(59 days)
Clear Bravo is a clear, light-cured pit and fissure sealant and sealer for application to the surfaces of teeth, sealing of composite margins and temporary restorations Clear Bravo is available in either fluoride and non-fluoride releasing formulas
Clear Bravo is a clear, light-cured pit and fissure sealant and sealer for application to the surfaces of teeth, sealing of composite margins and temporary restorations Clear Bravo is crystal clear which allows observation of conditions which may occur beneath the sealant This would include possible leakage, staming and also allows the use of canes detecting devices Clear Bravo is available in either fluoride and non-fluoride releasing formulas
The provided text describes a 510(k) premarket notification for a dental device called "Clear Bravo," a pit and fissure sealant. However, the document does not contain information about acceptance criteria for device performance, nor details of a study with specific performance metrics to prove these criteria are met.
The document primarily focuses on:
- Identifying the device, its classification, and product code.
- Listing predicate devices and stating that Clear Bravo is substantially equivalent to them.
- Defining the intended use and description of Clear Bravo.
- Confirming the FDA's decision to allow marketing of the device based on substantial equivalence to predicate devices, without requiring a premarket approval application (PMA).
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them from the given text. The text does not include any performance data, study designs, sample sizes, expert qualifications, or ground truth methodologies.
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Image /page/0/Picture/0 description: The image shows the logo for Denali Corporation. The logo consists of a stylized mountain graphic on the left, followed by the words "denali corporation" in a bold, sans-serif font. The mountain graphic appears to be a triangle with a curved line extending from the top.
Image /page/0/Picture/1 description: The image contains the handwritten text "KOS 3473" at the top. Below this, the text "510 (k) Premarket Notification" is printed in a smaller font size. The text appears to be part of a document or form, possibly related to a premarket notification process.
SUMMARY OF SAFETY AND EFFECTIVENESS DATA
Dr Jan G Stannard 134 Old Washington Street Hanover, MA 02339-1629
Telephone 781-826-9190 781-826-9190 Fax । stannard@comcast net
DEVICE
Trade Name Clear Bravo Classification Name Pit and Fissure Sealant and Conditioner FDA Product Code EBC 872 3765
JAN 22 2009
PREDICATE DEVICES CosmeSeal Pit and Fissure Sealant
UltraSeal XT Pit and Fissure Sealant and Flowable Composite Kit Delton Clear Pit and Fissure Sealant Kit
INDICATIONS FOR USE
Clear Bravo is a clear, light-cured pit and fissure sealant and sealer for application to the surfaces of teeth, sealing of composite margins and temporary restorations Clear Bravo is available in either fluoride and non-fluoride releasing formulas
DESCRIPTION AND INTENDED USE
Clear Bravo is a clear, light-cured pit and fissure sealant and sealer for application to the surfaces of teeth, sealing of composite margins and temporary restorations Clear Bravo is crystal clear which allows observation of conditions which may occur beneath the sealant This would include possible leakage, staming and also allows the use of canes detecting devices Clear Bravo is available in either fluoride and non-fluoride releasing formulas
COMPARISON WITH PREDICATE PRODUCTS
Clear Bravo has been found to be substantially equivalent in design, composition and intended use to the products listed above
SAFETY AND EFFECTIVENESS
The predicate products have been found substantially equivalent under the 510(k) premarket notification process as Class II Dental Devices under CFR 21
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od and Drug Administration 200 Corporate Boulevard Rockville MD 20850
JAN 2 2 2009
Ms Jan G Stannard President Denalı R&D Corporation 134 Old Washington Street Hanover Massachusetts 02339-1629
Re K083473
I rade/Device Name Clear Bravo Regulation Number 21 CI·R 872 3765 Regulation Name Pit and Fissure Scalant and Conditioner Regulatory Class II Product Code EBC Dated November 19, 2008 Received November 24, 2008
Dear Ms Stannard
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 ton 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 I ederal I'ood, 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 lound in the Code of Federal Regulations, Title 21, Parts 800 to 898 In addition, I DA may publish further announcements concerning your device in the Ecderal Register
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Page 2 - Ms Stannard
Please be advised that FDA's issuance of a substantial equivalence determination does not mcan 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 (QS) 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, permiss 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807 97) For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474 For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the DIVISION of Surveillance Systems at 240-276-3464 You may obtain other gencral 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 (240) 276-3150 or at its Internet address http //www fda gov/cdrh/industry/support/index html
Sincerely yours,
Antony V. Watson for
Ginette Y Michaud, M D
Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Inclosure
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Image /page/3/Picture/1 description: The image shows the logo for Denali Corporation. The logo consists of a stylized mountain graphic on the left, followed by the words "denali corporation" in a bold, sans-serif font. The mountain graphic appears to be a representation of Denali, also known as Mount McKinley, the highest peak in North America.
INDICATIONS FOR USE STATEMENT
510 (k) Number ____ (if known)
Device Name Clear Bravo
Indications for Use
Clear Bravo is a clear, light-cured pit and fissure sealant and sealer for application to the surfaces of teeth, sealing of composite margins and temporary restorations Clear Bravo Is available in either fluoride and non-fluoride releasing formulas
Please do not write below this line Continue on another page if needed
Concurrence of CDRH, Office of Device Evaluation (ODE)
"ision Sign-Off)
vision of Anesthesiology, General Hospital
infection Control, Dental Devices
510(k) Number FC83473
Prescription Use _x (Per 21 CFR 801 109) or
Over-The-Counter Use
§ 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.