NUVO CF Implant System

• K Number: K203309
• Device Name: NUVO CF Implant System
• Manufacturer: JJGC Indústria e Comércio de Materiais Dentários SA
• Date Cleared: 2021-07-06 ( 238 days)
• Product Code: DZE NHA
• Regulation Number: 872.3640

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. The Attachment Equator abutments are indicated for the attachment of full or partial dentures to NUVO implants. The Attachment Removable Prosthesis abutments are indicated for the attachment of full or partial dentures to Nuvo implants. The Titanium Temporary Abutment is indicated to provide temporary support for prosthesis structure for up to 6 months. 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. 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. 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-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.

Device Description

The NUVO CF Implant System includes Implants, Cover Screws, and Abutments. Implants are intended for single use, provided sterile via gamma irradiation, manufactured of commercially pure titanium (Grade 4), have a bone level design, apically tapered thread-form with apical cutting flutes, and an internal hexagonal implant-to-abutment interface. Cover Screws are intended for single use, used to protect the internal geometry of the implants during healing, placed out of occlusion, provided sterile via gamma irradiation or ethylene oxide gas, manufactured of titanium alloy (Ti6Al4V-ELI), and have an implant-to-abutment interface compatible with the internal hexagonal geometry of the implants. Abutments are intended for single use, provided sterile via ethylene oxide gas (except Cobalt-Chromium UCLA CF and CARES Abutment CF which are non-sterile and must be sterilized before use), manufactured of titanium alloy (Ti6Al4V-ELI) or a combination of POM polymer and cobalt-chromium alloy (CoCr), have a conical format in different diameters, height of cementable area and gingival height, are screw-retained to the implant, provided with an implant-to-abutment interface compatible with the internal hexagonal geometry of the implants, and provided with coronal geometries in rotational (non-indexed) and anti-rotational (indexed) versions.

Predicate Devices

K193234

Reference Devices

K173961, K182620

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a dental implant system and its components. There is no mention of AI, ML, image processing, or any data-driven algorithms in the intended use, device description, or performance studies. The focus is on the physical properties, materials, and mechanical performance of the implants and abutments.

Therapeutic

Yes
The device, an Implant System, is surgically placed to support prosthetic devices to restore chewing function, which is a therapeutic purpose.

Diagnostic

No

This device, the NUVO CF Implant System, is intended for surgical placement in the maxilla or mandible to provide support for prosthetic devices (like artificial teeth) to restore chewing function. It is a therapy/treatment device, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description explicitly details physical components such as implants, cover screws, and abutments made of titanium and other materials, which are surgically implanted. This is not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly describes a surgical implant system for supporting prosthetic devices in the mouth to restore chewing function. This is a therapeutic and restorative purpose, not a diagnostic one.
• Device Description: The device components (implants, cover screws, abutments) are all physical structures designed for surgical implantation and mechanical support. They do not involve the examination of specimens derived from the human body for diagnostic purposes.
• Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
  • Analyzing biological samples (blood, urine, tissue, etc.)
  • Detecting or measuring substances in biological samples
  • Providing information for the diagnosis, monitoring, or prognosis of a disease or condition
  • Using reagents or calibrators

The device is a medical device, specifically a dental implant system, but it falls under the category of surgical and prosthetic devices, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

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.

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.

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.

Product codes (comma separated list FDA assigned to the subject device)

DZE, NHA

Device Description

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

maxilla or mandible

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Bench testing: Dynamic fatigue test per ISO 14801 and FDA guidance was performed to determine the fatigue strength for the worst-case constructs assembled using the subject devices.
MRI compatibility testing: MRI compatibility testing was leveraged from the reference device K182620.
Sterilization validation: Sterilization of the subject endosseous dental implant devices via gamma irradiation was validated per ISO 11137-1 and ISO 11137-2. A minimum Sterility Assurance Level (SAL) of 1 x 10th has been validated. Sterilization of the subject abutments via ethylene oxide gas was validated per ISO 11135. A minimum Sterility Assurance Level (SAL) of 1 x 10-6 has been validated.
Biocompatibility: Biological Safety Assessment for the subject devices was guided by ISO 10993-1 and FDA guidance. Biocompatibility for the subject devices was leveraged from the primary predicate K193234 and reference predicate K173961.
Package transport integrity testing: ISTA 2A.
Product and package stability: ASTM F1980.
Ethylene oxide residuals: Assessed per ISO 10993-7. Residuals are within accepted limits.
Bacterial Endotoxin Testing: Performed on representative samples selected and tested based upon the raw material, manufacturing processes and sterilization process, according to ANSI/AAMI ST72:2011, Bacterial Endotoxins – Test Methods, Routine Monitoring and Alternatives to Batch Testing. The obtained results were

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
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.(b)
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.

Summary

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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

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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)
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.

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*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)
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

"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)

	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

"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
(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 | 06/07/2021 |
| Preparer / Alternate Contact | Mariana Soares Hartmann
Regulatory Affairs Analyst
JJGC Indústria e Comércio de Materiais Dentários SA
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
Dentários SA
Reference Predicate Device	K173961 - Straumann® BLX Implant System, Institut Straumann AG
K182620 - MRI Compatibility for Existing Neodent Implant System, JJGC
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
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
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
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-
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:
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:
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
	manufacture at a validated milling center.
	SUBJECT DEVICES	PRIMARY PREDICATE
COMPARISON	K203309
NUVO CF Implant System
JJGC Indústria e Comércio de Materiais Dentários S.A.

Indications for Use for Titanium Base for Bridge:
CF Titanium Base for Bridge is a titanium abutment placed onto dental implants to provide support for
customized prosthetic restorations. It 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 screw-retained 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. | K193234
NUVO IF Implant System
JJGC Indústria e Comércio de Materiais Dentários S.A. |

9

10

The scope of the Indications for Use Statement for the subject devices (Implants and Conventional Abutments) are equivalent to the corresponding section of the Indications for Use Statement of the primary predicate device K193234, only with greater separation between product categories. The main language difference is in the indication for use of the Attachment Equator and Attachment Removable Prosthesis, since the indication presented to these devices are specific to the products, and therefore recommended for multiple restorations only. The indication for use presented to the predicate devices is applicable for all the implant system, and therefore recommended for both types of restorations. However, the subject devices are covered by the predicate devices since the predicate indication for use is more comprehensive.

The Indications for Use Statement for the subject device (Titanium Base for Crown and Titanium Base for Bridge abutments) are equivalent to the corresponding section of the Indications for Use Statement of K193234, except for the names of the devices and the greater separation between product categories. The language difference between the indications for use occurs again due to the indication applied to the reference devices being more comprehensive, for both types of bases. While for the subject devices the indication is presented separately and specific for each type of base in the Indications for Use Statement form.

The indication for use for the subject device (CF CARES® ABUTMENT) was not initially included in the Indications for Use Statement and is being added in this review.

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

11

	SUBJECT DEVICES	PRIMARY PREDICATE
COMPARISON	Subject	K193234	EQUIVALENCE DISCUSSION
	NUVO CF Implant System
JJGC Indústria e Comércio de Materiais Dentários S.A.	NUVO IF Implant System
JJGC Indústria e Comércio de Materiais Dentários S.A.
Implant Type	Bone Level	Bone Level	Identical
The subject devices have the same external design as the primary predicate.
Implant-to-Abutment
Interface	Internal Hex	Internal Hex	Equivalent
The implant interface is equivalent to that of the primary predicate device.
Implant Diameter	3.5 mm, 3.75 mm, 4.0, 4.3 mm and 5.0 mm	3.5 mm, 3.75 mm, 4.3 mm and 5.0 mm	Equivalent
The subject device diameters are in the range of diameters of the primary predicate devices.
Implant Length	3.5 mm: 8, 10, 11.5, 13, 16 & 18 mm
3.75 mm: 8, 10, 11.5, 13, 16 & 18 mm
4.0 mm: 7, 8, 10, 11.5, 13, 16 & 18 mm
4.3 mm: 7, 8, 10, 11.5, 13, 16 & 18 mm
5.0 mm: 7, 8, 10, 11.5, 13 & 16 mm	3.5 mm: 7, 10, 11.5, 13, 16 & 18 mm
3.75 mm: 7, 10, 11.5, 13, 16 & 18 mm
4.3 mm: 7, 10, 11.5, 13, 16 & 18 mm
5.0 mm: 7, 10, 11.5, 13 & 16 mm	Equivalent
The subject device lengths are within the range established by the primary predicate devices.
Thread Design	Apically Tapered, Dual Helix	Apically Tapered, Dual Helix	Identical
The subject devices have the same thread design as the primary predicate.
Surface Finish	Sand blasted and acid etched	Sand blasted and acid etched	Identical
Subject and primary predicate devices have the same surface finish
Material	Commercially Pure Titanium (Grade 4)	Commercially Pure Titanium (Grade 4)	Identical
Subject and primary predicate devices have the same material of construction.
Single Use	Yes	Yes	Identical
Subject and predicate devices are not reusable.
Sterilization Method	Gamma Irradiation to an SAL of 1x10-6	Gamma Irradiation to an SAL of 1x10-6	Identical
Subject and primary predicate devices utilize the same sterilization method and minimum SAL

Table 2: Substantial Equivalence Comparison – Implants

12

COMPARISON	SUBJECT DEVICES	PRIMARY PREDICATE	EQUIVALENCE DISCUSSION
	Subject	K193234
	NUVO CF Implant System
JJGC Indústria e Comércio de Materiais Dentários S.A.	NUVO IF Implant System
JJGC Indústria e Comércio de Materiais Dentários S.A.
Implant-to-Abutment
Interface	Internal Hex	Internal Hex	Equivalent
The implant interface is equivalent
to that of the primary predicate
device.
Single Use	Yes	Yes	Identical
Subject and predicate devices are
not reusable.
Abutment Design	Screw used to protect internal features of the implant during
submerged healing protocol.
Apical Geometry = Internal Hex
Material = Titanium Alloy (Ti-6Al-4V)	Screw used to protect internal features of the implant during
submerged healing protocol.
Apical Geometry = Internal Hex
Material = Titanium Alloy (Ti-6Al-4V)	Equivalent
The subject devices and the
primary predicate devices share
similar apical geometry.
Sterilization Method	Ethylene Oxide to an SAL of 1x10-6	Ethylene Oxide to an SAL of 1x10-6	Identical
The subject devices and the primary
predicate devices share the same
sterilization method.
Surface Treatment	Machined and Electrolysis (only NP platform)	Machined and Electrolysis (only NP platform)	Identical
Subject and primary predicate devices
utilize the same surface treatment.

