Cleared Traditional

K771076 - ORTHODONTIC BRACKET ADHESIVE

K771076 is an FDA 510(k) clearance for ORTHODONTIC BRACKET ADHESIVE, manufactured by Lee Pharmaceuticals. The device is a Class 2 Dental device with product code DYH cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K771076 · Lee Pharmaceuticals · Dental device
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Jun 1977
Decision
9d
Days
Class 2
Risk

K771076 is an FDA 510(k) clearance for the ORTHODONTIC BRACKET ADHESIVE. Classified as Adhesive, Bracket And Tooth Conditioner, Resin (product code DYH), Class II - Special Controls.

Submitted by Lee Pharmaceuticals (Mchenry, US). The FDA issued a Cleared decision on June 24, 1977 after a review of 9 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 Lee Pharmaceuticals devices

FDA 510(k) Submission Details - K771076

510(k) Number K771076 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1977
Decision Date June 24, 1977
Days to Decision 9 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
118d faster than avg
Panel avg: 127d · This submission: 9d
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 148
Devices cleared under the same product code (DYH) and FDA review panel - the closest regulatory comparables to K771076.
SEAL & BOND DIRECT BONDING ORTHODONTIC
K790962 · Scientific Pharmaceuticals, Inc. · Jul 1979
ORTHODONTIC. PLASTIC BRACKET PRIMER
K780028 · 3M Company · Jan 1978
TEMP. BRIDGE, POSTERIOR 3-UNIT
K772126 · Lee Pharmaceuticals · Jan 1978
CEMENT, RESIN DENTAL (SOLO-TACH)
K760376 · L.D. Caulk Co. · Aug 1976
CEMENT, RESIN DENTAL (AUTO-TACH)
K760378 · L.D. Caulk Co. · Aug 1976