Cleared Traditional

K984013 - PLANMECA INTRACAM STATION

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

K984013 · Planmeca Oy · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K984013

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 127d · This submission: 76d
Pathway characteristics
Predicate-based equivalence.

EIA Device Classification - Class 1, General Controls

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 171
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K984013.
AIR TECHNIQUES' DENTO-VAC
K984584 · Air Techniques, Inc. · Mar 1999
SCICAN CLASSIC
K984556 · Scholly Fiberoptic GmbH · Feb 1999
ADEC DENTAL UNIT, MODELS CENTURY PLUS & CASCADE, DCI DENTAL UNIT, MODEL SERIES III
K984609 · Lite Specialty Metal Works, Inc. · Feb 1999
OPTUM, INTRAORAL CAMERA SYSTEM
K983739 · Camsight, Inc. · Jan 1999
BELMONT UNIT, MODEL 6000 SERIES AND 7500 SERIES
K983661 · Belmont Equipment Corp. · Jan 1999
S555 INTRAORAL DENTAL CAMERA
K983625 · Sopro · Jan 1999