13

Table 4: Substantial Equivalence Comparison – Healing Abutment

	SUBJECT DEVICES	PRIMARY PREDICATE
	Subject	K193234
COMPARISON	NUVO CF Implant System
JJGC Indústria e Comércio de Materiais Dentários S.A.	NUVO IF Implant System
JJGC Indústria e Comércio de Materiais Dentários S.A.	EQUIVALENCE DISCUSSION
Implant-to-Abutment
Interface	Internal Hex	Internal Hex	Equivalent
The implant interface is equivalent
to that of the primary predicate
device.
Single Use	Yes	Yes	Identical
Subject and predicate devices are
not reusable.
Abutment Design	Screw having a coronal geometry to define gingiva shape during
delayed loading protocols.
Angulation: 0°
Coronal Geometry: Smooth emergence profile in multiple
heights to address different gingiva types
Apical Geometry: Internal Hex
Material = Titanium Alloy (Ti-6Al-4V)	Screw having a coronal geometry to define gingiva shape during
delayed loading protocols.
Angulation: 0°
Coronal Geometry: Smooth emergence profile in multiple
heights to address different gingiva types
Apical Geometry: Internal Hex
Material = Titanium Alloy (Ti-6Al-4V)	Equivalent
The subject devices and the
primary predicate devices share
similar coronal and apical
geometry.
Sterilization Method	Ethylene Oxide to an SAL of 1x10-6	Ethylene Oxide to an SAL of 1x10-6	Identical
The subject devices and the primary
predicate devices share the same
sterilization method.
Surface Treatment	Machined and Electrolysis (only NP platform)	Machined and Electrolysis (only NP platform)	Identical
Subject and primary predicate devices
utilize the same surface treatment.

14

	SUBJECT DEVICES	PRIMARY PREDICATE
COMPARISON	Subject	K193234	EQUIVALENCE DISCUSSION
	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.
Implant-to-Abutment
Interface	Internal Hex	Internal Hex	Equivalent
The implant interface is equivalent
to that of the primary predicate
device.
Single Use	Yes	Yes	Identical
Subject and predicate devices are
not reusable.
Abutment Design	Abutment designed to accept a cement-retained prosthetic.
Angulation:
0°, 17° & 25°
Coronal Geometry: Generally conical shape
Gingival Height: NP – 1, 2, 3, 4 & 5 mm
SP – 1, 2, 3, 4 & 5 mm
Apical Geometry: Internal Hex
Indexing: Both indexed and non-indexed
Material: Titanium Alloy (Ti-6Al-4V)	Abutment designed to accept a cement-retained prosthetic.
Angulation:
0°, 17° & 25°
Coronal Geometry: Generally conical shape
Gingival Height: NP – 0.5, 1, 2 & 3 mm
SP – 0.5, 1, 2 & 3 mm
Apical Geometry: Internal Hex
Indexing: Both indexed and non-indexed
Material: Titanium Alloy (Ti-6Al-4V)	Equivalent
The subject devices and the
primary predicate devices share
similar coronal and apical
geometry.
Worst-case angulation equivalent
to primary predicate devices.
Surface treatment	NP platform: Electrolysis
SP Platform: Machined	NP platform: Electrolysis
SP Platform: Machined	Identical
Both subject and predicate devices
present the same surface treatment
Sterilization Method	Ethylene Oxide to an SAL of 1x10-6	Ethylene Oxide to an SAL of 1x10-6	Identical
The subject devices and the primary
predicate devices share the same
sterilization method.
Surface Treatment	Machined and Electrolysis (only NP platform)	Machined and Electrolysis (only NP platform)	Identical
Subject and primary predicate devices
utilize the same surface treatment.

Table 5: Substantial Equivalence Comparison – Cement Retained Abutment CF

15

	SUBJECT DEVICES	PRIMARY PREDICATE
COMPARISON	Subject
NUVO CF Implant System
JJGC Indústria e Comércio de Materiais Dentários S.A.	K193234
NUVO IF Implant System
JJGC Indústria e Comércio de Materiais Dentários S.A.	EQUIVALENCE DISCUSSION
Implant-to-Abutment
Interface	Internal Hex	Internal Hex	Equivalent
The implant interface is equivalent
to that of the primary predicate
device.
Single Use	Yes	Yes	Identical
Subject and predicate devices are
not reusable.
Abutment Design	Abutment designed to accept a screw-retained prosthetic.
Angulation:
0°, 17° & 30°
Coronal Geometry: Generally conical shape
Gingival Height:
NP – 1, 2, 2.5, 3, 3.5, 4 & 5 mm
SP – 1, 2, 2.5, 3, 3.5, 4 & 5 mm
Apical Geometry:
Internal Hex
Indexing:
indexed (angled abutments) and non-
indexed (straight abutments)
Material:
Titanium Alloy (Ti-6Al-4V)	Abutment designed to accept a screw-retained prosthetic.
Angulation:
0°, 17° & 30°
Coronal Geometry: Generally conical shape
Gingival Height:
NP – 0.5, 1, 2, 2.3, 3, 4 & 5 mm
SP – 1, 2, 2.3, 3, 4 & 5 mm
Apical Geometry:
Internal Hex
Indexing:
indexed (angled abutments) and non-
indexed (straight abutments)
Material:
Titanium Alloy (Ti-6Al-4V)	Equivalent
The subject devices and the
primary predicate devices share
similar coronal and apical
geometry.
Surface treatment	NP platform: Electrolysis
SP Platform: Machined	NP platform: Electrolysis
SP Platform: Machined	Identical
Both subject and predicate devices
present the same surface
treatment
Sterilization Method	Ethylene Oxide to an SAL of 1x10-6	Ethylene Oxide to an SAL of 1x10-6	Identical
The subject devices and the primary
predicate devices share the same
sterilization method.
Surface Treatment	Machined and Electrolysis (only NP platform)	Machined and Electrolysis (only NP platform)	Identical
Subject and primary predicate devices
utilize the same surface treatment.

