Neodent Implant System - Change in the Shelf Life of Neodent Acqua Implants

K193592 · Jjgc Industria E Comercio DE Materiais Dentarios S.A. · DZE · Apr 28, 2020 · Dental

Device Facts

• Record ID: K193592
• Device Name: Neodent Implant System - Change in the Shelf Life of Neodent Acqua Implants
• Applicant: Jjgc Industria E Comercio DE Materiais Dentarios S.A.
• Product Code: DZE · Dental
• Decision Date: Apr 28, 2020
• Decision: SESE
• Submission Type: Special
• 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 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.

Device Story

Neodent Implant System consists of threaded, root-form dental implants manufactured from commercially pure titanium grade 4. Implants feature Acqua surface treatment to enhance hydrophilicity. Devices are surgically placed into the jawbone by dental professionals to support prosthetic restorations (artificial teeth). The system supports single-stage procedures and immediate loading protocols. This submission specifically extends the validated shelf life of Acqua-treated implants from 2 to 4 years based on real-time aging studies. Implants are provided sterile via gamma irradiation for single use. Clinical benefit includes restoration of chewing function and prosthetic support.

Clinical Evidence

Bench testing only. Real-time aging study conducted to validate 4-year shelf life. Testing included: hydrophilicity (dynamic contact angle < 5°), package integrity (ASTM F1929 dye penetration, ASTM F2096 bubble test, ASTM F88 sealing strength), and biological safety (ISO 10993-1, ISO 10993-5 cytotoxicity). All tests met acceptance criteria.

Technological Characteristics

Commercially pure titanium grade 4; threaded root-form design; Morse taper or external hex interface; Acqua surface treatment; gamma irradiation (25 kGy min) sterilization; shelf life 4 years.

Indications for Use

Indicated for patients requiring dental implants in the upper or lower jaw to support prosthetic devices (artificial teeth) and restore chewing function. Suitable for single-stage procedures, single or multiple unit restorations, and immediate loading when primary stability is achieved. Facility implant specifically indicated for replacement of maxillary lateral incisors, mandibular incisors, or retention of overdentures. Pro PEEK Abutments indicated for temporary support for up to 6 months.

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 (K133592)
• Neodent Implant System - CM Drive Implants (K150182)
• Neodent Implant System (K150199)
• Neodent Implant System - GM Line (K163194)
• Neodent Implant System - GM Line (K180536)

Reference Devices

• MRI Compatibility For Existing Neodent Implant System (K182620)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

April 28, 2020

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: K193592

Trade/Device Name: Neodent Implant System - Change in the Shelf Life of Neodent Acqua Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: April 10, 2020 Received: April 13, 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.

{1}------------------------------------------------

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 (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 (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 Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

510(k) Number (if known) K193592

Device Name

Neodent Implant System - Change in the Shelf Life of Neodent Acqua Implants

Indications for Use (Describe)

- Neodent Implant System (originally cleared per K133592)

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. Multiple tooth applications may be rigidly splinted.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| <div> <span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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

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

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

{3}------------------------------------------------

510(k) Number (if known) K193592

Device Name

Neodent Implant System - Change in the Shelf Life of Neodent Acqua Implants

Indications for Use (Describe)

- Neodent Implant System (originally cleared per K150182)

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.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| <div> <span> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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

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

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

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

#### 510(k) Number (if known) K193592

#### Device Name

Neodent Implant System - Change in the Shelf Life of Neodent Acqua Implants

#### Indications for Use (Describe)

- Neodent Implant System (originally cleared per K150199)

### CM Alvim Acqua Implant

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. Multiple tooth applications may be rigidly splinted.

#### Facility Acqua Implant

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 Facility implant is indicated for replacement of maxillary lateral incisors, mandibular incisors or retention of overdentures.

CM Anatomic Abutment, Exact Anatomic, Lateral Anatomic, and Lateral Anatomic Abutments

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

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

| <span style="font-size:100%;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|-------------------------------------------------------------------------------------|-----------------------------------------------|
|-------------------------------------------------------------------------------------|-----------------------------------------------|

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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

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

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

{5}------------------------------------------------

### 510(k) Number (if known) K193592

Device Name

Neodent Implant System - Change in the Shelf Life of Neodent Acqua Implants

#### Indications for Use (Describe)

- Neodent Implant System - GM Line (originally cleared per K163194)

Indications for Use for GM implants and conventional abutments:

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

Indications for Use for GM Titanium Base abutments:

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

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

Indications for Use for GM Pro Peek Abutments:

The Pro PEEK Abutments are indicated to be used on Neodent implants to provide temporary support for prosthesis structure for up to 6 months. They can be used in one or two stage procedures and also immediate load when there is good primary stability.

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

| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|----------------------------------------------|---------------------------------------------|
|----------------------------------------------|---------------------------------------------|

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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

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

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

{6}------------------------------------------------

### 510(k) Number (if known) K193592

Device Name

Neodent Implant System - Change in the Shelf Life of Neodent Acqua Implants

Indications for Use (Describe)

- Neodent Implant System - GM Line (originally cleared per K180536)

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 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 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 cemented-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 cemented-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.

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)

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

{7}------------------------------------------------

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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

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

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

{8}------------------------------------------------

K193592 - Neodent Implant System – Change in the Shelf Life of Neodent Acqua Implants

| 510(k) Summary | |
|-------------------------------------------|--------------------------------------------------------------------------------------------|
| ADMINISTRATIVE INFORMATION | |
| Sponsor | JJGC Indústria e Comércio de Materiais Dentários SA |
| | (dba Neodent) |
| | Av. Juscelino Kubitschek de Oliveira, 3291 |
| | Curitiba, Parana, Brazil 81270-200 |
| | Registration No.: 3008261720 |
| | Owner/Operator No.: 10031702 |
| Contact Person | Jennifer M. Jackson, MS |
| | Director of Regulatory Affairs, |
| | Straumann USA |
| | E-mail: [e-mail] |
| | Telephone [phone] |
| Date Prepared | 28/Apr/2020 |
| Preparer / Alternate Contact | Mariana Soares Hartmann |
| | Regulatory Affairs Analyst |
| | E-mail: [e-mail] |
| DEVICE NAME AND CLASSIFICATION | |
| Trade/ Proprietary Name<br>Acqua Implants | Neodent Implant System – Change in the Shelf Life for Neodent |
| Common Name | Endosseous dental implant |
| Classification Name | Implant, Endosseous, Root-Form |
| Classification Regulations | 21 CFR 872.3640, Class II |
| Product Code | DZE |
| Classification Panel | Dental Products Panel |
| Reviewing Branch | Dental Devices Branch |
| PREDICATE DEVICE INFORMATION | |
| Predicate Devices | K133592 – Neodent Implant System, JJGC Indústria e Comércio de<br>Materiais Dentários S.A. |

{9}------------------------------------------------

K150182 - Neodent Implant System - CM Drive Implants, JJGC Indústria e Comércio de Materiais Dentários S.A;

K150199 – Neodent Implant System, JJGC Indústria e Comércio de Materiais Dentários S.A;

K163194, Neodent Implant System - GM Line, JJGC Indústria e Comércio de Materiais Dentários S.A;

K180536, Neodent Implant System – GM Line, JJGC Indústria e Comércio de Materiais Dentários S.A.

K182620, MRI Compatibility For Existing Neodent Implant System, JJGC Indústria e Comércio de Materiais Dentários S.A.

## INDICATIONS FOR USE

## Indications for Use K133592

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

### Indications for Use K150182

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 K150199

## CM Alvim Acqua Implant

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

### Facility Acqua Implant

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 Facility implant is indicated for replacement of maxillary lateral incisors, mandibular incisors or retention of overdentures.

CM Anatomic Abutment, Exact Anatomic, Lateral Anatomic, and Lateral Anatomic Abutments

{10}------------------------------------------------

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 K163194

Indications for Use for GM implants and conventional abutments:

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

## Indications for Use for GM Titanium Base abutments:

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

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

## Indications for Use for GM Pro Peek Abutments:

The Pro PEEK Abutments are indicated to be used on Neodent implants to provide temporary support for prosthesis structure for up to 6 months. They can be used in one or two stage procedures and also immediate load when there is good primary stability.

## Indications for Use K180536

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.

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 screwretained single restorations or cemented-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 cemented-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.

{11}------------------------------------------------

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 DESCRIPTIONS

The present submission is for an increase in the shelf life of the Neodent Implant System having the Acqua surface treatment; the shelf life is being extended from 2-years.

The subject devices are:

- Intended for single use;
- Provided sterile via gamma irradiation;
- Manufactured of commercially pure titanium grade 4;
- Root-form, threaded implants with Acqua surface treatment;
- Compatible with several implant-to-abutment interfaces of the Neodent Implant System as presented in the Comparison Tables below.

