DENOVISMED DENTAL IMPLANT SYSTEMS

K083543 · Denovis Medical, LLC · DZE · Mar 6, 2009 · Dental

Device Facts

• Record ID: K083543
• Device Name: DENOVISMED DENTAL IMPLANT SYSTEMS
• Applicant: Denovis Medical, LLC
• Product Code: DZE · Dental
• Decision Date: Mar 6, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For immediate or delayed placement and function on single-tooth and/or multiple tooth applications in the maxillary and or mandibular arches to support crowns, bridges, and overdentures in edentulous or partially edentulous patients. Immediate loading is indicated for single tooth and/or multiple tooth applications when there is good primary stability and an appropriate occlusal load.

Device Story

DenovisMed Dental Implant System; self-tapping, threaded, root-form dental implants; includes straight abutments and prosthetic components. Used by dental professionals to restore esthetics and chewing function in edentulous or partially edentulous patients. Implants placed in maxillary or mandibular arches to support crowns, bridges, or overdentures. Immediate or delayed loading protocols supported. System provides mechanical foundation for prosthetic restoration; clinical benefit includes restoration of oral function and esthetics.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and material characteristics.

Technological Characteristics

Self-tapping, threaded, root-form dental implant system; includes straight abutments and prosthetic components. Materials and sterilization processes are equivalent to predicate devices.

Indications for Use

Indicated for edentulous or partially edentulous patients requiring dental restoration via crowns, bridges, or overdentures in maxillary or mandibular arches. Immediate loading permitted given good primary stability and appropriate occlusal load.

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.

Submission Summary (Full Text)

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K083543

DenovisMed Dental Implant System

# 510(k) Summary

MAR 6 2009

## Denovis Medical, LLC DenovisMed Dental Implant System

### ADMINISTRATIVE INFORMATION

| Manufacturer Name: | Denovis Medical, LLC<br>1121 N. Bethlehem Pike, Suite 60-104<br>Spring House, Pennsylvania 19477, USA<br>Telephone: [phone]<br>Fax: [phone] |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Roger Ranck<br>Denovis Medical, LLC<br>Telephone: [phone]<br>Fax: [phone]<br>email: [e-mail] |
| Representative/Consultant: | Kevin A. Thomas<br>Floyd G. Larson<br>PaxMed International, LLC<br>11234 El Camino Real, Suite 200 |

San Diego, CA 92130

Telephone: [phone] Fax: [phone] email: [e-mail] [e-mail]

## DEVICE NAME AND CLASSIFICATION

DenovisMed Dental Implant System Trade/Proprietary Name: Dental implant; Dental implant abutment Common Name: Implant, endosseous, root-form; Classification Regulations: Endosseous dental implant abutment 21 CFR 872.3640, 21 CFR 872.3630 Class II DZE; NHA Product Codes Dental Products Panel Classification Panel: Dental Devices Branch Reviewing Branch:

510(k) Summary

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#### 510(k) Summary

#### INTENDED USE

For immediate or delayed placement and function on single-tooth and/or multiple tooth applications in the maxillary and or mandibular arches to support crowns, bridges, and overdentures in edentulous or partially edentulous patients. Immediate loading is indicated for single tooth and/or multiple tooth applications when there is good primary stability and an appropriate occlusal load.

### DEVICE DESCRIPTION

The DenovisMed Dental Implant System is intended to support prosthetic devices in edentulous or partially edentulous patients to restore esthetics and chewing function. The System consists of the DenovisMed Dental Implant, a self-tapping, threaded, root-formed dental implant as well as straight abutments and related prosthetic components.

#### EQUIVALENCE TO MARKETED DEVICE

Denovis Medical, LLC demonstrated that, for the purposes of FDA's regulation of medical devices, the DenovisMed Dental Implant System is substantially equivalent in indications and design principles to predicate devices, each of which has been determined by FDA to be substantially equivalent to preamendment devices. Overall, the DenovisMed Dental Implant System has the following similarities to the predicate devices:

- has the same intended use, .
- uses the same operating principle, .
- incorporates the same basic design, .
- incorporates the same materials, and .
- has similar packaging and is sterilized using the same materials and processes.

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Public Health Service

MAY 19 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Denovis Medical, LLC C/o Kevin A. Thomas, Ph.D. Senior Regulatory Specialist PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, California 92130

Re: K083543

Trade/Device Name: DenovisMed Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: February 11, 2009 Received: February 12, 2009

Dear Dr. Thomas:

This letter corrects our substantially equivalent letter of March 6, 2009.

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 (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.

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- Dr. Thomas

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 device-related 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Susan Bunner

Susan Runner, DDS, MA Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K083543

### 510(k) Premarket Notification

DenovisMed Dental Implant System

### Indications for Use

510(k) Number (if known): K083543

DenovisMed Dental Implant System Device Name:

Indications for Use:

For immediate or delayed placement and function on single-tooth and/or multiple tooth applications in the maxillary and or mandibular arches to support crowns, bridges, and overdentures in edentulous or partially edentulous patients. Immediate loading is indicated for single tooth and/or multiple tooth applications when there is good primary stability and an appropriate occlusal load.

Prescription Use X (Part 21 CFR 801 Subpart D)

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

200
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Divisa
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ﺮﺍﻧﺪ ۳۰۰ ﺗﻮﺍﻧﻪ ! Division (Divisity Concurrence of CDRH, Office of Device Evaluation (ODE) Division of Anesthasiology, Gearn. . . . . . . . . . . . . . . . . Infection Control. Dental Devices

510(k) Number: K083543