Cleared Traditional

K033751 - AEGIS PIT & FISSURE SEALANT WITH ACP

K033751 is an FDA 510(k) clearance for AEGIS PIT & FISSURE SEALANT WITH ACP, manufactured by Harry J. Bosworth Co.. The device is a Class 2 Dental device with product code EBC cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K033751 · Harry J. Bosworth Co. · Dental device
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Feb 2004
Decision
66d
Days
Class 2
Risk

K033751 is an FDA 510(k) clearance for the AEGIS PIT & FISSURE SEALANT WITH ACP. Classified as Sealant, Pit And Fissure, And Conditioner (product code EBC), Class II - Special Controls.

Submitted by Harry J. Bosworth Co. (Skokie, US). The FDA issued a Cleared decision on February 5, 2004 after a review of 66 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 Harry J. Bosworth Co. devices

FDA 510(k) Submission Details - K033751

510(k) Number K033751 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2003
Decision Date February 05, 2004
Days to Decision 66 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 127d · This submission: 66d
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 102
Devices cleared under the same product code (EBC) and FDA review panel - the closest regulatory comparables to K033751.
RIVA PROTECT
K050871 · Southern Dental Industries, Inc. · Jun 2005
DELTON ILLUMINATING PIT AND FISSURE SEALING
K050959 · Dentsply International · May 2005
COSMEDENT PIT & FISSURE SEALANT
K042823 · Cosmedent, Inc. · Dec 2004
PIT & FISSURE SEALANT WITH FLUORIDE
K031811 · Harry J. Bosworth Co. · Sep 2003
ADMIRA SEAL
K021842 · Voco GmbH · Jul 2002
ADMIRA PROTECT
K021844 · Voco GmbH · Jul 2002