Cleared Traditional

DIFFERENTIA/DIAGNOSTIC OCCLUSA/APPLIANC (K831344) - FDA 510(k) Clearance

K831344 · Brimms, Inc. · Dental device
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Jul 1983
Decision
84d
Days
-
Risk

K831344 is an FDA 510(k) clearance for the DIFFERENTIA/DIAGNOSTIC OCCLUSA/APPLIANC.

Submitted by Brimms, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 18, 1983 after a review of 84 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 Brimms, Inc. devices

Submission Details

510(k) Number K831344 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1983
Decision Date July 18, 1983
Days to Decision 84 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 127d · This submission: 84d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -