Cleared Traditional

K040548 - AEGIS ORTHO LIGHT-CURED ORTHODONTIC ADH...

K040548 is the FDA 510(k) clearance for AEGIS ORTHO LIGHT-CURED ORTHODONTIC ADH... by Harry J. Bosworth Co.. It is a Class 2 Dental device (product code DYH) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K040548 · Harry J. Bosworth Co. · Dental device
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Mar 2004
Decision
17d
Days
Class 2
Risk

K040548 is an FDA 510(k) clearance for the AEGIS ORTHO LIGHT-CURED ORTHODONTIC ADHESIVE. Classified as Adhesive, Bracket And Tooth Conditioner, Resin (product code DYH), Class II - Special Controls.

Submitted by Harry J. Bosworth Co. (Skokie, US). The FDA issued a Cleared decision on March 19, 2004 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3750 - 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

Submission Details

510(k) Number K040548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2004
Decision Date March 19, 2004
Days to Decision 17 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
110d faster than avg
Panel avg: 127d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DYH Adhesive, Bracket And Tooth Conditioner, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3750
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 - DYH Adhesive, Bracket And Tooth Conditioner, Resin

All 67
Devices cleared under the same product code (DYH) and FDA review panel - the closest regulatory comparables to K040548.
D3 CHROMA
K042422 · Sybron Dental Specialties, Inc. · Nov 2004
IDEAL 1 ORTHODONTIC BAND CEMENT
K040375 · Dentsply Intl. · Apr 2004
AEGIS ORTHO DUAL-CURED ORTHODONTIC ADHESIVE
K040547 · Harry J. Bosworth Co. · Mar 2004
IDEAL 1 ORTHODONTIC BRACKET ADHESIVE
K033703 · Dentsply Intl. · Feb 2004
OPTIBAND LC
K032407 · Sybron Dental Specialties, Inc. · Oct 2003
ENVISION
K032042 · Sybron Dental Specialties, Inc. · Sep 2003