{12}------------------------------------------------

# TECHNOLOGICAL CHARACTERISTIC COMPARISON TABLE

| | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Neodent Implant System - Change in the Shelf Life for<br>Neodent Acqua Implants<br>JJGC Indústria e Comércio de Materiais Dentários S.A. | K133592<br>Neodent Implant System<br>JJGC Indústria e Comércio de Materiais Dentários S.A. |
| Indications for<br>Use | 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 unit<br>restorations, and may be loaded immediately when good<br>primary stability is achieved and with appropriate<br>occlusal loading. Multiple tooth applications may be<br>rigidly splinted. | 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 unit<br>restorations, and may be loaded immediately when good<br>primary stability is achieved and with appropriate<br>occlusal loading. Multiple tooth applications may be<br>rigidly splinted. |
| Design | An external hex threaded root-form implant to be used<br>with mating abutments having an integral anti-rotation<br>feature. | An external hex threaded root-form implant to be used<br>with mating abutments having an integral anti-rotation<br>feature. |
| Reusable | No | No |
| Dimensions | Titamax Ti EX Acqua and Titamax Smart EX Acqua:<br>Implant Ø: 3.75, 4.0 mm<br>Length: 9, 11, 13, 15, 17 mm<br>Platform Ø: 4.1 mm<br><br>Drive Ti Acqua and Drive Smart Acqua:<br>Implant Ø: 3.5, 4.3, 5.0 mm<br>Length: 8, 10, 11.5, 13, 16<br>mm<br>Platform Ø: 3.3, 4.3, 5.0 mm<br><br>Titamax CM EX Acqua:<br>Implant Ø: 3.5, 3.75, 4.0mm<br>Length: 9, 11, 13, 15, 17, 19 mm<br>Platform Ø: 3.5, 3.75, 4.0mm<br><br>Drive CM Acqua:<br>Implant Ø: 3.5, 4.3, 5.0 mm<br>Length: 8, 10, 11.5, 13, 16 mm<br>Platform Ø: 3.5, 3.9 mm | Titamax Ti EX Acqua and Titamax Smart EX Acqua:<br>Implant Ø: 3.75, 4.0 mm<br>Length: 9, 11, 13, 15, 17 mm<br>Platform Ø: 4.1 mm<br><br>Drive Ti Acqua and Drive Smart Acqua:<br>Implant Ø: 3.5, 4.3, 5.0 mm<br>Length: 8, 10, 11.5, 13, 16<br>mm<br>Platform Ø: 3.3, 4.3, 5.0 mm<br><br>Titamax CM EX Acqua:<br>Implant Ø: 3.5, 3.75, 4.0mm<br>Length: 9, 11, 13, 15, 17, 19 mm<br>Platform Ø: 3.5, 3.75, 4.0mm<br><br>Drive CM Acqua:<br>Implant Ø: 3.5, 4.3, 5.0 mm<br>Length: 8, 10, 11.5, 13, 16 mm<br>Platform Ø: 3.5, 3.9 mm |
| Material | Commercially pure titanium, grade 4 | Commercially pure titanium, grade 4 |
| Sterilization<br>Method | Gamma irradiation, 25 kGy min. | Gamma irradiation, 25 kGy min. |
| Shelf Life | 4 years | 2 years |

| Table 1. Comparative table between subject implants and previously cleared implants per K133592 | | | |
|-------------------------------------------------------------------------------------------------|--|--|--|
| | | | |

{13}------------------------------------------------

| | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Neodent Implant System - Change in the Shelf Life for<br>Neodent Acqua Implants<br>JJGC Indústria e Comércio de Materiais Dentários S.A. | K150182<br>Neodent Implant System - CM Drive Implants<br>JJGC Indústria e Comércio de Materiais Dentários S.A. |
| Indications for<br>Use | 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 unit<br>restorations, and may be loaded immediately when good<br>primary stability is achieved and with appropriate<br>occlusal loading. | 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 unit<br>restorations, and may be loaded immediately when good<br>primary stability is achieved and with appropriate<br>occlusal loading. |
| Design | An external hex threaded root-form implant to be used<br>with mating abutments having an integral anti-rotation<br>feature. | An external hex threaded root-form implant to be used<br>with mating abutments having an integral anti-rotation<br>feature. |
| Reusable | No | No |
| Dimensions | Implant Ø: 3.5, 4.3 and 5.0 mm<br>Length: 18 mm<br>Platform Ø: 3.5, 3.9 and 5.0 mm | Implant Ø: 3.5, 4.3 and 5.0 mm<br>Length: 18 mm<br>Platform Ø: 3.5, 3.9 and 5.0 mm |
| Material | Commercially pure titanium, grade 4 | Commercially pure titanium, grade 4 |
| Sterilization<br>Method | Gamma irradiation, 25 kGy min. | Gamma irradiation, 25 kGy min. |
| Shelf Life | 4 years | 2 years |

