HEMASEAL & CIDE

K990779 · Advantage Dental Products, Inc. · LBH · Nov 17, 1999 · Dental

Device Facts

• Record ID: K990779
• Device Name: HEMASEAL & CIDE
• Applicant: Advantage Dental Products, Inc.
• Product Code: LBH · Dental
• Decision Date: Nov 17, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3260
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

HEMASEAL & CIDE is to be used to seal dentinal tubules in cavity preparations or sensitive root surfaces. It also aids in wetting for tubules to provide a better bond for resin fillings and cements.

Device Story

HemaSeal & Cide is a dental material used by clinicians to seal dentinal tubules in cavity preparations or on sensitive root surfaces. The device functions by wetting the tubules, which facilitates improved bonding for subsequent resin fillings and cements. It is applied by dental professionals in a clinical setting to manage dentin sensitivity and enhance restorative procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dental desensitizing and bonding agent. Chemical composition and specific material standards are not detailed in the provided text.

Indications for Use

Indicated for sealing dentinal tubules in cavity preparations or sensitive root surfaces and aiding in tubule wetting to improve bonding for resin fillings and cements.

Regulatory Classification

Identification

Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, into the dentinal tissue.

Special Controls

*Classification.* Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 7 1999

Joseph J. Pelerin, D.D.S. Advantage Dental Products, Inc. P.O. Box 415 Lake Orion, MI 48361

Re: K990779 HemaSeal & Cide Trade Name: Regulatory Class: II ГВН Product Code: Dated: September 23, 1999 September 28, 1999 Received:

## Dear Dr. Pelerin:

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 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

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Page 2 - Dr. Pelerin

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.

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.fdag.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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| T.WC |
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| K990779 | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ | |
| HEMASEAL & CIDE<br>Device Name:__________________________________________________________________________________________________________________________________________________________________ | |
| | |

Indications For Use:

HEMASEAL & CIDE is to be used to seal dentinal tubules in cavity preparations or sensitive root surfaces. It also aids in wetting for tubules to provide a better bond for resin fillings and cements.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use v (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

Susan Nunn

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 5 1 O(k) Number _ 人