary stability is achieved and with appropriate occlusal<br>loading. The Implant Narrow GM is indicated to replace upper<br>lateral incisors, lower incisors or for retaining overdenture<br>prostheses.<br>Indications for Use for Conventional Abutments:<br>The Neodent Implant System is intended to be surgically<br>placed in the bone of the upper or lower jaw to provide<br>support for prosthetic devices, such as artificial teeth, to<br>restore chewing function. It may be used with single-stage or<br>two-stage procedures, for single or multiple unit restorations,<br>and may be loaded immediately when good primary stability<br>is achieved and with appropriate occlusal loading.<br>Indications for Use for NGM Exact Temporary Abutments:<br>Prosthetic component to be installed in the Narrow GM<br>Implant, providing support for prosthetic structures. Indicated<br>for temporary restorations with unitary structures, screwed,<br>on implants installed in the maxilla or mandible. Temporary<br>Abutments Narrow GM have a maximum duration of usage of<br>180 days.<br>Indications for Use for NGM Exact Titanium Bases:<br>Titanium Base Abutment is a titanium base placed onto<br>Neodent dental implants to provide support for customized<br>prosthetic restorations as copings and crowns. It is indicated | The Neodent Implant System is intended to be surgically<br>placed in the bone of the upper or lower jaw to provide<br>support for prosthetic devices, such as artificial teeth, to<br>restore chewing function. It may be used with single<br>stage or two-stage procedures, for single- or multiple-<br>unit restorations, and may be loaded immediately when<br>good primary stability is achieved and with appropriate<br>occlusal loading.<br>Titamax WS implant is indicated for a delayed loading<br>protocol.<br>The Facility implant is indicated to replace upper lateral<br>incisors, lower incisors or for retaining overdenture<br>prostheses. | Straumann® Bone Level Tapered Implants Ø2.9 mm are indicated for<br>oral endosteal implantation in the upper and lower jaw and for the<br>functional and aesthetic oral rehabilitation of patients with missing<br>teeth. Straumann® Bone Level Tapered Implants Ø2.9 mm can also<br>be used for immediate or early implantation following extraction or<br>loss of natural teeth. Implants can be placed with immediate<br>function on single-tooth or multiple-tooth applications when good<br>primary stability is achieved and with appropriate occlusal loading<br>to restore chewing function. The prosthetic restorations are<br>connected to the implants through the corresponding components<br>(abutments). The Straumann® Bone Level Tapered Implants Ø2.9<br>mm are indicated for reconstruction of missing incisors in the lower<br>jaw and lateral incisors in the upper jaw.<br>Straumann® Closure Caps and Healing Abutments are indicated to<br>be placed in the dental implant after placement in the patient's jaw<br>to protect the inner configuration of the implant and to form,<br>maintain and stabilize the soft tissue during the healing process.<br>Closure Caps and Healing Abutments should be used only with the<br>corresponding implant connection.<br>Straumann® SC Temporary Abutments are indicated for use as an<br>aid in prosthetic rehabilitations. Temporary components can be<br>used prior to the insertion of the final components to maintain,<br>stabilize and shape the soft tissue during the healing phase.<br>Straumann® SC Temporary Abutments have a maximum duration of<br>usage of 180 days.<br>Straumann® SC Variobase® abutments are indicated for use as an aid<br>in prosthetic rehabilitations. The prosthetic restoration can be<br>cemented on the Straumann® SC Variobase® prosthetic |
| | SUBJECT DEVICES | PRIMARY PREDICATE | REFERENCE PREDICATE DEVICE |
| COMPARISON | Neodent Implant System - Narrow Implant System<br>JJGC Indústria e Comércio de Materiais Dentários S.A. | K123022<br>Neodent Implant System<br>JJGC Indústria e Comércio de Materiais Dentários S.A. | K162890<br>Straumann Ø2.9 mm Bone Level Tapered<br>Implants, SC Closure Cap, SC Healing<br>Abutments, SC Temporary Abutments, SC<br>Variobase Abutments, SC CARES Abutments<br>Straumann USA, LLC |
| | for cemented or screw mounted single-cemented applications<br>on implants installed on the maxilla or mandible. All digitally<br>designed copings and/or crowns to be used with the Titanium<br>Base Abutment System are intended to be sent to Straumann<br>for manufacture at a validated milling center. | | components. A temporary restoration can be used prior to the<br>insertion of the final components to maintain, stabilize and form the<br>soft tissue during the healing phase. Final abutments and<br>restorations may be placed into occlusion when the implant is fully<br>osseointegrated. All digitally designed copings and/or crowns for use<br>with the Straumann® Variobase® Abutment system are intended to<br>be sent to Straumann for manufacture at a validated milling center.<br><br>Straumann® SC CARES® abutments are indicated for single-tooth<br>replacements and multiple tooth restorations. The prosthetic<br>restoration can be cemented or directly veneered/screw-retained. |

