Cleared Traditional

DENTIN ADHESIVE (K852024) - FDA 510(k) Clearance

K852024 · Dentsply Intl. · Dental device
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Jul 1985
Decision
82d
Days
-
Risk

K852024 is an FDA 510(k) clearance for the DENTIN ADHESIVE.

Submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on July 29, 1985 after a review of 82 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 K852024 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1985
Decision Date July 29, 1985
Days to Decision 82 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 127d · This submission: 82d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -