Cleared Traditional

K862449 - DEN-MAT DENTIN LINK

K862449 is the FDA 510(k) clearance for DEN-MAT DENTIN LINK by Den-Mat Corp.. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K862449 · Den-Mat Corp. · Dental device
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Jul 1986
Decision
25d
Days
Class 2
Risk

K862449 is an FDA 510(k) clearance for the DEN-MAT DENTIN LINK. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Den-Mat Corp. (Santa Maria, US). The FDA issued a Cleared decision on July 22, 1986 after a review of 25 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 Den-Mat Corp. devices

Submission Details

510(k) Number K862449 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 1986
Decision Date July 22, 1986
Days to Decision 25 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 127d · This submission: 25d
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 578
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K862449.
MULTIFIL(R) VS
K863315 · Kulzer, Inc. · Sep 1986
DENTAL COMPOSITE RESTORATIVE
K863092 · Dentsply Intl. · Sep 1986
ESPE VISIO-MOLAR
K862292 · Espe GmbH (Us) · Aug 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
SCOTCHBOND LIGHT CURED DENTAL ADHESIVE W/FLUORIDE
K861899 · 3M Company · Jun 1986