Cleared Traditional

FOREMOST DENTIN ADHESIVE (K845033) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K845033 · Foremost Dental Mfg., Inc. · Dental device
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Mar 1985
Decision
81d
Days
Class 2
Risk

K845033 is an FDA 510(k) clearance for the FOREMOST DENTIN ADHESIVE. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Foremost Dental Mfg., Inc. (Englewood, US). The FDA issued a Cleared decision on March 18, 1985 after a review of 81 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 Foremost Dental Mfg., Inc. devices

Submission Details

510(k) Number K845033 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1984
Decision Date March 18, 1985
Days to Decision 81 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 127d · This submission: 81d
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 195
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K845033.
DISTALITE POSTERIA DENTAL RESTORATIVE
K852344 · Johnson & Johnson Professionals, Inc. · Jul 1985
VISILUX 2 VISIBLE LIGHT CURING UNIT
K851459 · 3M Company · May 1985
TRIAD C & B MATERIAL
K850911 · Dentsply Intl. · Apr 1985
SCOTCHBOND LIGHT CURED DENTAL ADHES
K841550 · 3M Company · Jun 1984
JOHNSON & JOHNSON POSTERIOR DENTAL (ADAPTIC II)
K841518 · Johnson & Johnson Professionals, Inc. · May 1984
LIGHT CURED RESIN BONDED CERAMIC
K833797 · 3M Company · Apr 1984