Cleared Traditional

K871591 - ORMCO GEL-ETCH

K871591 is the FDA 510(k) clearance for ORMCO GEL-ETCH by Scientific Pharmaceuticals, Inc.. It is a Class 2 Dental device (product code DYH) cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K871591 · Scientific Pharmaceuticals, Inc. · Dental device
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May 1987
Decision
24d
Days
Class 2
Risk

K871591 is an FDA 510(k) clearance for the ORMCO GEL-ETCH. Classified as Adhesive, Bracket And Tooth Conditioner, Resin (product code DYH), Class II - Special Controls.

Submitted by Scientific Pharmaceuticals, Inc. (Duarte, US). The FDA issued a Cleared decision on May 18, 1987 after a review of 24 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 Scientific Pharmaceuticals, Inc. devices

Submission Details

510(k) Number K871591 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1987
Decision Date May 18, 1987
Days to Decision 24 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 127d · This submission: 24d
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 115
Devices cleared under the same product code (DYH) and FDA review panel - the closest regulatory comparables to K871591.
EXCEL REGULAR SET
K875141 · Reliance Orthodontic Products, Inc. · Feb 1988
RELY-A-BOND(NO MIX ORTHODONTIC ADHESIVE)
K875143 · Reliance Orthodontic Products, Inc. · Feb 1988
EXCEL FAST SET
K875144 · Reliance Orthodontic Products, Inc. · Feb 1988
CHALLENGE ORTHODONTIC BONDING ADHESIVE
K863709 · Ormco Corp. · Jan 1987
ACCLAIM* BRACKET ADHESIVE
K864008 · Johnson & Johnson Professionals, Inc. · Oct 1986
ESPE NIMETIC-GRIP
K844844 · Espe GmbH (Us) · Feb 1986