Cleared Traditional

K803269 - CAPSULE DENTAL AMALGAM (FDA 510(k) Clearance)

K803269 · Dentsply Intl. · Dental device
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Jan 1981
Decision
17d
Days
-
Risk

K803269 is an FDA 510(k) clearance for the CAPSULE DENTAL AMALGAM.

Submitted by Dentsply Intl. (Mchenry, US). The FDA issued a Cleared decision on January 15, 1981 after a review of 17 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 Dentsply Intl. devices

Submission Details

510(k) Number K803269 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1980
Decision Date January 15, 1981
Days to Decision 17 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 127d · This submission: 17d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -