Cleared Traditional

DISC, WILL-CERUM LIQUID (K760514) - FDA 510(k) Clearance

K760514 · Williams Gold Refining Co., Inc. · Dental device
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Sep 1976
Decision
9d
Days
-
Risk

K760514 is an FDA 510(k) clearance for the DISC, WILL-CERUM LIQUID.

Submitted by Williams Gold Refining Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on September 3, 1976 after a review of 9 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Williams Gold Refining Co., Inc. devices

Submission Details

510(k) Number K760514 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1976
Decision Date September 03, 1976
Days to Decision 9 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 127d · This submission: 9d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -