Cleared Traditional

DEN-MAT PAINT-ON RUBBER DAM (K852630) - FDA 510(k) Clearance

Class I Dental device.

K852630 · Den-Mat Corp. · Dental device
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Dec 1985
Decision
181d
Days
Class 1
Risk

K852630 is an FDA 510(k) clearance for the DEN-MAT PAINT-ON RUBBER DAM. Classified as Dam, Rubber (product code EIE), Class I - General Controls.

Submitted by Den-Mat Corp. (Santa Maria, US). The FDA issued a Cleared decision on December 18, 1985 after a review of 181 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6300 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Den-Mat Corp. devices

Submission Details

510(k) Number K852630 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 1985
Decision Date December 18, 1985
Days to Decision 181 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 127d · This submission: 181d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EIE Dam, Rubber
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6300
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.