Cleared Traditional

K872279 - SCOTCHBOND 2 ADHESIVE W/SCOTCHPREP DENT...

K872279 is the FDA 510(k) clearance for SCOTCHBOND 2 ADHESIVE W/SCOTCHPREP DENT... by 3M Company. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K872279 · 3M Company · Dental device
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Jul 1987
Decision
17d
Days
Class 2
Risk

K872279 is an FDA 510(k) clearance for the SCOTCHBOND 2 ADHESIVE W/SCOTCHPREP DENTIN PRIMER. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by 3M Company (Cottae Grove, US). The FDA issued a Cleared decision on July 2, 1987 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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

Submission Details

510(k) Number K872279 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1987
Decision Date July 02, 1987
Days to Decision 17 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
110d faster than avg
Panel avg: 127d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 - EBF Material, Tooth Shade, Resin

All 545
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K872279.
IMPERVA-P
K871898 · Shofu Dental Corp. · Jul 1987
IMPERVA-A
K871899 · Shofu Dental Corp. · Jul 1987
TEMREX ETCHING GEL
K872569 · Scientific Pharmaceuticals, Inc. · Jul 1987
ADAPTALITE* PORCELAIN VENEER CEMENTATION SYSTEM
K871295 · Johnson & Johnson Professionals, Inc. · May 1987
ESPE CHELON-SILVER
K865028 · Espe GmbH (Us) · Feb 1987
RECOVER
K863401 · Scientific Pharmaceuticals, Inc. · Nov 1986