PITT-EASY DENTAL IMPLANT SYSTEM

K083297 · Sybron Implant Solutions GmbH · DZE · Jan 28, 2009 · Dental

Device Facts

• Record ID: K083297
• Device Name: PITT-EASY DENTAL IMPLANT SYSTEM
• Applicant: Sybron Implant Solutions GmbH
• Product Code: DZE · Dental
• Decision Date: Jan 28, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Pitt-Easy Dental Implant System is indicated for use as an endosseous dental implant in the upper or lower jaw arches to provide support for prosthetic devices.

Device Story

Pitt-Easy Dental Implant System is an endosseous root-form dental implant; surgically placed in upper or lower jaw bone to support dental prostheses. System consists of root component (implant) and threaded healing cap; includes screw-retained restorative abutments. Used by dental professionals in clinical settings. Provides structural foundation for prosthetic restoration; benefits patients by replacing missing teeth and restoring oral function. This submission adds a specific contraindication for 3.25mm diameter implants in posterior single-tooth applications.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and material identity to the predicate device.

Technological Characteristics

Endosseous root-form dental implant; consists of implant root component, threaded healing cap, and restorative abutments. No changes to materials or design from predicate.

Indications for Use

Indicated for use as an endosseous dental implant in the upper or lower jaw arches to provide support for prosthetic devices. Contraindicated for 3.25mm diameter implants in single tooth replacement in the posterior region.

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

• Pitt-Easy™ Dental Implant System (K053242)

Submission Summary (Full Text)

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KOS 3297

## Section III - 510(k) Summary

### Submitter:

JAN 2 8 2009

Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 [phone] - Phone . [phone] - Facsimile Wendy Garman - Contact Person

Date Summary Prepared:

November 2008

#### Device Name:

- Trade Name Pitt-Easy Dental Implant System .
- . Common Name - Endosseus Root-Form Implant
- Classification Name Implant, Endosseous Dental, per 21 CFR § 872.3640 .

### Devices for Which Substantial Equivalence is Claimed:

- Sybron Implant Solutions GmbH, Pitt-Easy™ Dental Implant System, K053242 .
#### Device Description:

The Pitt-Easy Dental Implant System is an endosseous dental implant that is intended to be surgically placed in bone of the upper or lower jaw arches to provide support for dental prosthesis. The Pitt-Easy Implant consists of two component parts: the implant (root component) and a threaded healing cap. In addition, attachments that are screw-retained, such as restorative abutments, are available for attachment to the root component.

#### Intended Use of the Device:

The Pitt-Easy Dental Implant System is indicated for use as an endosseous dental implant in the upper or lower jaw arches to provide support for prosthetic devices.

### Substantial Equivalence:

There is no change in composition, design or intended use for the proposed device compared to its predicate and it is considered to be substantially equivalent. The only change being proposed is adding a new contraindication to the Directions for Use (DFU).. The new contraindication states that Pitt-Easy implants of 3.25mm diameter are not suitable for single tooth replacement in the posterior region.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is simple and monochromatic.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Sybron Implant Solutions GmbH C/o Ms. Wendy Garman Director, Regulatory Affairs Sybron Dental Specialties, Incorporation 1717 West Collins Avenue Orange, California 92867

## JAN 2 8 2009

Re: K083297

Trade/Device Name: Pitt-Easy Dental Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: January 19, 2009 Received: January 23, 2009

Dear Ms. Garman.

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 - Ms. Garman

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

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 yours.

Anthony D. mator
Ginette V. Michaud, M.D.

Ginette Y. Michaud, M.D. 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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510(k) Labeling Change Being Effected Sybron Dental Specialties, Inc.

# Indications for Use

510(k) Number (if known):

Device Name: Pitt-Easy Dental Implant System

Indications For Use:

For use as an endosseous dental implant in the upper or lower jaw arches to provide support for prosthetic devices.

Contraindications for the Pitt-Easy 3.25 mm diameter implants are being added to the Directions for Use (DFU).

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Chase

(Division Sign-Off) Division of Anesthesiology, General Hospital infection Control, Dental Devices

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KOS 3297

´í 10(k) Number: ·