HURRISEAL DENTIN DESENSITIZER

K973002 · Cheng & Assoc., Inc. · KLE · Mar 23, 1998 · Dental

Device Facts

• Record ID: K973002
• Device Name: HURRISEAL DENTIN DESENSITIZER
• Applicant: Cheng & Assoc., Inc.
• Product Code: KLE · Dental
• Decision Date: Mar 23, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

HurriSeal® is a desensitizer with fluoride and benzalkonium chloride to be applied prior to restorative procedures by the dental professional.

Device Story

HurriSeal® Dentin Desensitizer is a topical dental agent containing fluoride and benzalkonium chloride. Applied by dental professionals prior to restorative procedures to reduce dentin sensitivity. Functions as a chemical treatment to seal dentinal tubules or provide desensitizing effects. Used in clinical dental settings. Benefits patient by mitigating post-operative sensitivity associated with restorative dental work.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on regulatory review of device characteristics and intended use.

Technological Characteristics

Chemical composition includes fluoride and benzalkonium chloride. Topical liquid/gel form factor for dental application. No electronic, software, or mechanical components.

Indications for Use

Indicated for use by dental professionals as a desensitizer containing fluoride and benzalkonium chloride, applied prior to restorative dental procedures.

Regulatory Classification

Identification

A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 3 1998

Ms. An-Shih Cheng Cheng & Associates, Incorporated 415 West Aldine Avenue, #10-A Chicago, Illinois 60657-3602

K973002 Re : Hurriseal® Dentin Desensitizer Trade Name: Requlatory Class: II Product Code: KLE January 30, 1998 Dated: February 3, 1998 Received:

Dear Ms. An-Shi Cheng:

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. ਰੈ 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 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 - Ms. An-Shih Cheng

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 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 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

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): ____________________________________________________________________________________________________________________________________________________

HurriSeal® Dentin Desensitizer Device Name:

Indications For Use:

HurriSeal® is a desensitizer with fluoride and benzalkonium chloride to be applied prior to restorative procedures by the dental professional.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rumpler

(Division Sign-Off) Division of Damal, Infection Control, and General Hospital Devices 510(k) Number S 300F

Prescription User (Per 21 CFR 801.109) OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________