Cleared Traditional

K901236 - RUBBER, DENTAL DAM (NON-STERILE)

K901236 is an FDA 510(k) clearance for RUBBER, manufactured by Naturub Sdn. Bhd.. The device is a Class 1 Dental device with product code EIE cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K901236 · Naturub Sdn. Bhd. · Dental device
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Jun 1990
Decision
83d
Days
Class 1
Risk

K901236 is an FDA 510(k) clearance for the RUBBER, DENTAL DAM (NON-STERILE). Classified as Dam, Rubber (product code EIE), Class I - General Controls.

Submitted by Naturub Sdn. Bhd. (Malaysia, MY). The FDA issued a Cleared decision on June 6, 1990 after a review of 83 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Naturub Sdn. Bhd. devices

FDA 510(k) Submission Details - K901236

510(k) Number K901236 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1990
Decision Date June 06, 1990
Days to Decision 83 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 127d · This submission: 83d
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.