Cleared Traditional

K861899 - SCOTCHBOND LIGHT CURED DENTAL ADHESIVE W/FLUORIDE

K861899 is an FDA 510(k) clearance for SCOTCHBOND LIGHT CURED DENTAL ADHESIVE ..., manufactured by 3M Company. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K861899 · 3M Company · Dental device
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Jun 1986
Decision
40d
Days
Class 2
Risk

K861899 is an FDA 510(k) clearance for the SCOTCHBOND LIGHT CURED DENTAL ADHESIVE W/FLUORIDE. 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 June 25, 1986 after a review of 40 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

FDA 510(k) Submission Details - K861899

510(k) Number K861899 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1986
Decision Date June 25, 1986
Days to Decision 40 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
87d faster than avg
Panel avg: 127d · This submission: 40d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBF Device Classification - Class 2, Special Controls

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 798
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K861899.
DEN-MAT DENTIN LINK
K862449 · Den-Mat Corp. · Jul 1986
V-BOND, PAINT-ON COMPOSITE RESTOR/VENEER CEMENT
K862648 · Scientific Pharmaceuticals, Inc. · Jul 1986
RESTOR (COMET)*DENTAL RESTORATIVE
K861833 · Johnson & Johnson Professionals, Inc. · Jul 1986
P-50 LIGHT CURED RESIN BONDED CERAMIC
K861740 · 3M Company · May 1986
BISCO'S PORCELAIN VENEER SYSTEM
K861148 · Bisco, Inc. · Apr 1986
PHOTO CLEARFIL OPAQUER
K860708 · Kuraray Co. · Apr 1986