Cleared Traditional

K872907 - DENTIN ADHESIVE

K872907 is an FDA 510(k) clearance for DENTIN ADHESIVE, manufactured by Dentsply Intl.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K872907 · Dentsply Intl. · Dental device
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Aug 1987
Decision
10d
Days
Class 2
Risk

K872907 is an FDA 510(k) clearance for the DENTIN ADHESIVE. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on August 3, 1987 after a review of 10 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 Dentsply Intl. devices

FDA 510(k) Submission Details - K872907

510(k) Number K872907 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1987
Decision Date August 03, 1987
Days to Decision 10 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
117d faster than avg
Panel avg: 127d · This submission: 10d
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 800
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K872907.
DEN-MAT TENURE
K872510 · Den-Mat Corp. · Aug 1987
CLEARFIL POSTERIOR NEW BOND
K872960 · Kuraray Co. · Aug 1987
SYNERGY
K872890 · Scientific Pharmaceuticals, Inc. · Aug 1987
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