Cleared Traditional

K910803 - ENAMEL ETCHING GEL

K910803 is an FDA 510(k) clearance for ENAMEL ETCHING GEL, manufactured by Gresco Products, Inc.. The device is a Class 2 Dental device with product code DYH cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K910803 · Gresco Products, Inc. · Dental device
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Mar 1991
Decision
17d
Days
Class 2
Risk

K910803 is an FDA 510(k) clearance for the ENAMEL ETCHING GEL. Classified as Adhesive, Bracket And Tooth Conditioner, Resin (product code DYH), Class II - Special Controls.

Submitted by Gresco Products, Inc. (Stafford, US). The FDA issued a Cleared decision on March 15, 1991 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 Gresco Products, Inc. devices

FDA 510(k) Submission Details - K910803

510(k) Number K910803 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1991
Decision Date March 15, 1991
Days to Decision 17 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
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.

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 135
Devices cleared under the same product code (DYH) and FDA review panel - the closest regulatory comparables to K910803.
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