Cleared Traditional

K970104 - SANI-SHIELD

K970104 is an FDA 510(k) clearance for SANI-SHIELD, manufactured by Dw Industries, Inc.. The device is a Class 1 Dental device with product code EFB cleared through the Traditional 510(k) pathway after a 113-day FDA review.

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

FDA 510(k) Submission Details - K970104

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 127d · This submission: 113d
Pathway characteristics
Predicate-based equivalence.

EFB Device Classification - Class 1, General Controls

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 103
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K970104.
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