Cleared Traditional

K955429 - PROSTYLE INTRA

K955429 is an FDA 510(k) clearance for PROSTYLE INTRA, manufactured by Planmeca Oy. The device is a Class 2 Radiology device with product code EHD cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K955429 · Planmeca Oy · Radiology device
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Dec 1995
Decision
13d
Days
Class 2
Risk

K955429 is an FDA 510(k) clearance for the PROSTYLE INTRA. Classified as Unit, X-ray, Extraoral With Timer (product code EHD), Class II - Special Controls.

Submitted by Planmeca Oy (Helsinki, FI). The FDA issued a Cleared decision on December 11, 1995 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 872.1800 - the FDA radiology and imaging software oversight 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 - K955429

510(k) Number K955429 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1995
Decision Date December 11, 1995
Days to Decision 13 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 107d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EHD Device Classification - Class 2, Special Controls

Product Code EHD Unit, X-ray, Extraoral With Timer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1800
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - EHD Unit, X-ray, Extraoral With Timer

All 78
Devices cleared under the same product code (EHD) and FDA review panel - the closest regulatory comparables to K955429.
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