Cleared Traditional

DENTSPLY DIE STONE (K761067) - FDA 510(k) Clearance

K761067 · Ransom and Randolph · Dental device
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Nov 1976
Decision
12d
Days
-
Risk

K761067 is an FDA 510(k) clearance for the DENTSPLY DIE STONE.

Submitted by Ransom and Randolph (Mchenry, US). The FDA issued a Cleared decision on November 30, 1976 after a review of 12 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 Ransom and Randolph devices

Submission Details

510(k) Number K761067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1976
Decision Date November 30, 1976
Days to Decision 12 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 127d · This submission: 12d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -