Cleared Traditional

K923157 - DENTAL RUBBER DAM

K923157 is an FDA 510(k) clearance for DENTAL RUBBER DAM, manufactured by Aseptico, Inc.. The device is a Class 1 Dental device with product code EIE cleared through the Traditional 510(k) pathway after a 388-day FDA review.

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

FDA 510(k) Submission Details - K923157

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
261d slower than avg
Panel avg: 127d · This submission: 388d
Pathway characteristics
Predicate-based equivalence.

EIE Device Classification - Class 1, General Controls

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.