Cleared Traditional

K761276 - DENTAL STOOL (FDA 510(k) Clearance)

K761276 · Dentsply Intl. · Dental device
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Dec 1976
Decision
3d
Days
-
Risk

K761276 is an FDA 510(k) clearance for the DENTAL STOOL.

Submitted by Dentsply Intl. (Mchenry, US). The FDA issued a Cleared decision on December 23, 1976 after a review of 3 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.

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Submission Details

510(k) Number K761276 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1976
Decision Date December 23, 1976
Days to Decision 3 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
124d faster than avg
Panel avg: 127d · This submission: 3d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -