Cleared Traditional

REPLICA BONDING AGENT (K771881) - FDA 510(k) Clearance

K771881 · Hoyt Laboratories · Dental device
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Nov 1977
Decision
36d
Days
-
Risk

K771881 is an FDA 510(k) clearance for the REPLICA BONDING AGENT.

Submitted by Hoyt Laboratories (Mchenry, US). The FDA issued a Cleared decision on November 9, 1977 after a review of 36 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 K771881 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1977
Decision Date November 09, 1977
Days to Decision 36 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 127d · This submission: 36d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -