NUVO CF Implant System

K203309 · JJGC Indústria e Comércio de Materiais Dentários S.A. · DZE · Jul 6, 2021 · Dental

Device Facts

• Record ID: K203309
• Device Name: NUVO CF Implant System
• Applicant: JJGC Indústria e Comércio de Materiais Dentários S.A.
• Product Code: DZE · Dental
• Decision Date: Jul 6, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

The NUVO CF Implant System consists of endosseous dental implants and various abutments (traditional, attachment, temporary, titanium base, and customized CARES abutments). Implants are surgically placed in the maxilla or mandible by dental professionals to support prosthetic restorations. The system uses an internal hexagonal interface for implant-to-abutment connection. Implants are bone-level, apically tapered, and feature a sand-blasted, acid-etched surface. Abutments are screw-retained to the implant and support either cement-retained or screw-retained prosthetics. The device is used in clinical dental settings. Healthcare providers use the system to restore chewing function and aesthetics for patients with missing teeth. The system includes components for both temporary healing phases and final prosthetic support. Benefits include stable prosthetic support and restoration of oral function.

Clinical Evidence

Bench testing only. No clinical data provided. Performance was validated via dynamic fatigue testing per ISO 14801, biocompatibility assessment per ISO 10993-1, sterilization validation (ISO 11137/11135), and bacterial endotoxin testing per ANSI/AAMI ST72:2011.

Technological Characteristics

Materials: Commercially pure titanium (ASTM F67), titanium alloy (ASTM F136), CoCr alloy (ASTM F1537), and POM polymer. Design: Bone-level, internal hex interface, apically tapered thread-form. Sterilization: Gamma irradiation (implants) or ethylene oxide (abutments) to SAL 10^-6. Connectivity: None (mechanical system).

Indications for Use

Indicated for patients requiring dental implants in the maxilla or mandible to support prosthetic devices (artificial teeth) for chewing function restoration. Applicable for single or multiple unit restorations, single or two-stage surgical procedures, and immediate loading when primary stability is achieved. Contraindications include patients where adequate primary stability cannot be achieved or where occlusal loading is inappropriate.

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

• NUVO IF Implant System (K193234)

Reference Devices

• Straumann® BLX Implant System (K173961)
• MRI Compatibility for Existing Neodent Implant System (K182620)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 06, 2021

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

Re: K203309

Trade/Device Name: NUVO CF Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: June 5, 2021 Received: June 7, 2021

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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

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

Sincerely.

for Andrew Steen Assistant 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}------------------------------------------------

# Indications for Use

510(k) Number (if known) K203309

Device Name NUVO CF Implant System

Indications for Use (Describe) Indications for Use for NUVO CF Implants:

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

Indications for Use for NUVO CF Traditional Abutments:

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

Indications for Use for Attachment Equator CF:

The Attachment Equator CF is intended to be surgically placed in the maxilla or mandible to provide support for prosthetic devices such as artificial teeth in order to restore chewing function. It may be used with singlestage or twostage procedures, for multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly splinted. The Attachment Equator abutments are indicated for the attachment of full or partial dentures to NUVO implants.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: overline;"> </span> 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

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

# Indications for Use

510(k) Number (if known) K203309

Device Name NUVO CF Implant System

| Indications for Use (Describe) | |
|-------------------------------------------------------------|--|
| Indications for Use for Attachment Removable Prosthesis CF: | |

The Attachment Removable Prosthesis CF is intended to be surgically placed in the maxilla or mandible to provide support for prosthetic devices such as artificial teeth in order to restore chewing function. It may be used with singlestage or two-stage procedures, for multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly splinted. The Attachment Removable Prosthesis abutments are indicated for the attachment of full or partial dentures to Nuvo implants.

Indications for Use for Temporary Abutments CF for Crown and for Bridge:

The Implant System is intended to be surgically placed in the maxilla or mandible to provide support for prosthetic devices such as artificial teeth in order to restore chewing function. It may be used with singlestage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly splinted. The Titanium Temporary Abutment is indicated to provide temporary support for prosthesis structure for up to 6 months.

Indications for Use for CF Titanium Base for Crown:

CF Titanium Base for Crown is a titanium abutment placed onto dental implants to provide support for customized prosthetic restorations, as copings or crowns. It is indicated for single-unit restorations, cement-retained in aesthetic areas on implants installa 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) | |
|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| <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

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

# Indications for Use

510(k) Number (if known) K203309

Device Name NUVO CF Implant System

| Indications for Use (Describe) | |
|------------------------------------------------------|--|
| Indications for Use for CF Titanium Base for Bridge: | |

CF Titanium Base for Bridge is a titanium abutment placed onto dental implants to provide support for customized prosthetic restorations. The CF Titanium Base for Bridge is indicated for cement or screw-retamed multi-unit restorations. All digitally designed copings and/or crowns to be used with the Titanium Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.

Indications for Use for Cares Abutment CF:

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

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

| | <span style="padding-right: 5px;"> </span> Prescription Use (Part 21 CFR 801 Subpart D) |
|--|-----------------------------------------------------------------------------------------|
| | <span style="padding-right: 5px;"></span> 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

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

#### K203309

#### ADMINISTRATIVE INFORMATION

| Sponsor | JJGC Indústria e Comércio de Materiais Dentários SA<br>(dba Neodent)<br>Av. Juscelino Kubitschek de Oliveira, 3291<br>Curitiba, Parana, Brazil 81270-200<br>Registration No.: 3008261720<br>Owner/Operator No.: 10031702 |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Jennifer M. Jackson, MS<br>Director of Regulatory Affairs,<br>Straumann USA<br>E-mail: [e-mail]<br>Telephone [phone] |
| Date Prepared | 06/07/2021 |
| Preparer / Alternate Contact | Mariana Soares Hartmann<br>Regulatory Affairs Analyst<br>JJGC Indústria e Comércio de Materiais Dentários SA<br>E-mail: [e-mail] |

#### DEVICE NAME AND CLASSIFICATION

| Trade/ Proprietary Name | NUVO CF Implant System |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name | Endosseous dental implant |
| | Endosseous dental implant abutment |
| Classification Name | Implant, Endosseous, Root-form |
| | Endosseous dental implant abutment |
| Classification Regulations | 21 CFR 872.3640, Class II |
| | 21 CFR 872.3630, Class II |
| Product Code | Primary: DZE |
| | Secondary: NHA |
| Classification Panel | Dental Products Panel |
| Reviewing Branch | Dental Devices Branch |
| PREDICATE DEVICE INFORMATION | |
| Primary Predicate Device | K193234 – NUVO IF Implant System, JJGC Indústria e Comércio de Materiais<br>Dentários SA |
| Reference Predicate Device | K173961 - Straumann® BLX Implant System, Institut Straumann AG<br>K182620 - MRI Compatibility for Existing Neodent Implant System, JJGC<br>Indústria e Comércio de Materiais Dentários S.A |

#### INDICATIONS FOR USE

#### Indications for Use for NUVO CF Implants:

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

#### Indications for Use for NUVO CF Traditional Abutments:

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

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

## Indications for Use for Attachment Equator CF:

The Implant System is intended to be surgically placed in the maxilla or mandible to provide support for prosthetic devices such as artificial teeth in order to restore chewing function. It may be used with singlestage or twostage procedures, for multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly splinted. The Attachment Equator abutments are indicated for the attachment of full or partial dentures to NUVO implants.

# Indications for Use for Attachment Removable Prosthesis CF:

The Implant System is intended to be surgically placed in the maxilla or mandible to provide support for prosthetic devices such as artificial teeth in order to restore chewing function. It may be used with singlestage or twostage procedures, for multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly splinted. The Attachment Removable Prosthesis abutments are indicated for the attachment of full or partial dentures to Nuvo implants.

# Indications for Use for Temporary Abutments CF for Crown and for Bridge:

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

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

# Indications for Use for CF Titanium Base for Crown:

CF Titanium Base for Crown is a titanium abutment placed onto dental implants to provide support for customized prosthetic restorations, as copings or crowns. It is indicated for single-unit restorations, cement-retained or screwretained in aesthetic areas on implants installed in 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.

# Indications for Use for CF Titanium Base for Bridge:

CF Titanium Base for Bridge is a titanium abutment placed onto dental implants to provide support for customized prosthetic restorations. The CF Titanium Base for Bridge is indicated for cement or screw-retained multi-unit restorations. All digitally designed copings and/or crowns to be used with the Titanium Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.

# Indications for Use for Cares Abutment CF:

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

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

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

#### SUBJECT DEVICE DESCRIPTIONS

#### Implants

- Intended for single use;
- Provided sterile via gamma irradiation
- Manufactured of commercially pure titanium (Grade 4) per ASTM F67; ●
- Bone level design
- Apically tapered thread-form with apical cutting flutes in 3.5 and 3.75 mm diameters with lengths of 8, 10, 11.5, 13, 16 & 18 mm, 4.0 and 4.3 mm diameters with lengths of 7, 8, 10, 11.5, 13, 16 & 18 mm and in 5.0 mm diameter with lengths of 7, 8, 10, 11.5, 13 & 16 mm.
- Provided with an internal hexagonal implant-to-abutment interface compatible with the subject Cover Screw and Abutments.

