Cleared Traditional

K840652 - PRISM-FINE (FDA 510(k) Clearance)

K840652 · Dentsply Intl. · Dental device
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Aug 1984
Decision
169d
Days
-
Risk

K840652 is an FDA 510(k) clearance for the PRISM-FINE.

Submitted by Dentsply Intl. (Mchenry, US). The FDA issued a Cleared decision on August 2, 1984 after a review of 169 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Dentsply Intl. devices

Submission Details

510(k) Number K840652 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 1984
Decision Date August 02, 1984
Days to Decision 169 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 127d · This submission: 169d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -