Neodent Implant System

K150199 · Jjgc Industria E Comercio DE Materiais Dentarios S · DZE · Jun 15, 2015 · Dental

Device Facts

• Record ID: K150199
• Device Name: Neodent Implant System
• Applicant: Jjgc Industria E Comercio DE Materiais Dentarios S
• Product Code: DZE · Dental
• Decision Date: Jun 15, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2

Intended Use

CM Alvim Acqua Implant The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly splinted. Facility Acqua Implant The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. The Facility implant is indicated for replacement of maxillary lateral incisors, mandibular incisors or retention of overdentures. CM Anatomic Abutment, Exact Anatomic, Lateral Anatomic, and Lateral Anatomic Abutments The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

Device Story

Neodent Implant System consists of threaded, self-tapping, root-form endosseous dental implants and associated abutments; features Morse taper (CM) interface. Implants surgically placed in jawbone by dental professionals to support prosthetic teeth. CM Alvim Acqua implants (unalloyed titanium Grade 4) and Facility Acqua implants (Ti-6Al-4V ELI alloy) feature hydrophilic 'Acqua' surface (grit-blasted/acid-etched). Abutments (Ti-6Al-4V ELI) include 17° angled anatomic designs with scalloped margins for gingival contouring. System restores chewing function and esthetics. Clinical benefit derived from stable prosthetic support. No software or algorithms involved.

Clinical Evidence

No clinical data submitted. Substantial equivalence supported by non-clinical bench testing, including biocompatibility, engineering analysis, dimensional analysis, and animal histology data comparing subject devices to predicates in sheep tibiae.

Technological Characteristics

Materials: Unalloyed Titanium Grade 4 (ASTM F67) for CM Alvim Acqua; Titanium-6Aluminum-4Vanadium ELI (ASTM F136) for Facility Acqua and abutments. Design: Threaded, self-tapping, root-form endosseous implants with Morse taper interface. Surface: Hydrophilic grit-blasted and acid-etched (NeoPoros). Abutments: 17° angled, anatomic, cement-retained. Sterilization: Same processes as predicates.

Indications for Use

Indicated for patients requiring dental restoration via endosseous implants in the upper or lower jaw. Facility Acqua implants specifically indicated for replacement of maxillary lateral incisors, mandibular incisors, or retention of overdentures. Suitable for single or multiple unit restorations; single or two-stage procedures; immediate loading permitted given sufficient primary stability.

Regulatory Classification

Identification

An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.

Special Controls

*Classification.* (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2) *Classification.* Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use; (ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads; (iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system; (iv) The device must be demonstrated to be biocompatible; (v) Sterility testing must demonstrate the sterility of the device; (vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment; (vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians; (viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and (ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.

Predicate Devices

• Neodent Implant System (K133592)
• Neodent Implant System (K101945)
• Neodent Implant System (K123022)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 15, 2015

JJGC Industria E Comercio De Materiais Dentarios SA c/o Kevin A. Thomas, Ph.D. PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130

Re: K150199 Trade/Device Name: Neodent Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: May 13, 2015 Received: May 14, 2015

Dear Dr. Thomas:

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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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Page 2 - Kevin A. Thomas, Ph.D.

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina
Kiang -S

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known)

#### K150199

Device Name

Neodent Implant System

Indications for Use (Describe)

#### CM Alvim Acqua Implant

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

#### Facility Acqua Implant

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

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

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

The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage 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.

| 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> |

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# K150199 510(k) Summary

# JJGC Indústria e Comércio de Materiais Dentários SA

# Neodent Implant System

May 13, 2015

# ADMINISTRATIVE INFORMATION

| Manufacturer Name | JJGC Indústria e Comércio de Materiais Dentários S<br>Av. Juscelino Kubitschek de Oliveira, 3291 - CIC<br>Curitiba, Paraná, 81270-200, Brazil<br>Telephone: [phone]<br>Fax: [phone] | |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Official Contact | Jacson Cambruzzi<br>Head of Quality and Regulatory Affairs | |
| Representative/Consultant | Kevin A. Thomas, PhD<br>PaxMed International, LLC<br>12264 El Camino Real, Suite 400<br>San Diego, CA 92130<br>Telephone: [phone]<br>Fax: [phone]<br>Email: [e-mail] | |

