Cleared Traditional

SANI-SHIELD (K970104) - FDA 510(k) Clearance

Class I Dental device.

K970104 · Dw Industries, Inc. · Dental device
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May 1997
Decision
113d
Days
Class 1
Risk

K970104 is an FDA 510(k) clearance for the SANI-SHIELD. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Dw Industries, Inc. (Washington, US). The FDA issued a Cleared decision on May 6, 1997 after a review of 113 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - 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 Dw Industries, Inc. devices

Submission Details

510(k) Number K970104 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1997
Decision Date May 06, 1997
Days to Decision 113 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 127d · This submission: 113d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFB Handpiece, Air-powered, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
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 - EFB Handpiece, Air-powered, Dental

All 37
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K970104.
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