Cleared Traditional

K972033 - PLANMECA INTRACAM

K972033 is the FDA 510(k) clearance for PLANMECA INTRACAM by Planmeca Oy. It is a Class 1 Dental device (product code EIA) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K972033 · Planmeca Oy · Dental device
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Jun 1997
Decision
18d
Days
Class 1
Risk

K972033 is an FDA 510(k) clearance for the PLANMECA INTRACAM. 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 June 20, 1997 after a review of 18 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 K972033 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1997
Decision Date June 20, 1997
Days to Decision 18 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
109d faster than avg
Panel avg: 127d · This submission: 18d
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 K972033.
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K940893 · A-Dec, Inc. · Jul 1994