Cleared Traditional

K942992 - ROYAL SHIELD RUBBER DAMS

K942992 is an FDA 510(k) clearance for ROYAL SHIELD RUBBER DAMS, manufactured by Elastomade Accessories Sdn Bhd. The device is a Class 1 Dental device with product code EIE cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K942992 · Elastomade Accessories Sdn Bhd · Dental device
Download Printable Device Report (PDF)
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Sep 1994
Decision
93d
Days
Class 1
Risk

K942992 is an FDA 510(k) clearance for the ROYAL SHIELD RUBBER DAMS. Classified as Dam, Rubber (product code EIE), Class I - General Controls.

Submitted by Elastomade Accessories Sdn Bhd (Petaling Jaya, MY). The FDA issued a Cleared decision on September 21, 1994 after a review of 93 days - within the typical 510(k) review window.

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 Elastomade Accessories Sdn Bhd devices

FDA 510(k) Submission Details - K942992

510(k) Number K942992 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 1994
Decision Date September 21, 1994
Days to Decision 93 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
34d faster than avg
Panel avg: 127d · This submission: 93d
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.