Cleared Traditional

K904090 - ORTHODONTIC BONDING ADHESIVE CONTROL

K904090 is an FDA 510(k) clearance for ORTHODONTIC BONDING ADHESIVE CONTROL, manufactured by Lancer Orthodontics, Inc.. The device is a Class 2 Dental device with product code DYH cleared through the Traditional 510(k) pathway after a 235-day FDA review.

K904090 · Lancer Orthodontics, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1991
Decision
235d
Days
Class 2
Risk

K904090 is an FDA 510(k) clearance for the ORTHODONTIC BONDING ADHESIVE CONTROL. Classified as Adhesive, Bracket And Tooth Conditioner, Resin (product code DYH), Class II - Special Controls.

Submitted by Lancer Orthodontics, Inc. (Carlsbad, US). The FDA issued a Cleared decision on April 29, 1991 after a review of 235 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Lancer Orthodontics, Inc. devices

FDA 510(k) Submission Details - K904090

510(k) Number K904090 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1990
Decision Date April 29, 1991
Days to Decision 235 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d slower than avg
Panel avg: 127d · This submission: 235d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYH Device Classification - Class 2, Special Controls

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 142
Devices cleared under the same product code (DYH) and FDA review panel - the closest regulatory comparables to K904090.
SEQUENCE LIGHT CURE ADHESIVE
K914727 · Ormco Corp. · Jan 1992
PULPDENT ORTHODONTIC BRACKET ADHESIVE
K911286 · Pulpdent Corp. · Jul 1991
ADHESIVE PRECOATED BRACKETS
K911271 · Unitek Corp. · May 1991
PHASE II ORTHODONTIC ADHESIVE
K895523 · Reliance Orthodontic Products, Inc. · Dec 1989
RELY-A-BOND W/FLUORIDE (NO MIX ADHESIVE)
K895521 · Reliance Orthodontic Products, Inc. · Dec 1989
LIGHT BOND PASTE W/FLUORIDE
K895522 · Reliance Orthodontic Products, Inc. · Dec 1989