Cleared Traditional

K923157 - DENTAL RUBBER DAM (FDA 510(k) Clearance)

Class I Dental device.

K923157 · Aseptico, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1993
Decision
388d
Days
Class 1
Risk

K923157 is an FDA 510(k) clearance for the DENTAL RUBBER DAM. Classified as Dam, Rubber (product code EIE), Class I - General Controls.

Submitted by Aseptico, Inc. (Kirkland, US). The FDA issued a Cleared decision on July 22, 1993 after a review of 388 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Aseptico, Inc. devices

Submission Details

510(k) Number K923157 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 1992
Decision Date July 22, 1993
Days to Decision 388 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
261d slower than avg
Panel avg: 127d · This submission: 388d
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.