CSR

K974865 · Parkell, Inc. · EBI · Mar 16, 1998 · Dental

Device Facts

• Record ID: K974865
• Device Name: CSR
• Applicant: Parkell, Inc.
• Product Code: EBI · Dental
• Decision Date: Mar 16, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

A soft reline material for use by trained dental professionals. The material is a self-polymerizing material that is used to reline the tissue contacting resin surfaces of removable prostheses, either full or partial, to enhance the comfort and fit of said removable prosthetic appliances.

Device Story

CSR is a self-curing (auto-polymerizing) silicone material used by dental professionals to reline removable prosthetic appliances (full or partial). The device consists of a 50ml cartridge, adhesive, and coating agent/glaze. The clinician applies the adhesive to the denture surface, then uses an impression gun to express and mix the silicone through an attached tip directly onto the tissue-contacting surface of the prosthesis. The material polymerizes in situ, remaining soft and adherent to the appliance. This process enhances the fit and comfort of the denture for the patient.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Self-curing (auto-polymerizing) addition-reaction silicone material. Supplied in 50ml cartridges for use with standard impression guns. Includes adhesive and coating agent/glaze. Non-electronic, mechanical delivery system.

Indications for Use

Indicated for use by trained dental professionals to reline tissue-contacting resin surfaces of full or partial removable prosthetic appliances to improve fit and 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.

Predicate Devices

• Acusoft Soft Liner
• Liteline VLC Soft Denture Reline
• Permaflex Permanent Soft Denture Reliner
• Soft Denture Reline Material Elastoline
• Tokuyama Soft Relining

Submission Summary (Full Text)

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KA74865

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## 510(k) SUMMARY

MAR 1 6 1998 Parkell Products Inc. Submitter: 155 Schmitt Blvd. Box 376 Farmingdale, NY 11735 TEL: [phone] FAX: [phone] Nelson J. Gendusa, DDS Contact: Director of Research Parkell 155 Schmitt Blvd. Box 376 Farmingdale, NY 11735 24 December 1997 Submission Date: CSR Trade Name: Denture Reline Material, Soft Common Name: Resin, Denture, Relining, Repairing, Rebasing (§872.3760) Classification Name: Resil, Acusoft Soft Liner, Liteline VLC Soft Denture Reline, Equivalence: Permaflex Permanent Soft Denture Reliner, Soft Denture Reline Material Elastoline, Tokuyama Soft Relining

## Description/Intended Use:

Parkell's CSR is a self-curing (auto-polymerizing) silicone

material that is intended for use by trained and licensed dental professionals as an easy-to-use soft reline material for removable prosthetic appliances, either full or partial, to enhance their fit and comfort. The cured silicone material is affixed to the tissue contacting surfaces of said prosthetic appliances and adheres thereto via the supplied adhesive which is simply applied with a brush. After adhesive application, the CSR silicone is expressed by means of a commonly available impression gun which causes the material to mix within an attached tip so that applied CSR is fully and completely mixed immediately upon its application to the tissue contacting surfaces of a removable prosthetic appliance. Mixed and polymerized CSR remains soft and adherent to tissue contacting over significant periods of time. The adherent silicone is akin to currently available addition-reaction silicone impression materials. The soft reline material is supplied in 50ml cartridges designed for use with impression guns, and kits also include a coating agent or glaze and adhesive necessary to cause a bond between the denture surfaces and the applied silicone.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 6 1998

Nelson J. Gendusa, DDS ·Director of Research Parkell Products, Incorporated 155 Schmitt Boulevard, P.O. Box 376 11735 Farmingdale, New York

K974865 Re : Trade Name: CSR Regulatory Class: II Product Code: EBI Dated: December 19, 1997 December 29, 1997 Received:

Dear Dr. Gendusa:

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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಡಿ 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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Reqister. premarket notification submission does 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 regulations.

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Page 2 - Dr. Gendusa

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 fo
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,

Patueux Crescenti ffr

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): Jif known): Jif Known): Jif Known): Size State State

,

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Device Name: _CSR

Indications for Use: A soft reline material for use by trained dental professionals. The material is a self-polymerizing material that
is used to reline the tissue contacting resin surfaces of removable prostheses, either full or partial, to enhance the comfort and fit of said
removable prosthetic appliances.

| | <div> <img alt="Signature" src="signature.png"/> </div> <div>(Division Sign-Off)</div> <div>Division of Dental, Infection Control,</div> <div>and General Hospital Devices</div> <div>510(k) Number K974865</div> |
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| Prescription Use | <div> <img alt="Check Mark" src="check_mark.png"/> </div> |
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| (Per 21 CFR 801.109) | |