TEMPO CUSHION TREATMENT DENTURE RELINE ACRYLIC RESIN LIQUID, PROFESSIONAL SIZE PACKAGE AND POWDER

K081514 · Lang Dental Mfg. Co., Inc. · EBI · Sep 22, 2008 · Dental

Device Facts

• Record ID: K081514
• Device Name: TEMPO CUSHION TREATMENT DENTURE RELINE ACRYLIC RESIN LIQUID, PROFESSIONAL SIZE PACKAGE AND POWDER
• Applicant: Lang Dental Mfg. Co., Inc.
• Product Code: EBI · Dental
• Decision Date: Sep 22, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

LANG DENTAL TEMPO CUSHION TREATMENT DENTURE RELINE ACRYLIC RESIN is intended for the fabrication of denture relines.

Device Story

Lang Dental Tempo Cushion Treatment Denture Reline Acrylic Resin is a dental material used for the fabrication of denture relines. It is intended for professional use by dental clinicians in a clinical setting. The material is applied to existing dentures to improve fit and comfort for the patient. It functions as a relining resin to adjust the denture base to the patient's oral tissues.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Denture relining, repairing, or rebasing resin. Class II device. Product code EBI. Material is an acrylic resin formulation.

Indications for Use

Indicated for patients requiring denture relining procedures. Prescription use only.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## SEP 2 2 2008

Chah M. Shen, Ph.D. Director of Research and Development Lang Dental Manufacturing Company, Incorporated P.O. Box 969, 175 Messner Drive Wheeling, Illinois 60090-0969

Re: K081514

Trade/Device Name: Lang Dental Tempo Cushion Treatment Denture Reline Acrylic Resin Regulation Number: 872.3760 Regulation Name: Denture Relining, Repairing or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: August 26, 2008 Received: September 4, 2008

Dear Dr. Shen:

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 - Dr. Shen

Please be advised that FDA's issuance of a substantial cquivalence 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 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,

Thmnell ferdmir Bell

Chiu S. Lin, Ph. D Division Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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## INDICATIONS FOR USE

4081514

510(k) Number (if known):

Device Name: Lang Dental Tempo Cushion Treatment Denture Reline Acrylic Resin

## Indications for Use:

LANG DENTAL TEMPO CUSHION TREATMENT DENTURE RELINE ACRYLIC RESIN is intended for the fabrication of denture relines.

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Swansunne

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

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

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