| Table 2. Comparative table between subject implants and previously cleared implants per K150182 | | | |
|-------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | |
| | Neodent Implant System - Change in the Shelf Life for<br>Neodent Acqua Implants<br>JJGC Indústria e Comércio de Materiais Dentários S.A. | K150199<br>Neodent Implant System<br>JJGC Indústria e Comércio de Materiais Dentários S.A. | |
| Indications for<br>Use | CM Alvim Acqua Implant | CM Alvim Acqua Implant | |
| | 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 unit<br>restorations, and may be loaded immediately when good<br>primary stability is achieved and with appropriate<br>occlusal loading. Multiple tooth applications may be<br>rigidly splinted. | 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 unit<br>restorations, and may be loaded immediately when good<br>primary stability is achieved and with appropriate<br>occlusal loading. Multiple tooth applications may be<br>rigidly splinted. | |
| | Facility Acqua Implant | Facility Acqua Implant | |
| | 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 unit<br>restorations, and may be loaded immediately when good<br>primary stability is achieved and with appropriate<br>occlusal loading. | 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 unit<br>restorations, and may be loaded immediately when good<br>primary stability is achieved and with appropriate<br>occlusal loading. | |
| | The Facility implant is indicated for replacement of<br>maxillary lateral incisors, mandibular incisors or retention<br>of overdentures. | The Facility implant is indicated for replacement of<br>maxillary lateral incisors, mandibular incisors or retention<br>of overdentures. | |
| | CM Anatomic Abutment, Exact Anatomic, Lateral<br>Anatomic, and Lateral Anatomic Abutments | CM Anatomic Abutment, Exact Anatomic, Lateral<br>Anatomic, and Lateral Anatomic Abutments | |
| | 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 unit<br>restorations, and may be loaded immediately when good<br>primary stability is achieved and with appropriate<br>occlusal loading. | 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 unit<br>restorations, and may be loaded immediately when good<br>primary stability is achieved and with appropriate<br>occlusal loading. | |
| Design | An indexed Morse taper threaded root-form implant to<br>be used with mating abutments. | An indexed Morse taper threaded root-form implant to<br>be used with mating abutments. | |
| Reusable | No | No | |
| Dimensions | Platform Ø: 3.5, 4.3, 5.0 mm | Platform Ø: 3.5, 4.3, 5.0 mm | |
| | Implant Ø: 3.5, 4.3, 5.0 mm | Implant Ø: 3.5, 4.3, 5.0 mm | |
| | Length: 8, 10, 11.5, 13, 16 mm | Length: 8, 10, 11.5, 13, 16 mm | |
| Material | Commercially pure titanium, grade 4 | Commercially pure titanium, grade 4 | |
| Sterilization<br>Method | Gamma irradiation, 25 kGy min. | Gamma irradiation, 25 kGy min. | |
| Shelf Life | 4 years | 2 years | |
| | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | |
| | Neodent Implant System - Change in the Shelf Life for<br>Neodent Acqua Implants<br>JJGC Indústria e Comércio de Materiais Dentários S.A. | K163194<br>Neodent Implant System - GM Line<br>JJGC Indústria e Comércio de Materiais Dentários S.A. | |
| Indications for<br>Use | Indications for Use for GM implants and conventional<br>abutments: | Indications for Use for GM implants and conventional<br>abutments: | |
| | 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 unit<br>restorations, and may be loaded immediately when good<br>primary stability is achieved and with appropriate<br>occlusal loading. | 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 unit<br>restorations, and may be loaded immediately when good<br>primary stability is achieved and with appropriate<br>occlusal loading. | |
| | Indications for Use for GM Titanium Base abutments: | Indications for Use for GM Titanium Base abutments: | |
| | Titanium Base Abutment is a titanium base placed onto<br>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 for<br>cement-retained single or multi-unit restorations, or<br>screw-retained single restorations. | Titanium Base Abutment is a titanium base placed onto<br>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 for<br>cement-retained single or multi-unit restorations, or<br>screw-retained single restorations. | |
| | All digitally designed copings and/or crowns for use with<br>the Neodent Titanium Base Abutment System are<br>intended to be sent to Straumann for manufacture at a<br>validated milling center. | All digitally designed copings and/or crowns for use with<br>the Neodent Titanium Base Abutment System are<br>intended to be sent to Straumann for manufacture at a<br>validated milling center. | |
| | Indications for Use for GM Pro Peek Abutments:<br>The Pro PEEK Abutments are indicated to be used on<br>Neodent implants to provide temporary support for<br>prosthesis structure for up to 6 months. They can be used<br>in one or two stage procedures and also immediate load<br>when there is good primary stability. | Indications for Use for GM Pro Peek Abutments:<br>The Pro PEEK Abutments are indicated to be used on<br>Neodent implants to provide temporary support for<br>prosthesis structure for up to 6 months. They can be used<br>in one or two stage procedures and also immediate load<br>when there is good primary stability. | |
| Design | The dental implants are threaded, self-tapping, root<br>form and present a Morse taper implant-to-abutment<br>interface with an internal hexagonal index exclusive to<br>the GM line. | The dental implants are threaded, self-tapping, root<br>form and present a Morse taper implant-to-abutment<br>interface with an internal hexagonal index exclusive to<br>the GM line. | |
| Reusable…