Table 6: Substantial Equivalence Comparison – Multi-Unit Screw Retained Abutment CF

16

COMPARISON	SUBJECT DEVICES	PRIMARY PREDICATE	EQUIVALENCE DISCUSSION
	Subject	K193234
	NUVO CF Implant System
JJGC Indústria e Comércio de Materiais Dentários S.A.	NUVO IF Implant System
JJGC Indústria e Comércio de Materiais Dentários S.A.
Implant-to-Abutment Interface	Internal Hex	Internal Hex	Equivalent
The implant interface is equivalent to that of the primary predicate device.
Single Use	Yes	Yes	Identical
Subject and predicate devices are not reusable.
Abutment Design	Abutment to accept detachable over-denture prostheses.
Angulation: 0°
Coronal Geometry: To accept o-ring style matrices
Gingival Height: NP – 1, 2, 3, 4 & 5 mm
SP – 1, 2, 3, 4 & 5 mm
Apical Geometry: Internal Hex
Indexing: Non-indexed
Material: Titanium Alloy (Ti-6Al-4V)	Abutment to accept detachable over-denture prostheses.
Angulation: 0°
Coronal Geometry: To accept o-ring style matrices
Gingival Height: NP – 1, 2, 3, 4 & 5 mm
SP – 1, 2, 3, 4 & 5 mm
Apical Geometry: Internal Hex
Indexing: Non-indexed
Material: Titanium Alloy (Ti-6Al-4V)	Equivalent
The subject devices and the primary predicate devices share similar coronal and apical geometry.
Surface treatment	NP platform: Electrolysis
SP Platform: Machined	NP platform: Electrolysis
SP Platform: Machined	Identical
Both subject and predicate devices present the same surface treatment
Sterilization Method	Ethylene Oxide to an SAL of 1x10-6	Ethylene Oxide to an SAL of 1x10-6	Identical
The subject devices and the primary predicate devices share the same sterilization method.
Surface Treatment	Machined with titanium nitride (TiN) coating	Machined with titanium nitride (TiN) coating	Identical
Subject and primary predicate devices utilize the same surface treatment

Table 7: Substantial Equivalence Comparison – Attachment Equator CF

17

Table 8: Substantial Equivalence Comparison – Attachment Removable Prosthesis CF

	SUBJECT DEVICES	PRIMARY PREDICATE
COMPARISON	Subject	K193234	EQUIVALENCE DISCUSSION
	NUVO CF Implant System
JJGC Indústria e Comércio de Materiais Dentários S.A.	NUVO IF Implant System
JJGC Indústria e Comércio de Materiais Dentários S.A.
Implant-to-Abutment Interface	Internal Hex	Internal Hex	Equivalent
The implant interface is equivalent
to that of the primary predicate
device.
Single Use	Yes	Yes	Identical
Subject and predicate devices are
not reusable.
Abutment Design	Abutment to accept detachable over-denture prostheses.
Angulation: 0°
Coronal Geometry: To accept Valoc Novaloc matrices
Gingival Height: NP – 1, 2, 3, 4 & 5 mm
SP – 1, 2, 3, 4 & 5 mm
Apical Geometry: Internal Hex
Indexing: Non-indexed
Material: Titanium Alloy (Ti-6Al-4V)	Abutment to accept detachable over-denture prostheses.
Angulation: 0°
Coronal Geometry: To accept Valoc Novaloc matrices
Gingival Height: NP – 1, 2, 3, 4 & 5 mm
SP – 1, 2, 3, 4 & 5 mm
Apical Geometry: Internal Hex
Indexing: Non-indexed
Material: Titanium Alloy (Ti-6Al-4V)	Equivalent
The subject devices and the
primary predicate devices share
similar coronal and apical
geometry.
Surface treatment	NP platform: Electrolysis
SP Platform: Machined	NP platform: Electrolysis
SP Platform: Machined	Identical
Both subject and predicate devices
present the same surface
treatment
Sterilization Method	Ethylene Oxide to an SAL of 1x10-6	Ethylene Oxide to an SAL of 1x10-6	Identical
The subject devices and the primary
predicate devices share the same
sterilization method.
Surface Treatment	Machined with titanium nitride (TiN) coating	Machined with titanium nitride (TiN) coating	Identical
Subject and primary predicate devices
utilize the same surface treatment.

