LANG DENTAL RESINCAP PATTERN AND COPING ACRYLIC RESIN

K081705 · Lang Dental Mfg. Co., Inc. · EBG · Sep 17, 2008 · Dental

Device Facts

• Record ID: K081705
• Device Name: LANG DENTAL RESINCAP PATTERN AND COPING ACRYLIC RESIN
• Applicant: Lang Dental Mfg. Co., Inc.
• Product Code: EBG · Dental
• Decision Date: Sep 17, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3770
• Device Class: Class 2

Intended Use

LANG DENTAL RESINCAP PATTERN AND COPING ACRYLIC RESIN is intended for the fabrication of patterns and copings.

Device Story

Lang Dental Resincap Pattern and Coping Acrylic Resin is a dental material used by dental professionals for the fabrication of patterns and copings. The device is applied in a clinical or laboratory setting to create temporary structures for dental restorations. It functions as a resin-based material that is shaped and cured to form the required dental patterns. The output is a physical pattern or coping used by the dentist to facilitate the creation of final dental prosthetics, aiding in the restorative process for the patient.

Clinical Evidence

Bench testing only.

Technological Characteristics

Acrylic resin material; used for temporary crown and bridge applications; Class II device; Regulation 872.3770; Product Code EBG.

Indications for Use

Indicated for the fabrication of dental patterns and copings in patients requiring restorative dental procedures.

Regulatory Classification

Identification

A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle. The eagle is black, and the text is in a smaller font size.

Public Health Service

## SEP 1 7 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K081705

Trade/Device Name: Lang Dental Resincap Pattern and Coping Acrylic Resin Regulation Number: 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Codc: EBG Dated: September 2, 2008 Received: September 8, 2008

Dear Dr. Shen:

We have reviewed your Scction 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 equivalence determination docs 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 vour 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.

TK Manuel for Linsbury fox//

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

Enclosure

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## INDICATIONS FOR USE

## 510(k) Number (if known):

Device Name: Lang Dental Resincap Pattern and Coping Acrylic Resin

## Indications for Use:

LANG DENTAL RESINCAP PATTERN AND COPING ACR YLIC RESIN is intended for the fabrication of patterns and copings.

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)

- 1704

Susan Suarez

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

10(k) Number:

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