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K Number
K083473
Device Name
CLEAR BRAVO
Manufacturer
DENALI R&D CORPORATION
Date Cleared
2009-01-22

(59 days)

Product Code
EBC
Regulation Number
872.3765
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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 Description

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

AI/ML Overview

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.

§ 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.