LINER 1:HARD RELINE LIQUID

K981861 · Harry J. Bosworth Co. · EBI · Oct 1, 1998 · Dental

Device Facts

• Record ID: K981861
• Device Name: LINER 1:HARD RELINE LIQUID
• Applicant: Harry J. Bosworth Co.
• Product Code: EBI · Dental
• Decision Date: Oct 1, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Hard Reline Liquid is used as a hard liner and repair material for removable dentures.

Device Story

Liner I: Hard Reline Liquid is a dental material used by dental professionals for the relining and repair of removable dentures. The device functions as a hard liner to improve the fit and structural integrity of existing denture prosthetics. It is applied in a clinical dental setting to address patient needs for denture maintenance or adjustment. The material provides a durable surface to restore proper occlusion and comfort for the patient.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dental hard reline and repair material. Chemical composition and physical properties consistent with standard denture reline materials. Class II device, product code EBI.

Indications for Use

Indicated for use as a hard liner and repair material for removable 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/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three lines forming its head and wings, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

1 1998 OCT

Mildred M. Goldstein President Harry J. Bosworth Company 7227 North Hamlin Avenue Skokie, Illinois 60076

K981861 Re: Trade Name: Liner 1: Hard Reline Liquid Requlatory Class: II Product Code: EBI September 15, 1998 Dated: Received: September 23, 1998

Dear Ms. Goldstein:

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 leqally 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Ms. Goldstein

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 findinq of substantial equivalence of your device to a leqally 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 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" (CFR 807.97). Other qeneral 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/dsma/dsmamain.html".

Sincerely yours,

Patricia Cucurita/for

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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510(k) Number (if known): Number: K981861

Device Name: LINER I: HARD RELINE LIQUID

INDICATIONS FOR USE:

Hard Reline Liquid is used as a hard liner and repair material for removable dentures.

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

Concurrence of CDRH, Office of Device Evaluation (ODF)

Prescription Use (Pcr 21 CFR 801.109)

: 上

OR

Over-the-Counter Use

(Optional Formal 1-2-96)

Susan Russo

(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number k981861