LANG DENTAL ACRYLIC PRIMER

K081981 · Lang Dental Mfg. Co., Inc. · EBI · Nov 17, 2008 · Dental

Device Facts

• Record ID: K081981
• Device Name: LANG DENTAL ACRYLIC PRIMER
• Applicant: Lang Dental Mfg. Co., Inc.
• Product Code: EBI · Dental
• Decision Date: Nov 17, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2

Intended Use

LANG DENTAL Acrylic Primer is intended for use as an acrylic bonding agent when adding new acrylic to existing denture base acrylic.

Device Story

Lang Dental Acrylic Primer functions as a chemical bonding agent; applied by dental professionals during denture repair or relining procedures. Device facilitates adhesion between new acrylic resin and existing denture base acrylic; ensures structural integrity of repaired dental prosthetics. Used in clinical dental settings; applied manually by dentists or dental technicians. Benefits patient by enabling effective repair of dentures, extending device lifespan, and maintaining prosthetic function.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Chemical bonding agent for acrylic resins; liquid form; intended for dental prosthetic repair/relining. Class II device under 21 CFR 872.3760.

Indications for Use

Indicated for use as an acrylic bonding agent for dental professionals when adding new acrylic to existing denture base acrylic.

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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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the HHS logo, which is a stylized human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the logo in a circular fashion.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## NOV 1 7 2008

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

Re: K081981

Trade/Device Name: Lang Dental Acrylic Primer Regulation Number: 872.3760 Regulation Name: Denture Relining, Repairing or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: November 10, 2008 Received: November 12, 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 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 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.

Suite y. Mehan Omd.

33. CHILL LIN 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 Acrylic Primer

## Indications for Use:

LANG DENTAL Acrylic Primer is intended for use as an acrylic bonding agent when adding new acrylic to existing denture base acrylic.

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)

Susan Runne

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

510(k) Number:

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