Cleared Traditional

K950857 - FORAMATRON IV

K950857 · Parkell, Inc. · Dental device
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Apr 1995
Decision
52d
Days
-
Risk

K950857 is an FDA 510(k) clearance for the FORAMATRON IV. Classified as Locator, Root Apex (product code LQY).

Submitted by Parkell, Inc. (Farmingdale, US). The FDA issued a Cleared decision on April 20, 1995 after a review of 52 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 Parkell, Inc. devices

Submission Details

510(k) Number K950857 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1995
Decision Date April 20, 1995
Days to Decision 52 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 127d · This submission: 52d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LQY Locator, Root Apex
Device Class -