(50 days)
Dental pit and fissure sealant .
Cosmedent PIT & FISSURE SEALANT is a light-cure, moderately filled, resin based dental sealant. The product will cure or harden upon application of visible light at a wavelength of approximately 465 nanometers at an energy of at least 350 milliwatts. PIT & FISSURE SEALANT is a relatively low viscosity polymerizable resin based on bis-GMA, urethane, or similar room temperature curing diacrylate monomers. The product is intended to be applied to the developmental grooves and fissures of teeth to prevent these areas from being damaged by carious organisms. PIT & FISSURE SEALANT is available either as a clear unfilled resin or as a filled resin. The filled resin is white and mimics occlusal tooth color.
This document is a 510(k) summary for a dental pit and fissure sealant. It does not contain information about acceptance criteria or a study proving device performance as typically expected for medical AI/ML devices. Instead, it focuses on the device's description, intended use, and substantial equivalence to a predicate device.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on demonstrating substantial equivalence, not on specific performance criteria derived from a clinical or technical study as would be relevant for an AI/ML device.
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510(k) SUMMARY DEG = 1 2004 As required by the Safe Medical Devices Act of 1990
IDENTIFICATION OF THE LEGALLY MARKETED PREDICATE DEVICES
Bisco Pit and Fissure Sealant is a filled, light-cure, white, resin based sealant designed to seal the pits and fissures of caries susceptible teeth.
This product is fabricated from bis-GMA, urethane, or similar room temperature curing diacrylate monomers that are filled with silanated silica and/or glasses.
DESCRIPTION OF THE APPLICANT DEVICE – PIT & FISSURE SEALANT
Cosmedent PIT & FISSURE SEALANT is a light-cure, moderately filled, resin based dental sealant. The product will cure or harden upon application of visible light at a wavelength of approximately 465 nanometers at an energy of at least 350 milliwatts.
PIT & FISSURE SEALANT is a relatively low viscosity polymerizable resin based on bis-GMA, urethane, or similar room temperature curing diacrylate monomers. The product is intended to be applied to the developmental grooves and fissures of teeth to prevent these areas from being damaged by carious organisms. Poor or negligent oral hygiene is likely to predispose pits and fissures damage by caries since these areas readily collect cariogenic foods
PIT & FISSURE SEALANT is available either as a clear unfilled resin or as a filled resin. The filled resin is white and mimics occlusal tooth color. Although closely matching natural tooth color, the margins of the filled resin are more discernable than the clear resin counterpart.
INTENDED USES OF THE APPLICANT DEVICE
PIT & FISSURE SEALANT is intended to be used to seal the pits and fissures of caries susceptible teeth.
Jarm L. Sandik
James L. Sandrik, PhD
Cosmedent, Inc. 401 N. Michigan Avenue Suite 2500 Chicago, Illinois 60611 Submitted: October 6, 2004
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 1 2004
James L. Sandrik, PhD Director of Regulatory Affairs Cosmedent. Incorporated 401 North Michigan Avenue, Suite 2500 Chicago, Illinois 60611
Re: K042823
Trade/Device Name: Pit & Fissure Sealant Regulation Number: 21 CFR 872.3765 Regulation Name: Pit and Fissure Sealant and Conditioner Regulatory Class: II Product Code: EBC Dated: October 07, 2004 Received: October 12, 2004
Dear Dr. Sandrik:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - James L. Sandrik, PhD
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Anthony D. her
Chiu S. Lin, PhD
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known):
Device Name: MULTIPLE (PIT & FISSURE SEALANT)
Indications For Use:
- Dental pit and fissure sealant .
X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use_ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Rumse
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Device
510(k) Number _
§ 872.3765 Pit and fissure sealant and conditioner.
(a)
Identification. A pit and fissure sealant and conditioner is a device composed of resin, such as polymethylmethacrylate, intended for use primarily in young children to seal pit and fissure depressions (faults in the enamel) in the biting surfaces of teeth to prevent cavities.(b)
Classification. Class II.