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#### Neodent Implant System – GM Narrow Implant System

#### Table 2: Substantial Equivalence Comparison – Indication for Use Statements - Titanium Bases

| COMPARISON | SUBJECT DEVICES | PRIMARY PREDICATE | REFERENCE PREDICATE DEVICE |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | K203309 | K162890 |
| | Neodent Implant System - Narrow Implant System<br>JJGC Indústria e Comércio de Materiais Dentários S.A. | NUVO CF Implant System<br>JJGC Indústria e Comércio de Materiais<br>Dentários S.A. | Straumann Ø2.9 mm Bone Level Tapered<br>Implants, SC Closure Cap, SC Healing<br>Abutments, SC Temporary Abutments, SC<br>Variobase Abutments, SC CARES Abutments<br>Straumann USA, LLC |
| Indications<br>for Use<br>Statement | Indications for Use for NGM Exact Titanium Bases:<br>Titanium Base Abutment is a titanium base placed onto<br>Neodent dental implants to provide support for customized<br>prosthetic restorations as copings and crowns. It is indicated<br>for cemented or screw mounted single-cemented applications<br>on implants installed on the maxilla or mandible. All digitally<br>designed copings and/or crowns to be used with the Titanium<br>Base Abutment System are intended to be sent to Straumann<br>for manufacture at a validated milling center. | CF Titanium Base for Crown is a titanium abutment placed<br>onto dental implants to provide support for customized<br>prosthetic restorations, as copings or crowns. It is indicated<br>for single-unit restorations, cement-retained or screw-<br>retained in aesthetic areas on implants installed in the<br>maxilla or mandible. All digitally designed copings and/or<br>crowns to be used with the Titanium Base Abutment System<br>are intended to be sent to Straumann for manufacture at a<br>validated milling center. | Straumann® SC Variobase® abutments are indicated for use as an aid in<br>prosthetic rehabilitations. The prosthetic restoration can be cemented<br>on the Straumann® SC Variobase® prosthetic components. A temporary<br>restoration can be used prior to the insertion of the final components to<br>maintain, stabilize and form the soft tissue during the healing phase.<br>Final abutments and restorations may be placed into occlusion when the<br>implant is fully osseointegrated. All digitally designed copings and/or<br>crowns for use with the Straumann® Variobase® Abutment system are<br>intended to be sent to Straumann for manufacture at a validated milling<br>center. |

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### Equivalence Discussion about Indications for Use

### Implants

The scope of the Indications for Use Statement for the subject Implants (K220251) are identical to the corresponding section of the Indications for Use Statement of the Facility Implant of primary predicate devices (K123022) and similar to the reference predicate devices (K162890).

| | PRIMARY PREDICATE DEVICE | REFERENCE PREDICATE DEVICE |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SUBJECT DEVICE | K123022 | K162890 |
| The Neodent Implant System is<br>intended to be surgically placed in<br>the bone of the upper or lower<br>jaw to provide support for<br>prosthetic devices, such as<br>artificial teeth, to restore chewing<br>function. It may be used with<br>single stage or two-stage<br>procedures, for single- or<br>multiple-unit restorations, and<br>may be loaded immediately when<br>good primary stability is achieved<br>and with appropriate occlusal<br>loading. The Implant Narrow GM<br>is indicated to replace upper<br>lateral incisors, lower incisors or<br>for retaining<br>overdenture<br>prostheses. | The Neodent Implant System is<br>intended to be surgically placed in<br>the bone of the upper or lower jaw<br>to provide support for prosthetic<br>devices, such as artificial teeth, to<br>restore chewing function. It may<br>be used with single stage or two-<br>stage procedures, for single- or<br>multiple-unit restorations, and<br>may be loaded immediately when<br>good primary stability is achieved<br>and with appropriate occlusal<br>loading.<br>Titamax WS implant is indicated<br>for a delayed loading protocol.<br>The Facility implant is indicated to<br>replace upper lateral incisors,<br>lower incisors or for retaining<br>overdenture prostheses. | Straumann® Bone Level Tapered Implants Ø2.9 mm<br>are indicated for oral endosteal implantation in the<br>upper and lower jaw and for the functional and<br>aesthetic oral rehabilitation of patients with missing<br>teeth. Straumann® Bone Level Tapered Implants<br>Ø2.9 mm can also be used for immediate or early<br>implantation following extraction or loss of natural<br>teeth. Implants can be placed with immediate<br>function on single-tooth or multiple-tooth<br>applications when good primary stability is achieved<br>and with appropriate occlusal loading to restore<br>chewing function. The prosthetic restorations are<br>connected to the implants through the<br>corresponding components (abutments). The<br>Straumann® Bone Level Tapered Implants Ø2.9 mm<br>are indicated for reconstruction of missing incisors<br>in the lower jaw and lateral incisors in the upper jaw. |

