Cleared Traditional

K890740 - FRS LITE FLUORIDE RELEASING SEALANT

K890740 is the FDA 510(k) clearance for FRS LITE FLUORIDE RELEASING SEALANT by Ormco Corp.. It is a Class 2 Dental device (product code DYH) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K890740 · Ormco Corp. · Dental device
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Apr 1989
Decision
71d
Days
Class 2
Risk

K890740 is an FDA 510(k) clearance for the FRS LITE FLUORIDE RELEASING SEALANT. Classified as Adhesive, Bracket And Tooth Conditioner, Resin (product code DYH), Class II - Special Controls.

Submitted by Ormco Corp. (Glendora, US). The FDA issued a Cleared decision on April 25, 1989 after a review of 71 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 Ormco Corp. devices

Submission Details

510(k) Number K890740 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1989
Decision Date April 25, 1989
Days to Decision 71 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 127d · This submission: 71d
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 65
Devices cleared under the same product code (DYH) and FDA review panel - the closest regulatory comparables to K890740.
ADHESIVE, BRACKET AND TOOTH CONDITIONER RESIN
K921283 · Jeneric/Pentron, Inc. · Dec 1992
PULPDENT ORTHODONTIC BRACKET ADHESIVE
K911286 · Pulpdent Corp. · Jul 1991
NO-MIX 30 ORTHODONTIC BONDING SYSTEM, PLASTIC
K890834 · Scientific Pharmaceuticals, Inc. · May 1989
ORTHO-SEAL
K883465 · Bisco, Inc. · Oct 1988
ORMCO GEL-ETCH
K871591 · Scientific Pharmaceuticals, Inc. · May 1987
ACCLAIM* BRACKET ADHESIVE
K864008 · Johnson & Johnson Professionals, Inc. · Oct 1986