Cleared Traditional

K874074 - TEMPORARY DISCLOSING SOLUTION

K874074 is the FDA 510(k) clearance for TEMPORARY DISCLOSING SOLUTION by Dentsply Intl.. It is a Class 2 Dental device (product code KLE) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K874074 · Dentsply Intl. · Dental device
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Dec 1987
Decision
84d
Days
Class 2
Risk

K874074 is an FDA 510(k) clearance for the TEMPORARY DISCLOSING SOLUTION. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on December 29, 1987 after a review of 84 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 Dentsply Intl. devices

Submission Details

510(k) Number K874074 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1987
Decision Date December 29, 1987
Days to Decision 84 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
43d faster than avg
Panel avg: 127d · This submission: 84d
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 290
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K874074.
DENTIN PRIMER
K891455 · Dentsply Intl. · May 1989
KETAC-GLAZE
K884752 · Espe GmbH (Us) · Jan 1989
XR PRIMER
K880684 · Kerr Corporation (Danbury) · May 1988
MODIFIED SELF-CURE BONDING AGENT
K863522 · Dentsply Intl. · Sep 1986
KERR PORCELITE
K860346 · Kerr Corporation (Danbury) · Mar 1986
DEN-MAT GOLD LINK (FORMERLY DEN-MAT METAL OPAQUER)
K860971 · Den-Mat Corp. · Mar 1986