ECLIPSE WAX REMOVER

K061580 · Dentsply International · EBI · Jul 28, 2006 · Dental

Device Facts

• Record ID: K061580
• Device Name: ECLIPSE WAX REMOVER
• Applicant: Dentsply International
• Product Code: EBI · Dental
• Decision Date: Jul 28, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2

Intended Use

The ECLIPSE® WAX REMOVER is used as an accessory to Eclipse® Prosthetic Resin System to remove wax and aid in adhesion to other acrylic resins in (1) the fabrication of dentures, appliances, and prostheses; (2) repair of dentures, and prostheses; and (3) relining of denture surfaces.

Device Story

Eclipse Wax Remover functions as a chemical accessory for the Eclipse Prosthetic Resin System; used by dental professionals during laboratory fabrication, repair, or relining of dentures and prostheses. The solution facilitates the removal of residual wax from cured resin substructures; improves surface preparation to promote adhesion to subsequent acrylic resin layers. Device application supports the structural integrity of dental prosthetics by ensuring clean bonding surfaces. No complex instrumentation or automated processing required.

Clinical Evidence

Bench testing only; biocompatibility testing for cytotoxicity performed.

Technological Characteristics

Chemical accessory for dental resin systems. Components consist of materials previously used in legally marketed dental devices. Biocompatibility: passed cytotoxicity testing.

Indications for Use

Indicated for use as an accessory to the Eclipse Prosthetic Resin System for wax removal and adhesion promotion during the fabrication, repair, or relining of dentures, appliances, and prostheses.

Regulatory Classification

Identification

A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.

Predicate Devices

• Trubyte Denture Base Resin System (K011560)

Submission Summary (Full Text)

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K061580

JUL 2 8 2006

# 510(k) SUMMARY

DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, PA 17405-0872

| CONTACT: | Helen Lewis |
|----------------------------|-------------------------------------------------------------|
| DATE PREPARED: | June 2, 2006 |
| TRADE OR PROPRIETARY NAME: | ECLIPSE WAX REMOVER |
| CLASSIFICATION NAME: | Denture relining, repairing, or rebasing resin,<br>872.3760 |
| PREDICATE DEVICES: | Trubyte Denture Base Resin System, K011560 |

#### DEVICE DESCRIPTION:

The ECLIPSE® WAX REMOVER is an accessory to the Trubyte® Denture Base Resin System (Eclipse® Prosthetic Resin System). It facilitates the effective removal of wax from cured Eclipse® resin substructures and promotes adhesion to other acrylic resins.

## INTENDED USE:

The ECLIPSE® WAX REMOVER is used as an accessory to Eclipse® Prosthetic Resin System to remove wax and aid in adhesion to other acrylic resins in (1) the fabrication of dentures, appliances, and prostheses; (2) repair of dentures, and prostheses; and (3) relining of denture surfaces.

### TECHNOLOGICAL CHARACTERISTICS:

All of the components found in ECLIPSE® WAX REMOVER have been used in legally marketed devices and/or were found safe for dental use. ECLIPSE® WAX REMOVER has been evaluated and passed biocompatibility testing for cytotoxicity.

We believe that the prior use of the components of ECLIPSE® WAX REMOVER in legally marketed devices, the performance data provided, and the biocompatibility data provided support the safety and effectiveness of the ECLIPSE® WAX REMOVER for the indicated use.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 8 2006

DENTSPLY International. Incorporated Ms. Helen Lewis Director of Corporate Compliance & Regulatory Affairs Dentsply Prosthetics Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17405-0872

Re: K061580

Trade/Device Name: ECLIPSE® WAX REMOVER Regulation Number: 872.3760 Regulation Name: Denture Relining, Repairing or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: June 2, 2006 Received: June 7, 2006

Dear Ms. Lewis:

We have reviewed vour 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 vour 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 - Mr. Lewis

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 (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.

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 Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/edrh/industry/support/index.html.

Sincerely yours.

Chiu Lin. Ph.D.

[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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# INDICATIONS FOR USE

510(K) Number (if known): K061580

ECLIPSE® WAX REMOVER Device Name:

Indications for Use:

The ECLIPSE® WAX REMOVER is used as an accessory to Eclipse® Prosthetic Resin System to remove wax and aid in adhesion to other acrylic resins in (1) the fabrication of dentures, appliances, and prostheses; (2) repair of dentures, and prostheses; and (3) relining of denture surfaces.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) ANDIOR

Over-The-Counter Use __ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert S. Betz DDS for Dr. Susan Renner

K061580