18

Table 9: Substantial Equivalence Comparison – Cobalt-Chromium UCLA CF

COMPARISON	SUBJECT DEVICES	PRIMARY PREDICATE	EQUIVALENCE DISCUSSION
	Subject	K193234
	NUVO CF Implant System
JJGC Indústria e Comércio de Materiais Dentários S.A.	NUVO IF Implant System
JJGC Indústria e Comércio de Materiais Dentários S.A.
Implant-to-Abutment
Interface	Internal Hex	Internal Hex	Equivalent
The implant interface is equivalent
to that of the primary predicate
device.
Single Use	Yes	Yes	Identical
Subject and predicate devices are
not reusable.
Abutment Design	Abutment to facilitate the casting of base metal and precious
metal alloy prostheses.
Angulation: 0°
Coronal Geometry: Generally cylindrical
Gingival Height: 1 mm
Apical Geometry: Internal Hex
Indexing: Both indexed and non-indexed
Material: CoCr Alloy with POM polymer	Abutment to facilitate the casting of base metal and precious
metal alloy prostheses.
Angulation: 0°
Coronal Geometry: Generally cylindrical
Gingival Height: 1 mm
Apical Geometry: Internal Hex
Indexing: Both indexed and non-indexed
Material: CoCr Alloy with POM polymer	Equivalent
The subject devices share the same
coronal and apical geometry as the
primary predicate device.
Sterilization Method	Provided non-sterile. Terminally sterilized by the user via moist heat.
Moist heat cycle parameters have been validated to an SAL of 1 x 106.	Provided non-sterile. Terminally sterilized by the user via moist heat.
Moist heat cycle parameters have been validated to an SAL of 1 x 106.	Identical
The subject devices and the
primary predicate devices share
the same sterilization method.
Surface Treatment	Machined and Electrolysis (only NP platform)	Machined and Electrolysis (only NP platform)	Identical
Subject and primary predicate devices
utilize the same surface treatment.

19

	SUBJECT DEVICES	PRIMARY PREDICATE
COMPARISON	Subject	K193234	EQUIVALENCE DISCUSSION
	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.
Implant-to-Abutment Interface	Internal Hex	Internal Hex	Equivalent
The implant interface is equivalent
to that of the primary predicate
device.
Single Use	Yes	Yes	Identical
Subject and predicate devices are
not reusable.
Abutment Design	Abutment for the creation of a temporary, non-occlusal
restoration to address esthetics during fabrication of final
prosthesis.	Abutment for the creation of a temporary, non-occlusal
restoration to address esthetics during fabrication of final
prosthesis.	Equivalent
The subject devices and the
primary predicate devices share
similar coronal and apical
geometries.
	Angulation: 0°	Angulation: 0°
	Coronal Geometry: Generally cylindrical with
grooves to bond acrylic resins	Coronal Geometry: Generally cylindrical with
grooves to bond acrylic resins
	Gingival Height: 1 mm	Gingival Height: 1 mm
	Apical Geometry: Internal Hex	Apical Geometry: Internal Hex
	Indexing: Both indexed and non-indexed	Indexing: Both indexed and non-indexed
	Material: Titanium Alloy (Ti-6Al-4V)	Material: Titanium Alloy (Ti-6Al-4V)
Sterilization Method	• Ethylene Oxide to an SAL of 1x10-6	• Ethylene Oxide to an SAL of 1x10-6	Identical
The subject devices and the primary
predicate devices share the same
sterilization method.
	• If customized on the chairside, must be sterilized before	• If customized on the chairside, must be sterilized before
	the installation via moist heat (steam), Gravity	the installation via moist heat (steam), Gravity
	displacement or dynamic air removal in 132°C (270°F) for	displacement or dynamic air removal in 132°C (270°F) for
	3 minute exposure.	3 minute exposure.
Surface Treatment	Machined (SP platform)	Machined (SP platform)	Identical
Subject and primary predicate devices
utilize the same surface treatment.
	Machined and Electrolysis (NP platform)	Machined and Electrolysis (NP platform)

