THERMOFORM SHEET MATERIALS AND ACCESSORIES

K072522 · Dentsply International, Inc. · MQC · Nov 16, 2007 · DE

Device Facts

• Record ID: K072522
• Device Name: THERMOFORM SHEET MATERIALS AND ACCESSORIES
• Applicant: Dentsply International, Inc.
• Product Code: MQC · DE
• Decision Date: Nov 16, 2007
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U

Intended Use

THERMOFORM SHEET MATERIALS AND ACCESSORIES are indicated for the fabrication of orthodontic and dental appliances.

Device Story

Thermoform Sheet Materials consist of flat thermoplastic sheets. Practitioner heats sheets and vacuum-forms them over dental impression of patient's teeth; material is then trimmed to fit. Accessories consist of sheet material formulations produced via injection molding. Used in dental clinic setting by dental professionals to create custom orthodontic and dental appliances.

Clinical Evidence

No clinical data. Substantial equivalence is supported by biocompatibility testing and the history of use of the device components in legally marketed dental devices.

Technological Characteristics

Thermoplastic sheet materials and injection-molded accessories. Sensing/actuation: None (mechanical forming). Energy source: External heat source (required for forming). Connectivity: None. Sterilization: Not specified. Software: None.

Indications for Use

Indicated for the fabrication of orthodontic and dental appliances in patients requiring such devices.

Predicate Devices

• K062828

Submission Summary (Full Text)

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# 072522

### 510(k) SUMMARY

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

K062828

| CONTACT: | Helen Lewis | NOV 1 6 2007 | |
|----------------------------|--------------------------------------------|--------------|--------------------------|
| DATE PREPARED: | SEP 0 6 2007 | | |
| TRADE OR PROPRIETARY NAME: | THERMOFORM SHEET MATERIALS AND ACCESSORIES | | |
| CLASSIFICATION NAME: | Sequential Aligner<br>Mouthguard | NXC<br>MQC | 872.5470<br>Unclassified |

DEVICE DESCRIPTION: Thermoform Sheet Materials are flat sheets of thermoplastic. The sheets are heated by the practitioner and then vacuum-formed over a dental impression of the patient's teeth. The sheet is then trimmed to fit. The Accessories are sheet material formulations manufactured by injection molding.

Mouthguard and Aligner Materials

INTENDED USE: Thermoform Sheet Materials and Accessories are indicated for the fabrication of orthodontic and dental appliances.

TECHNOLOGICAL CHARACTERISTICS: All of the components found in Thermoform Materials and Accessories have been used in legally marketed devices and/or were found safe for dental use. Appropriate biocompatibility testing has been completed.

We believe that the prior use of the components of Thermoform Sheet Materials and Accessories in legally marketed devices and the biocompatibility data provided support the safety and effectiveness of Thermoform Sheet Materials and Accessories for the indicated uses.

000011

PREDICATE DEVICES:

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a symbol of three stylized human figures. The figures are connected and represent the health and well-being of individuals and families. The seal is in black and white.

## NOV 1 6 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K072522

Trade/Device Name: THERMOFORM SHEET MATERIALS AND ACCESSORIES Regulation Number: Unclassified Regulation Name: None Regulatory Class: Unclassified Product Code: MOC Dated: September 6, 2007 Received: September 7, 2007

Dear Ms. Lewis:

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. 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/cdrh/industry/support/index.html.

Sincerely yours.

Mitfor Ogl
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 STATEMENT

510(k) Number (if known):

THERMOFORM SHEET MATERIALS AND ACCESSORIES Device Name:

Indications for Use:

THERMOFORM SHEET MATERIALS AND ACCESSORIES are indicated for the fabrication of orthodontic and dental appliances.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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)

Suor Kuarez

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

510(k) Number: K072522