CLEAR BRAVO

K083473 · Denali R&D Corporation · EBC · Jan 22, 2009 · Dental

Device Facts

• Record ID: K083473
• Device Name: CLEAR BRAVO
• Applicant: Denali R&D Corporation
• Product Code: EBC · Dental
• Decision Date: Jan 22, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3765
• Device Class: Class 2
• Attributes: Therapeutic

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 available in either fluoride and non-fluoride releasing formulas

Device Story

Clear Bravo is a light-cured dental sealant used by dental professionals to seal tooth surfaces, composite margins, and temporary restorations. The device is applied to the tooth and cured using a dental light source. Its crystal-clear formulation allows clinicians to monitor the underlying tooth condition for leakage or staining and facilitates the use of caries-detecting devices. It is available in both fluoride-releasing and non-fluoride-releasing formulas. The device is intended for use in a clinical dental setting.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, composition, and intended use comparisons to legally marketed predicate devices.

Technological Characteristics

Light-cured pit and fissure sealant; available in fluoride and non-fluoride releasing formulas; clear/transparent formulation; Class II dental device (21 CFR 872.3765).

Indications for Use

Indicated for application to tooth surfaces, sealing of composite margins, and sealing of temporary restorations in patients requiring pit and fissure sealants.

Regulatory Classification

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.

Predicate Devices

• CosmeSeal Pit and Fissure Sealant
• UltraSeal XT Pit and Fissure Sealant and Flowable Composite Kit
• Delton Clear Pit and Fissure Sealant Kit

Submission Summary (Full Text)

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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 [phone] 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 [phone] 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 [phone] or [phone] 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