20

		SUBJECT DEVICES		PRIMARY PREDICATE		REFERENCE PREDICATE
COMPARISON		Subject		K193234	K173961		EQUIVALENCE
DISCUSSION
		NUVO CF Implant System
JJGC Indústria e Comércio de Materiais Dentários S.A.		NUVO IF Implant System
JJGC Indústria e Comércio de Materiais Dentários S.A.	Straumann® BLX Implant System
Institut Straumann AG
Implant-to-
Abutment
Interface		Internal Hex		Internal Hex	Internal Hex		Equivalent
The implant interface is
equivalent to that of the
primary predicate
device.
Single Use		Yes		Yes	Yes		Identical
Subject and predicate
devices are not reusable
Abutment
Design		Abutment designed to accept a cement-retained
prosthetic.
Angulation: 0°
Coronal Geometry: Generally cylindrical shape
Platform Ø: NP - 3.5 & 4.5 mm
SP - 4.5 & 5.5 mm
Gingival Height: NP - 0.5, 1 & 3 mm
SP - 0.5, 1 & 3 mm
Apical Geometry: Internal Hex
Indexing: Indexed
Material: Titanium Alloy (Ti-6Al-4V)		Abutment designed to accept a cement-retained
prosthetic.
Angulation: 0°
Coronal Geometry: Generally cylindrical shape
Platform Ø: NP - 3.5 mm
SP - 4.5 & 5.5 mm
Gingival Height: NP - 0.5, 1 & 3 mm
SP - 0.5, 1 & 3 mm
Apical Geometry: Internal Hex
Indexing: Indexed
Material: Titanium Alloy (Ti-6Al-4V)	Abutment designed to accept a
cement-retained prosthetic.
Angulation: 0°
Coronal Geometry: Generally
cylindrical shape
Platform Ø: 3.8, 4.5, 5.5 mm
Gingival Height: 0.75 - 2.5 mm
Apical Geometry: Internal Hex
Indexing: Indexed
Material: Niobium Alloy (Ti-6Al-7Nb)		Equivalent
The subject devices and
the primary predicate
devices (K193234) share
similar coronal and apical
geometry. The subject
devices present
dimensions contained
within the range of
dimension of the
predicate devices
(K173961).
	CAD/CAM
Restoration
Angulation		Up to 30°		Up to 30°	Up to 30°		Identical
Subject and predicate
devices present the same
CAD/CAM Restoration
Angulation.

Table 11: Substantial Equivalence Comparison – CF Titanium Base for Crown (Antirotational)

21

| COMPARISON | SUBJECT DEVICES
Subject
NUVO CF Implant System
JJGC Indústria e Comércio de Materiais Dentários S.A. | | | PRIMARY PREDICATE
K193234
NUVO IF Implant System
JJGC Indústria e Comércio de Materiais Dentários S.A. | | | REFERENCE PREDICATE
K173961
Straumann® BLX Implant System
Institut Straumann AG | | | EQUIVALENCE DISCUSSION |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|------------------------------|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Top half
materials | Material | Minimum
thickness (mm) | Maximum
allowable
angulation | Material | Minimum
thickness
(mm) | Maximum
allowable
angulation | Material | Minimum
thickness
(mm) | Maximum
allowable
angulation | Equivalent
The subject top half
materials are contained
within the scope of the
cleared top half
materials for the
predicate devices and
using the same cleared
design parameters.
The subject Titanium
Base for Crown, when
combined with Polycon
ae restoration, can
remain in the mouth for
the same time indicated
in the reference
predicate devices
K173961. |
| | Coron (CoCr) | 0.3 | 30° | Coron (CoCr) | 0.3 | 30° | Polycon ae* | 0.5 | 30° | |
| | IPS e.max CAD | 0.9 | | Zirconia (Zerion LT) | 0.5 | | IPS
e.max
CAD | 0.7 | | |
| | Zerion LT | 0.5 | | IPS e.max CAD | 0.9 | | Polycon ae is indicated to remain in the
mouth only for up to 180 days | | | |
| | Polycon ae | 1.0 | | The IF Titanium Base for Crown with 6 mm
cementable height allows its customization to 4 mm.
In the case of angled structures, the maximum overall
height of the restoration cemented to the Titanium
Base cannot exceed 10 mm. | | | | | | |
| | The CF Titanium Base for Crown with 6 mm cementable
height are supplied without angulation, but allow
customization by reducing the height of cementable area to
4 mm.
Polycon ae is indicated to remain in the mouth only for up
to 180 days | | | | | | | | | |
| Surface
treatment | NP platform: Electrolysis
SP Platform: Machined | | | NP platform: Electrolysis
SP Platform: Machined | | | Machined | | | Identical
Both subject and
predicate devices
(K193234) present the
same surface treatment. |
| Sterilization
Method | Ethylene Oxide to an SAL of 1x10-6
• If customized on the chairside, must be sterilized
before the installation via moist heat (steam),
Gravity displacement or dynamic air removal in | | | Ethylene Oxide to an SAL of 1x10-6
• If customized on the chairside, must be sterilized
before the installation via moist heat (steam),
Gravity displacement or dynamic air removal in | | | Non-sterile/End user sterilized | | | Identical
The subject devices and
the predicate devices
(K193234) share the |
| COMPARISON | SUBJECT DEVICES | | REFERENCE PREDICATE | | REFERENCE PREDICATE | EQUIVALENCE DISCUSSION | | | | |
| | Subject
NUVO CF Implant System
JJGC Indústria e Comércio de Materiais Dentários S.A. | | K193234
NUVO IF Implant System
JJGC Indústria e Comércio de Materiais Dentários S.A. | | K173961
Straumann® BLX Implant System
Institut Straumann AG | | | | | |
| Implant-to-Abutment
Interface | Internal Hex | | Internal Hex | | Internal Hex | Equivalent
The implant interface is
equivalent to that of the
primary predicate device. | | | | |
| Single Use | Yes | | Yes | | Yes | Identical
Subject and predicate devices
are not reusable. | | | | |
| Abutment
Design | Abutment designed to accept a cement-retained
prosthetic.
Angulation: 0°
Coronal Geometry: Conical shape with grooves
Platform Ø: NP - 3.5 & 4.5 mm
SP - 4.5 & 5.5 mm
Gingival Height: NP - 0.5, 1 & 3 mm
SP - 0.5, 1 & 3 mm
Apical Geometry: Internal Hex
Indexing: Non-indexed
Material: Titanium Alloy (Ti-6Al-4V) | | Abutment designed to accept a cement-retained
prosthetic.
Angulation: 0°
Coronal Geometry: Conical shape with grooves
Platform Ø: NP - 3.5 mm
SP - 4.5 & 5.5 mm
Gingival Height: NP - 0.5, 1 & 3 mm
SP - 0.5, 1 & 3 mm
Apical Geometry: Internal Hex
Indexing: Non-indexed
Material: Titanium Alloy (Ti-6Al-4V) | | Abutment designed to accept a
cement-retained prosthetic.
Angulation: 0°
Coronal Geometry: Generally
cylindrical shape
Platform Ø: 3.8, 4.5, 5.5 mm
Gingival Height: 0.75 - 2.5 mm
Apical Geometry: Internal Hex
Indexing: Indexed
Material: Titanium Niobium
Alloy (Ti-6Al-7Nb) | Equivalent
The subject devices and the
primary predicate devices
(K193234) share similar coronal
and apical geometry. The
subject devices present
dimensions contained within
the range of dimension of the
predicate devices (K173961). | | | | |
| CAD/CAM
Restoration
Angulation | Up to 30° | | Up to 30° | | Up to 30° | Identical
Subject and predicate devices
present the same CAD/CAM
Restoration Angulation. | | | | |
| Top half
materials | Material | Minimum
thickness
(mm) | Maximum
allowable
angulation | Material | Minimum
thickness
(mm) | Maximum
allowable
angulation | Material | Minimum
thickness
(mm) | Maximum
allowable
angulation | Equivalent
The subject top half materials
are contained within the scope
of the cleared top half materials
for the predicate devices and
using the same cleared design
parameters.
The subject Titanium Base for
Bridge, when combined with
Polycon ae restoration, can
remain in the mouth for the
same time indicated in the
reference predicate devices
K173961. |
| | Coron (CoCr) | 0.3 | 30° | Coron (CoCr) | 0.3 | 30° | Polycon ae | 0.5 | 30° | |
| | Zerion LT | 0.5 | | Ticon (Titanium) | 0.4 | | IPS | | | |
| | Polycon ae* | 1.0 | | Zirconia (Zerion LT) | 0.5 | | e.max
CAD | 0.7 | | |
| | The restorative element to be bonded to the
Titanium Base shall have a minimum height of 4.9
mm and a maximum height of 10 mm from the
restorative base at the coronal end of the gingival
collar.
The post height of 4.5 mm cannot be reduced.
*Polycon ae is indicated to remain in the mouth
only for up to 180 days | | | The -IF Titanium Base for Bridge with 6 mm
cementable height allows its customization to 4 mm.
In the case of angled structures, the maximum overall
height of the restoration cemented to the Titanium
Base cannot exceed 10 mm. | | | *Polycon ae is indicated to remain in the
mouth only for up to 180 days | | | |

