Cleared Traditional

K984013 - PLANMECA INTRACAM STATION

K984013 is the FDA 510(k) clearance for PLANMECA INTRACAM STATION by Planmeca Oy. It is a Class 1 Dental device (product code EIA) cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K984013 · Planmeca Oy · Dental device
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Jan 1999
Decision
76d
Days
Class 1
Risk

K984013 is an FDA 510(k) clearance for the PLANMECA INTRACAM STATION. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Planmeca Oy (Helsinki, FI). The FDA issued a Cleared decision on January 26, 1999 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - the FDA dental device regulatory framework. 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 Oy devices

Submission Details

510(k) Number K984013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 11, 1998
Decision Date January 26, 1999
Days to Decision 76 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 127d · This submission: 76d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EIA Unit, Operative Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6640
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EIA Unit, Operative Dental

All 61
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K984013.
ACUCAM CONCEPT IV, MODELS A1222B, A1223B, A1221B, A1121B, A1222C, A10402, A10403, A10401
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K981937 · Welch Allyn, Inc. · Aug 1998