Cleared Traditional

SANI-TIP (K920499) - FDA 510(k) Clearance

Class I Dental device.

K920499 · Dw Industries, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1992
Decision
90d
Days
Class 1
Risk

K920499 is an FDA 510(k) clearance for the SANI-TIP. Classified as Unit, Syringe, Air And/or Water (product code ECB), Class I - General Controls.

Submitted by Dw Industries, Inc. (Washington, US). The FDA issued a Cleared decision on May 3, 1992 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4565 - 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 K920499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1992
Decision Date May 03, 1992
Days to Decision 90 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
37d faster than avg
Panel avg: 127d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ECB Unit, Syringe, Air And/or Water
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4565
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.