#### Conventional and Temporary Abutments

The indications for use of the Conventional Abutments is the same for the subject devices and primary predicate device (K123022). Regarding the Temporary Abutments, although the wording is slightly different, the indications for use are the same (K162890).

| SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE PREDICATE DEVICE |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | K123022 | K162890 |
| Conventional Abutments: | Conventional Abutments: | Temporary Abutments: |
| The Neodent Implant System is intended to be<br>surgically placed in the bone of the upper or<br>lower jaw to provide support for prosthetic<br>devices, such as artificial teeth, to restore<br>chewing function. It may be used with single-<br>stage or two-stage procedures, for single or<br>multiple unit restorations, and may be loaded<br>immediately when good primary stability is<br>achieved and with appropriate occlusal loading.<br><br>Temporary Abutments: | The Neodent Implant System is intended<br>to be surgically placed in the bone of the<br>upper or lower jaw to provide support<br>for prosthetic devices, such as artificialteeth, to restore chewing function. It<br>may be used with single-stage or two-<br>stage procedures, for single or multiple<br>unit restorations, and may be loaded<br>immediately<br>when good primary<br>stability is achieved and with<br>appropriate occlusal loading. | Straumann® SC Temporary<br>Abutments are indicated for use as<br>an aid in prosthetic rehabilitations.<br>Temporary components can be<br>used prior to the insertion of the<br>final components to maintain,<br>stabilize and shape the soft tissue<br>during the healing phase.<br>Straumann® SC Temporary<br>Abutments have a maximum<br>duration of usage of 180 days. |
| Prosthetic component to be installed in the<br>Narrow GM Implant, providing support for<br>prosthetic structures. Indicated for temporary<br>restorations with unitary structures, screwed,<br>on implants installed in the maxilla or mandible.<br>Temporary Abutments Narrow GM have a<br>maximum duration of usage of 180 days. | | |

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### Titanium Bases Abutments

The Indications for Use Statement for the subject device are equivalent to the corresponding section of the Indications for Use Statement of K203309 and K162890. Although the wording is slightly different, the Indications for the subject devices are included within the scope on Indications for the predicate devices.

| SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE PREDICATE DEVICE |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | K203309 | K162890 |
| Titanium Base Abutment is a<br>titanium base placed onto Neodent<br>dental implants to provide support<br>for customized prosthetic<br>restorations as copings and crowns.<br>It is indicated for cemented or screw<br>mounted single-cemented<br>applications on implants installed on<br>the maxilla or mandible.<br>All digitally designed copings and/or<br>crowns to be used with the Titanium<br>Base Abutment System are intended<br>to be sent to Straumann for<br>manufacture at a validated milling<br>center. | CF Titanium Base for Crown is a titanium<br>abutment placed onto dental implants to<br>provide support for customized prosthetic<br>restorations, as copings or crowns. It is<br>indicated for single-unit restorations,<br>cement-retained or screw-retained in<br>aesthetic areas on implants installed in the<br>maxilla or mandible. All digitally designed<br>copings and/or crowns to be used with the<br>Titanium Base Abutment System are<br>intended to be sent to Straumann for<br>manufacture at a validated milling<br>center. | Straumann® SC Variobase®<br>abutments are indicated for use as an<br>aid in prosthetic rehabilitations. The<br>prosthetic restoration can be<br>cemented on the Straumann® SC<br>Variobase® prosthetic components. A<br>temporary restoration can be used<br>prior to the insertion of the final<br>components to maintain, stabilize and<br>form the soft tissue during the healing<br>phase. Final abutments and<br>restorations may be placed into<br>occlusion when the implant is fully<br>osseointegrated. All digitally designed<br>copings and/or crowns for use with the<br>Straumann® Variobase® Abutment<br>system are intended to be sent to<br>Straumann for manufacture at a<br>validated milling center. |

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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## TECHNOLOGICAL CHARACTERISTIC COMPARISON TABLES

| | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE PREDICATE DEVICE | Equivalence Discussion |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Implant-<br>Abutment<br>interface | K220251<br>Neodent Implant System - Narrow Implant<br>System<br>JJGC Indústria e Comércio de Materiais<br>Dentários S.A. | K123022<br>Neodent Implant System<br>JJGC Indústria e Comércio de Materiais<br>Dentários S.A. | K162890<br>Straumann Ø2.9 mm Bone Level Tapered<br>Implants, SC Closure Cap, SC Healing<br>Abutments, SC Temporary Abutments, SC<br>Variobase Abutments, SC CARES Abutments<br>Straumann USA, LLC | Similar<br>All the devices have Internal implant to<br>abutment connection. The difference<br>between the primary predicate and the<br>subject devices has been proven to<br>increase the system resistance (bench<br>testings). |
| Design | Grand Morse Internal Conn…