Cleared Traditional

K961472 - DENTAL DAM SILICONE (FDA 510(k) Clearance)

Class I Dental device.

K961472 · Worldwide Dental, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1996
Decision
112d
Days
Class 1
Risk

K961472 is an FDA 510(k) clearance for the DENTAL DAM SILICONE. Classified as Dam, Rubber (product code EIE), Class I - General Controls.

Submitted by Worldwide Dental, Inc. (Concord, US). The FDA issued a Cleared decision on August 7, 1996 after a review of 112 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 Worldwide Dental, Inc. devices

Submission Details

510(k) Number K961472 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1996
Decision Date August 07, 1996
Days to Decision 112 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
15d faster than avg
Panel avg: 127d · This submission: 112d
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.