Cleared Traditional

MINIDAM II (K921771) - FDA 510(k) Clearance

Class I Dental device.

K921771 · Delsan Dental Systems · Dental device
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Sep 1992
Decision
157d
Days
Class 1
Risk

K921771 is an FDA 510(k) clearance for the MINIDAM II. Classified as Dam, Rubber (product code EIE), Class I - General Controls.

Submitted by Delsan Dental Systems (Pennington, US). The FDA issued a Cleared decision on September 17, 1992 after a review of 157 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 Delsan Dental Systems devices

Submission Details

510(k) Number K921771 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1992
Decision Date September 17, 1992
Days to Decision 157 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 127d · This submission: 157d
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.