Cleared Traditional

K800133 - PANOREX II DENTAL X-RAY UNIT

K800133 is an FDA 510(k) clearance for PANOREX II DENTAL X-RAY UNIT, manufactured by Pennwalt Corp.. The device is a Class 2 Radiology device with product code EHD cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K800133 · Pennwalt Corp. · Radiology device
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Mar 1980
Decision
42d
Days
Class 2
Risk

K800133 is an FDA 510(k) clearance for the PANOREX II DENTAL X-RAY UNIT. Classified as Unit, X-ray, Extraoral With Timer (product code EHD), Class II - Special Controls.

Submitted by Pennwalt Corp. (Mchenry, US). The FDA issued a Cleared decision on March 3, 1980 after a review of 42 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 Pennwalt Corp. devices

FDA 510(k) Submission Details - K800133

510(k) Number K800133 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1980
Decision Date March 03, 1980
Days to Decision 42 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 107d · This submission: 42d
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 151
Devices cleared under the same product code (EHD) and FDA review panel - the closest regulatory comparables to K800133.
ORTHOPANTOMOGRAPH 100
K912893 · Instrumentarium Corp. · Nov 1991
ORTHOPHOS AND ORTHOPHOS C
K895467 · Siemens Medical Solutions USA, Inc. · Nov 1989
GE 900
K811103 · General Electric Co. · Jun 1981
GENERAL ELECTRIC PANELIPSE LD
K792581 · General Electric Co. · Jan 1980
DENTAL X-RAY UNIT
K781286 · Siemens Corp. · Sep 1978
DENTAL X-RAY UNIT HELIODENT 70
K781288 · Siemens Corp. · Sep 1978