# DEVICE NAME AND CLASSIFICATION

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

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# INTENDED USE

### CM Alvim Acqua Implant

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

## Facility Acqua Implant

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

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

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

## DEVICE DESCRIPTION

The purpose of this submission is to expand the Neodent Implant System components cleared under K101945, K123022, and K133592; these submissions included dental implants with a Morse taper (CM) abutment interface, mating abutments, abutment screws, and other associated components. The additions included in this submission are CM Alvim Acqua and Facility Acqua implants, and 17° angled anatomic abutments.

All of the subject device implants are threaded, self-tapping, root form, endosseous dental implants with Morse taper abutment interfaces. The CM Alvim Acqua implants are made from unalloyed titanium, Grade 4, conforming to ASTM F67 Standard Specification for Unalloved Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700). The Facility Acqua implants are made from titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). All implants have the "Acqua" surface cleared in K133592. The Acqua surface begins with the traditional grit blasted and acid etched endosseous surface (branded "NeoPoros"), which is identical to that used on implants cleared in K101945 and K123022. The NeoPoros surface undergoes additional

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processing that renders the surface hydrophilic. The CM Alvim Acqua implants are provided in 3.5, 4.3, and 5.0 mm diameters: each diameter is provided in 8, 10, 11.5, 13. and 16 mm lengths. The Facility Acqua implant is provided with a 2.9 mm diameter in 8, 10, 12, 14, and 16 mm lengths.

This submission includes four series of cement-retained abutments intended for single unit prostheses in the esthetic zone. Each series has scalloped margins to follow the gingival contour to provide better esthetic results with the final prosthesis. The series include CM Anatomic and CM Lateral Anatomic abutments, each without and with an internal indexing feature (branded "Exact") at the apical end of the Morse taper connection. All abutments are angled 17°, are provided in 1.5, 2.5, and 3.5 mm gingival heights, and are made from titanium alloy conforming to ASTM F136.

# PERFORMANCE DATA

Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include: biocompatibility, engineering analysis, and dimensional analysis. Animal histology data were presented comparing predicate devices to the subject devices implanted in sheep tibiae.

Clinical data were not submitted in this premarket notification.

# EQUIVALENCE TO MARKETED DEVICE

Neodent Implant System is substantially equivalent in indications and design principles to the following legally marketed predicate devices:

K133592, Neodent Implant System, Neodent USA, Inc.;

K101945, Neodent Implant System, JJGC Indústria e Comércio de Materiais Dentários SA; and

K123022. Neodent Implant System. JJGC Indústria e Comércio de Materiais Dentários SA.

The primary predicate device is K123022. Reference predicates are K133492 and K101945.

The implants in this submission have similar designs and dimensions, use the same materials, and have the same surface as those cleared under K133592. K101945. and K123022. The CM Alvim Acqua implant design is identical to the design of the Alvim CM implant cleared in K101945. The Facility Acqua implant design is identical to the design of the Facility implant cleared in K123022. The Acqua surface treatment is identical to that cleared in K133592.

The abutments in this submission have similar designs and are made from the same material as those cleared under K101945 and K123022.

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The subject device implant and abutments have similar packaging and are sterilized using the same processes as described in K133592, K101945, and K123022.

## CONCLUSION

The subject device and the predicate devices have intended use, have similar technological characteristics, and are made of similar materials. The subject device and predicate devices encompass the same range of physical dimensions, including diameter and length of the implants, and diameter, height and angle of the abutments. The subject and predicate devices are packaged in similar materials and sterilized using similar methods. Any differences in the technological characteristics do not raise new questions of safety or effectiveness.

The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.