## Cover Screws

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

## Abutments

- Intended for single use;
- All the abutments are provided sterile via ethylene oxide gas, with exemption of the Cobalt-Chromium UCLA CF and the CARES Abutment CF, which are delivered non-sterile. Both products must be sterilized before use, as indicated in their IFU.
- Manufactured of titanium alloy (Ti6Al4V-ELI) per ASTM F136 or in a combination of POM (Polyoxymethylene) polymer and cobalt-chromium alloy (CoCr), conforming to ASTM F1537;
- Conical format available in different diameters, height of cementable area and gingival height;
- Screw-retained to the implant;
- Provided with an implant-to-abutment interface compatible with the internal hexagonal geometry of the subject Nuvo CF implants;
- Provided with coronal geometries in rotational (non-indexed) versions to support multi-unit restorations and in anti-rotational (indexed) versions to support single restorations

## SUBSTANTIAL EQUIVALENCE COMPARISON TABLES

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

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

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

| | SUBJECT DEVICES | PRIMARY PREDICATE |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| COMPARISON | K203309 | K193234 |
| | NUVO CF Implant System | NUVO IF Implant System |
| | JJGC Indústria e Comércio de Materiais Dentários S.A. | JJGC Indústria e Comércio de Materiais Dentários S.A. |
| Indications for Use<br>Statement | Indications for Use for NUVO CF Implants | Indications for Use for NUVO IF Implants and conventional abutments: |
| | The Implant System is intended to be surgically placed in the maxilla or mandible to provide support for | The NUVO IF Implant System is intended to be surgically placed in the maxilla or mandible to provide support |
| | prosthetic devices such as artificial teeth in order to restore chewing function. It may be used with single-stage | for prosthetic devices such as artificial teeth in order to restore chewing function. It may be used with single- |
| | or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good<br>primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly | stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when<br>good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be |
| | splinted. | rigidly splinted. |
| | Indications for Use for NUVO CF Traditional Abutments: | The Titanium Temporary Abutment is indicated to provide temporary support for prosthesis structure for |
| | The Implant System is intended to be surgically placed in the maxilla or mandible to provide support for | up to 6 months. |
| | prosthetic devices such as artificial teeth in order to restore chewing function. It may be used with single-stage | |
| | or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good | The Attachment Equator and Attachment Removable Prosthesis abutments are indicated for the attachment |
| | primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly | of full or partial dentures to NUVO implants. |
| | splinted. | |
| | Indications for Use for Attachment Equator CF: | Indications for Use for Rotational and Anti-rotational Titanium Bases abutments: |
| | The Attachment Equator is intended to be surgically placed in the maxilla or mandible to provide support for | Titanium Base Abutment is a titanium base placed onto dental implants to provide support for customized |
| | prosthetic devices such as artificial teeth in order to restore chewing function. It may be used with single-stage | prosthetic restorations. It is used with a coping and crown, or crown alone, and is indicated for cement-<br>retained single or multi-unit restorations or screw-retained single restorations. |
| | or two-stage procedures, for multiple unit restorations, and may be loaded immediately when good primary | All digitally designed copings and/or crowns to be used with the Titanium Base Abutment System are |
| | stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly splinted | intended to be sent to Straumann for manufacture at a validated milling center. |
| | The Attachment Equator abutments are indicated for the attachment of full or partial dentures to NUVO | The Rotational Titanium Base is indicated for cement or screw-retained multi-unit restorations. |
| | implants. | |
| | | Indications for Use for CARES® Abutment IF: |
| | Indications for Use for Attachment Removible Prosthesis CF:<br>The Attachment Removable Prosthesis is intended to be surgically placed in the maxilla or mandible to provide | The CARES® Abutment is a customized prosthetic abutment, manufactured in titanium alloy, placed onto |
| | support for prosthetic devices such as artificial teeth in order to restore chewing function. It may be used with | dental implants to provide support for customized prosthetic restorations (copings or crowns). It is indicated |
| | single-stage or two-stage procedures, for multiple unit restorations, and may be loaded immediately when | for screw-retained or cement-retained single restorations. |
| | good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be | All digitally designed abutments for use with the CARES® Abutment are intended to be sent to Straumann |
| | rigidly splinted. The Attachment Removable Prosthesis abutments are indicated for the attachment of full or | for manufacturing at a validated milling center. |
| | partial dentures to NUVO implants. | |
| | Indications for Use for Temporary Abutment CF for Crown and for Bridge: | |
| | The Implant System is intended to be surgically placed in the maxilla or mandible to provide support for | |
| | prosthetic devices such as artificial teeth in order to restore chewing function. It may be used with single-stage | |
| | or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good | |
| | primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly | |
| | splinted. The Titanium Temporary Abutment is indicated to provide temporary support for prosthesis structure | |
| | for up to 6 months. | |
| | | |
| | Indications for Use for Titanium Bases for Crown:<br>Titanium Base for Crown is a titanium abutment placed onto dental implants to provide support for customized | |
| | prosthetic restorations, as copings or crowns. It is indicated for single-unit restorations, cement-retained or | |
| | screw-retained in aesthetic areas on implants installed in 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…