Cleared Traditional

K780028 - ORTHODONTIC. PLASTIC BRACKET PRIMER

K780028 is an FDA 510(k) clearance for ORTHODONTIC. PLASTIC BRACKET PRIMER, manufactured by 3M Company. The device is a Class 2 Dental device with product code DYH cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K780028 · 3M Company · Dental device
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Jan 1978
Decision
11d
Days
Class 2
Risk

K780028 is an FDA 510(k) clearance for the ORTHODONTIC. PLASTIC BRACKET PRIMER. Classified as Adhesive, Bracket And Tooth Conditioner, Resin (product code DYH), Class II - Special Controls.

Submitted by 3M Company (White City, US). The FDA issued a Cleared decision on January 17, 1978 after a review of 11 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 3M Company devices

FDA 510(k) Submission Details - K780028

510(k) Number K780028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1978
Decision Date January 17, 1978
Days to Decision 11 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
116d faster than avg
Panel avg: 127d · This submission: 11d
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 141
Devices cleared under the same product code (DYH) and FDA review panel - the closest regulatory comparables to K780028.
INSTA-BOND
K810517 · Lee Pharmaceuticals · Mar 1981
SCI-PHARM ORTHODONTIC ADHESIVE
K791132 · Scientific Pharmaceuticals, Inc. · Aug 1979
SEAL & BOND DIRECT BONDING ORTHODONTIC
K790962 · Scientific Pharmaceuticals, Inc. · Jul 1979
TEMP. BRIDGE, POSTERIOR 3-UNIT
K772126 · Lee Pharmaceuticals · Jan 1978
ORTHODONTIC BRACKET ADHESIVE
K771076 · Lee Pharmaceuticals · Jun 1977
CEMENT, RESIN DENTAL (SOLO-TACH)
K760376 · L.D. Caulk Co. · Aug 1976