Cleared Traditional

AUTOMATIC PATIENT CHAIR PM2000 & A (K842359) - FDA 510(k) Clearance

K842359 · Planmeca USA, Inc. · Dental device
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Sep 1984
Decision
89d
Days
-
Risk

K842359 is an FDA 510(k) clearance for the AUTOMATIC PATIENT CHAIR PM2000 & A.

Submitted by Planmeca USA, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 19, 1984 after a review of 89 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 Planmeca USA, Inc. devices

Submission Details

510(k) Number K842359 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1984
Decision Date September 19, 1984
Days to Decision 89 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 127d · This submission: 89d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -