Cleared Traditional

K860971 - DEN-MAT GOLD LINK (FORMERLY DEN-MAT MET...

K860971 is the FDA 510(k) clearance for DEN-MAT GOLD LINK (FORMERLY DEN-MAT MET... by Den-Mat Corp.. It is a Class 2 Dental device (product code KLE) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K860971 · Den-Mat Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1986
Decision
21d
Days
Class 2
Risk

K860971 is an FDA 510(k) clearance for the DEN-MAT GOLD LINK (FORMERLY DEN-MAT METAL OPAQUER). Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Den-Mat Corp. (Santa Maria, US). The FDA issued a Cleared decision on March 25, 1986 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3200 - 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 K860971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1986
Decision Date March 25, 1986
Days to Decision 21 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 127d · This submission: 21d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KLE Agent, Tooth Bonding, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3200
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 - KLE Agent, Tooth Bonding, Resin

All 283
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K860971.
TEMPORARY DISCLOSING SOLUTION
K874074 · Dentsply Intl. · Dec 1987
MODIFIED SELF-CURE BONDING AGENT
K863522 · Dentsply Intl. · Sep 1986
KERR PORCELITE
K860346 · Kerr Corporation (Danbury) · Mar 1986
ETCH AND BOND
K852660 · Dentsply Intl. · Jul 1985
OPAQUER/BONDING AGENT
K851056 · Dentsply Intl. · Apr 1985
KERR PORCELAIN REPAIR PRIMER
K843023 · Kerr Corporation (Danbury) · Oct 1984