DURAFLEX

K063626 · Cosmetic Dental Materials, Inc. · EBI · Feb 8, 2007 · Dental

Device Facts

• Record ID: K063626
• Device Name: DURAFLEX
• Applicant: Cosmetic Dental Materials, Inc.
• Product Code: EBI · Dental
• Decision Date: Feb 8, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DuraFlex thermoplastic resin is used for the fabrication of partial or full removable dentures, as well as occlusal splints and night guards.

Device Story

DuraFlex is a thermoplastic resin used by dental professionals to fabricate partial or full removable dentures, occlusal splints, and night guards. The material is processed via injection molding or pressing devices. It serves as a restorative dental material, providing a flexible alternative for prosthetic applications. The device is used in a dental laboratory or clinical setting to create custom-fit appliances that improve patient oral function and comfort.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Thermoplastic resin; used with injection molding or pressing equipment; Class II dental device (21 CFR 872.3760).

Indications for Use

Indicated for the fabrication of partial or full removable dentures, occlusal splints, and night guards in patients requiring dental 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

• Lucitone FRS Flexible Dental Resin

Submission Summary (Full Text)

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K063626

Image /page/0/Picture/1 description: The image shows the logo for Cosmetic Dental Materials, with the acronym "cdm" in bold, black letters. To the right of the acronym, the full name of the company is written in a smaller font. In the upper right corner of the image, the abbreviation "FEB" is visible.

8 2007

CDM Inc. 812 Water Ave NE Albany OR 97321 Phone: [phone] Fax: [phone]

# 510 (K) Summary

Submitter Name:

Submitter Address:

Submitter Telephone: Submitter Facsimile:

Contact Person:

CDM Inc.

812 Water St NE Albany OR 97321

541-928-4444 541-928-2444

Bob Bowers Chief Operating Officer

Date Summary Prepared:

October 23, 2006

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CDM Inc. DuraFlex Original Premarket 510(K) Notification

# SECTION 9: 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(K) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR.807.92.

### 9.1 SUBMITTER INFORMATION

| a. Company Name: | CDM Inc. |
|---------------------------------------------|---------------------------------------|
| b. Company Address: | 812 Water St NE<br>Albany OR 97321 |
| c. Company Telephone:<br>Company Facsimile: | 541-928-4444<br>541-928-2444 |
| d. Contact Person: | Bob Bowers<br>Chief Operating Officer |
| e. Date Summary Prepared: | October 23, 2006 |
| 9.2 DEVICE IDENTIFICATION | |
| a. Trade/Proprietary Name: | DuraFlex |
| b. Classification Name: | Denture relining, repairing or re |

Denture relining, repairing or rebasing resin. 21 CFR 872.3760

# 9.3 IDENTIFICATION OF PREDICATE DEVICES

The DuraFlex material is a thermoplastic resin used to fabricate partial or full removable dentures, as well as occlusal splints and night guards. This material is substantially equivalent to Lucitone FRS Flexible Dental Resin manufactured by Dentsply International. This material is commercially available in the United States.

#### 9.4 DEVICE DESCRIPTION

The DuraFlex material is a thermoplastic resin that is used to fabricate dental prostheses. The resin is used in an injection molding or pressing device to fabricate the prostheses.

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CDM Inc. DuraFlex Original Premarket 510(K) Notification

# 9.5 SUBSTANTIAL EQUIVALENCE

The DuraFlex thermoplastic resin is substantial equivalent to Lucitone FRS Flexible Dental Resin. The fundamental characteristics are similar: the DuraFlex thermoplastic resin is similar in design, function, physical properties and intended use to the predicate device.

### 9.6 INDICATIONS FOR USE

The DuraFlex material is a thermoplastic resin intended for the fabrication of partial or full removable dentures, as well as occlusal splints and night guards.

# 9.7 TECHNOLOGICAL CHARACTERISTICS

Both the DuraFlex and the predicate device are similar in design, material characteristics, physical properties, handling characteristics, intended use and functionality.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract human figure with outstretched arms.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Robert Bowers Chief Operating Officer CDM, Incorporated 812 Water Avenue, NE Albany, Oregon 97321

FEB \$ 2007

Re: K063626

Trade/Device Name: DuraFlex™ Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: January 29, 2007 Received: February 05, 2007

Dear Mr. Bowers:

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 coan. 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 an be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FFD may public further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Robert Bowers

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" (21 CFR 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/cdrh/industry/support/index.html.

Sincerely yours,

Sura Ruano

Chiu S. Lin. PhD 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 | K063626 |
|---------------|----------|
| Device Name | DuraFlex |

Page 1 of 1

Indications for use:

The DuraFlex thermoplastic resin is used for the fabrication of partial or full removable dentures, as well as occlusal splints and night guards. Dental Device Class II, 872.3760

Do not write below this line - Continue on another page if needed

Prescription Use
(Per 21 CFR 801.109)

OR

Over the counter
(Optional Format 1-2-96)

(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K63676