Cleared Traditional

SURETIP SYRINGE TIP COVER (K931772) - FDA 510(k) Clearance

Class I Dental device.

K931772 · Western M/D, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
332d
Days
Class 1
Risk

K931772 is an FDA 510(k) clearance for the SURETIP SYRINGE TIP COVER. Classified as Unit, Syringe, Air And/or Water (product code ECB), Class I - General Controls.

Submitted by Western M/D, Inc. (Burlingame, US). The FDA issued a Cleared decision on March 7, 1994 after a review of 332 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Western M/D, Inc. devices

Submission Details

510(k) Number K931772 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1993
Decision Date March 07, 1994
Days to Decision 332 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
205d slower than avg
Panel avg: 127d · This submission: 332d
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.