HYDRO-CAST SILICONE SOFT-LINER, MODEL 68400

K992609 · Kay See Dental Mfg. Co. · EBI · Sep 22, 1999 · Dental

Device Facts

• Record ID: K992609
• Device Name: HYDRO-CAST SILICONE SOFT-LINER, MODEL 68400
• Applicant: Kay See Dental Mfg. Co.
• Product Code: EBI · Dental
• Decision Date: Sep 22, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Hydro-Cast / Kay-See Dental Silicone Soft Liner is applied to acrylic dentures for the purpose of providing a soft tissuebearing surface to the denture for patient comfort.

Device Story

Hydro-Cast/Kay-See Dental Silicone Soft Liner is a dental material applied to acrylic dentures. It functions as a soft liner to provide a cushioning interface between the denture base and the patient's oral soft tissues. The device is intended for use by dental professionals in a clinical setting to enhance patient comfort during denture wear. It is a passive material-based device; it does not involve electronic inputs, software, or automated processing.

Clinical Evidence

Bench testing only.

Technological Characteristics

Silicone-based soft liner material for application to acrylic dentures. Class II device (Product Code: EBI).

Indications for Use

Indicated for patients requiring a soft tissue-bearing surface on acrylic dentures to improve comfort.

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 22 1999

Mr. Clark Smith, D.M.D. Executive Vice President Kay-See Dental Manufacturing Company 124 East Missouri Avenue Kansas City, Missouri 64106-1294

K992609 Re : Hydro-Cast/Kay-See Dental Silicone Soft Trade Name: Liner II Requlatory Class: Product Code: EBI August 2, 1999 Dated: Received: August 4, 1999

Dear Dr. Smith:

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. ਸ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation 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 not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Dr. Smith

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 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 requlation 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,

Susan Runne

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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Statement of Indications for Use

Page

## 510(k) Number (if known): _ K 9 92

Device Name:

Hydro-Cast / Kay-See Dental Silicone Soft Liner is applied to Indications For Use: acrylic dentures for the purpose of providing a soft tissuebearing surface to the denture for patient comfort.

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OL

Over-the-Counter Use _

(Division Sign-Off) fermela Scart for Susan Runna
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K992609

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