22

Table 12: Substantial Equivalence Comparison – CF Titanium Base for Bridge (Rotational)

23

COMPARISON	SUBJECT DEVICES	REFERENCE PREDICATE	REFERENCE PREDICATE	EQUIVALENCE DISCUSSION
	Subject	K193234	K173961
	NUVO CF Implant System	NUVO IF Implant System	Straumann® BLX Implant System
	JJGC Indústria e Comércio de Materiais Dentários S.A.	JJGC Indústria e Comércio de Materiais Dentários S.A.	Institut Straumann AG
Surface treatment	NP platform: Electrolysis
SP Platform: Machined	NP platform: Electrolysis
SP Platform: Machined	Machined	Identical
Both subject and predicate devices (K193234) present the same surface treatment.
Sterilization Method	Ethylene Oxide to an SAL of 1x10-6 If customized on the chairside, must be sterilized before the installation via moist heat (steam), Gravity displacement or dynamic air removal in 135°C (270°F) for 3 minute exposure.2	Ethylene Oxide to an SAL of 1x10-6 If customized on the chairside, must be sterilized before the installation via moist heat (steam), Gravity displacement or dynamic air removal in 132°C (270°F) for 3 minute exposure.	Non-sterile/End user sterilized	Identical
The subject devices and the predicate devices (K193234) share the same sterilization method.

