LANG DENTAL RESIN A97 FIBRED PINK

K972553 · Lang Dental Mfg. Co., Inc. · EBI · Nov 13, 1997 · Dental

Device Facts

• Record ID: K972553
• Device Name: LANG DENTAL RESIN A97 FIBRED PINK
• Applicant: Lang Dental Mfg. Co., Inc.
• Product Code: EBI · Dental
• Decision Date: Nov 13, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2

Intended Use

Lang Dental Resin A97 Fibred Pink is a self-curing powder/liquid resin developed for the fabrication of removable partial dentures and for reconditioning dentures for processes such as repairs, relines and modulation of margins and extension.

Device Story

Lang Dental Resin A97 Fibred Pink is a self-curing powder/liquid resin system. Used by dental professionals for fabricating removable partial dentures and performing denture reconditioning tasks including repairs, relines, and margin/extension modulation. Device functions via chemical polymerization of powder and liquid components to form a hardened dental appliance or repair material.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Self-curing powder/liquid resin system. Class II device (Product Code EBI).

Indications for Use

Indicated for fabrication of removable partial dentures and reconditioning (repairs, relines, modulation of margins/extension) of dentures.

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/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle's head and wing, formed by three overlapping profiles of human faces. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 3 1997

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

K972553 Re: Lang Dental Resin A97 Fibred Pink Trade Name: Requlatory Class: II Product Code: EBI Dated: Auqust 28, 1997 Received: September 4, 1997

Dear Dr. Shen:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. ਉ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does

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Page 2 - Dr. Shen

not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

J. Cilchriat

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page **_ of _**

×97×553 510(k) Number (if known): Dental Resin A97 Device Name:_

Indications For Use:

Lang Dental Resin A97 Fibred Pink is a self-curing powder/liquid resin developed for the fabrication of removable partial dentures and for reconditioning dentures for processes such as repairs, relines and modulation of margins and extension.

(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 of Dental, Infection Control, and General Hospital Devic 510(k) Number .

Prescription Use_ (Per 21 CFR 801.109) OR

Over-The-Counter Use \$\mathcal{W}_O\$

(Optional Format 1-2-96)