Cleared Traditional

K053089 - ASCENT PIT & FISSURE SEALANT

K053089 is the FDA 510(k) clearance for ASCENT PIT & FISSURE SEALANT by CAO Group, Inc.. It is a Class 2 Dental device (product code EBC) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K053089 · CAO Group, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2005
Decision
48d
Days
Class 2
Risk

K053089 is an FDA 510(k) clearance for the ASCENT PIT & FISSURE SEALANT. Classified as Sealant, Pit And Fissure, And Conditioner (product code EBC), Class II - Special Controls.

Submitted by CAO Group, Inc. (Sandy, US). The FDA issued a Cleared decision on December 20, 2005 after a review of 48 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 CAO Group, Inc. devices

Submission Details

510(k) Number K053089 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2005
Decision Date December 20, 2005
Days to Decision 48 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
79d faster than avg
Panel avg: 127d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 63
Devices cleared under the same product code (EBC) and FDA review panel - the closest regulatory comparables to K053089.
PREMIER SELF-ETCHING ENAMEL SEALANT
K061997 · Premier Dental Products Co. · Oct 2006
GRANDIO SEAL
K062344 · Voco GmbH · Oct 2006
ADMIRA PROTECT/ADMIRA PROTECT SINGLE DOSE
K061823 · Voco GmbH · Jul 2006
BOSWORTH SEAL
K051224 · Harry J. Bosworth Co. · Jul 2005
AEGIS PIT & FISSURE SEALANT WITH ACP
K033751 · Harry J. Bosworth Co. · Feb 2004
PIT & FISSURE SEALANT WITH FLUORIDE
K031811 · Harry J. Bosworth Co. · Sep 2003