24

Table 13: Substantial Equivalence Comparison – Titanium Blank CF

COMPARISON	SUBJECT DEVICES		REFERENCE PREDICATE		EQUIVALENCE DISCUSSION
	Subject		K193234
	NUVO CF Implant System
JJGC Indústria e Comércio de Materiais Dentários S.A.		NUVO IF Implant System
JJGC Indústria e Comércio de Materiais Dentários S.A.
Implant-to-
Abutment Interface	Internal Hex		Internal Hex		Equivalent
The implant interface is equivalent to that of the primary predicate device.
Single Use	Yes		Yes		Identical
Subject and predicate devices are not reusable.
Abutment Design	Milling blank with the Implant-to-Abutment interface pre-milled at one end. Used to fabricate patient-specific abutments.
Angulation: 0°
Coronal Geometry: Oversize cylinder for milling
11.5 mm & 15.8 mm diameters
Gingival Height: Not Applicable
Apical Geometry: Internal Hex
Indexing: Indexed
Material: Titanium Alloy (Ti-6Al-4V)		Milling blank with the Implant-to-Abutment interface pre-milled at one end. Used to fabricate patient-specific abutments.
Angulation: 0°
Coronal Geometry: Oversize cylinder for milling
11.5 mm & 15.8 mm diameters
Gingival Height: Not Applicable
Apical Geometry: Internal Hex
Indexing: Indexed
Material: Titanium Alloy (Ti-6Al-4V)		Equivalent
The subject devices and the primary predicate devices share the same coronal and apical geometry.
Sterilization Method	Provided Non-Sterile
Terminally sterilized by user via moist steam via parameters validated to an SAL of 1x10-6		Provided Non-Sterile
Terminally sterilized by user via moist steam via parameters validated to an SAL of 1x10-6		Identical
The subject devices and the primary predicate devices share the same sterilization method.
Surface treatment	Machined (SP platform)
Machined and Electrolysis (NP platform)		Machined (SP platform)
Machined and Electrolysis (NP platform)		Identical
Both subject and predicate devices present the same surface treatment.

25

	SUBJECT DEVICES	REFERENCE PREDICATE	EQUIVALENCE DISCUSSION
COMPARISON	Subject
NUVO CF Implant System
JJGC Indústria e Comércio de Materiais Dentários S.A.	K193234
NUVO IF Implant System
JJGC Indústria e Comércio de Materiais Dentários S.A.	EQUIVALENCE DISCUSSION
Operating
principles	Milling blank with the Implant-to-Abutment interface premilled
at one end. Used to fabricate patient-specific abutments that
are indicated with screw-retained or cement-retained single
restorations	Milling blank with the Implant-to-Abutment interface premilled at
one end. Used to fabricate patient-specific abutments that are
indicated with screw-retained or cement-retained single
restorations	Equivalent
The operating principles of subject
device is the same as the reference
predicate device.
Implant-to-
Abutment
Interface	Internal Hex	Internal Hex	Equivalent
The implant interface is equivalent to
that of the primary predicate device.
Single Use	Yes	Yes	Identical
Subject and predicate devices are not
reusable.
Diameter	Oversize cylinder for milling 11.5 mm & 15.8 mm diameters

Platform Ø: NP – 3.1
SP – 3.6 | Oversize cylinder for milling 11.5 mm & 15.8 mm diameters

Platform Ø NP – 3.5
SP – 4.5 | Identical
Subject and predicate devices present
the same dimensions. |
| Gingival Height | NP – minimum 0.8 mm
SP – minimum 0.8 mm | NP – 0.5, 1 & 3 mm
SP – 0.5, 1 & 3 mm | Equivalent
The minimum gingival height of the
subject devices is within the range of the
gingival heights of the predicate device |
| Angulation | Straight
Angulation of milled abutment: up to 30° | Straight
Angulation of milled abutment: up to 30° | Equivalent
The abutments of the subject devices
and the primary predicate devices are
provided straight and allow a maximum
angulation of up to 30° for the milled
abutment. |
| Raw material | Titanium Alloy (Ti-6Al-4V) | Titanium Alloy (Ti-6Al-4V) | Identical
Subject and predicate devices are
manufactured of the same raw material |
| Surface
Treatment | Machined (SP platform)
Machined and anodized (NP platform) | Machined (SP platform)
Machined and anodized (NP platform) | Identical
Subject and predicate devices present
the same surface treatment |
| Sterilization
Method | Provided Non-Sterile
Terminally sterilized by user via moist steam via parameters validated
to an SAL of 1x10-6 | Provided Non-Sterile
Terminally sterilized by user via moist steam via parameters validated to
an SAL of 1x10-6 | Identical
The subject devices and the primary
predicate devices share the same
sterilization method |

26

NON-CLINICAL PERFORMANCE DATA

Biocompatibility

Biological Safety Assessment for the subject devices was guided by ISO 10993-1 and FDA guidance. Biocompatibility for the subject devices was leveraged from the primary predicate K193234 and reference predicate K173961.

Package transport integrity testing has been performed per ISTA 2A.

Product and package stability have been validated per ASTM F1980.

The implant and abutment surfaces are the same as the cleared predicate devices.

Bench testing

Dynamic fatigue test per ISO 14801 and FDA guidance was performed to determine the fatigue strength for the worst-case constructs assembled using the subject devices.

MRI compatibility testing was leveraged from the reference device K182620.

Sterilization validation

Sterilization of the subject endosseous dental implant devices via gamma irradiation was validated per ISO 11137-1 and ISO 11137-2. A minimum Sterility Assurance Level (SAL) of 1 x 10th has been validated. Sterilization of the subject abutments via ethylene oxide gas was validated per ISO 11135. A minimum Sterility Assurance Level (SAL) of 1 x 10-6 has been validated.

The Subject devices are not represented to be "pyrogen free".

Ethylene oxide residuals have been assessed per ISO 10993-7. Residuals are within accepted limits.

Bacterial Endotoxin Testing are performed on representative samples selected and tested based upon the raw material, manufacturing processes and sterilization process, according to ANSI/AAMI ST72:2011, Bacterial Endotoxins – Test Methods, Routine Monitoring and Alternatives to Batch Testing. The obtained results were