Cleared Traditional

K923163 - RUBBER DAM CLAMP

K923163 is an FDA 510(k) clearance for RUBBER DAM CLAMP, 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 182-day FDA review.

K923163 · Aseptico, Inc. · Dental device
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Dec 1992
Decision
182d
Days
Class 1
Risk

K923163 is an FDA 510(k) clearance for the RUBBER DAM CLAMP. Classified as Dam, Rubber (product code EIE), Class I - General Controls.

Submitted by Aseptico, Inc. (Kirkland, US). The FDA issued a Cleared decision on December 28, 1992 after a review of 182 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.

FDA 510(k) Submission Details - K923163

510(k) Number K923163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 1992
Decision Date December 28, 1992
Days to Decision 182 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 128d · This submission: 182d
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.

Regulatory Peers - EIE Dam, Rubber

All 28
Devices cleared under the same product code (EIE) and FDA review panel - the closest regulatory comparables to K923163.
ROYAL SHIELD NON-STERILE POWDER-FREE RUBBER DAMS
K952628 · Elastomade Accessories Sdn Bhd · Oct 1995
ROYAL SHIELD RUBBER DAMS
K942992 · Elastomade Accessories Sdn Bhd · Sep 1994
DENTAL RUBBER DAM
K923157 · Aseptico, Inc. · Jul 1993
MINIDAM II
K921771 · Delsan Dental Systems · Sep 1992
STANDARD RUBBER DAM WITH OR WITHOUT FRAMES
K905470 · Elastomade Accessories Sdn Bhd · Apr 1991
RUBBER, DENTAL DAM (NON-STERILE)
K901236 · Naturub Sdn. Bhd. · Jun 1990
K923163 · RUBBER DAM CLAMP
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