Cleared Traditional

K083473 - CLEAR BRAVO

K083473 is an FDA 510(k) clearance for CLEAR BRAVO, manufactured by Denali R&D Corporation. The device is a Class 2 Dental device with product code EBC cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K083473 · Denali R&D Corporation · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2009
Decision
59d
Days
Class 2
Risk

K083473 is an FDA 510(k) clearance for the CLEAR BRAVO. Classified as Sealant, Pit And Fissure, And Conditioner (product code EBC), Class II - Special Controls.

Submitted by Denali R&D Corporation (Hanover, US). The FDA issued a Cleared decision on January 22, 2009 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3765 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Denali R&D Corporation devices

FDA 510(k) Submission Details - K083473

510(k) Number K083473 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2008
Decision Date January 22, 2009
Days to Decision 59 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 127d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBC Device Classification - Class 2, Special Controls

Product Code EBC Sealant, Pit And Fissure, And Conditioner
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3765
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - EBC Sealant, Pit And Fissure, And Conditioner

All 98
Devices cleared under the same product code (EBC) and FDA review panel - the closest regulatory comparables to K083473.
ULTRASEAL ID
K101245 · Ultradent Products, Inc. · Sep 2010
INFILTRATION KIT
K100062 · Dmg USA, Inc. · Mar 2010
SPK SEALANT
K091632 · 3M Company · Sep 2009
INFILTRATION KIT
K081493 · Dmg USA, Inc. · Sep 2008
ASCENT PIT AND FISSURE SEALANT, MODEL 006-00019
K062886 · CAO Group, Inc. · Nov 2006
PREMIER SELF-ETCHING ENAMEL SEALANT
K061997 · Premier Dental Products Co. · Oct 2006