Cleared Traditional

K933455 - COMPUTED ORAL RADIOLOGY SYSTEM

K933455 is an FDA 510(k) clearance for COMPUTED ORAL RADIOLOGY SYSTEM, manufactured by Schick Technologies, Inc.. The device is a Class 2 Radiology device with product code EAP cleared through the Traditional 510(k) pathway after a 201-day FDA review.

K933455 · Schick Technologies, Inc. · Radiology device
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Jan 1994
Decision
201d
Days
Class 2
Risk

K933455 is an FDA 510(k) clearance for the COMPUTED ORAL RADIOLOGY SYSTEM. Classified as Unit, X-ray, Intraoral (product code EAP), Class II - Special Controls.

Submitted by Schick Technologies, Inc. (Sound Beach, US). The FDA issued a Cleared decision on January 31, 1994 after a review of 201 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 872.1810 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K933455

510(k) Number K933455 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1993
Decision Date January 31, 1994
Days to Decision 201 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 slower than avg
Panel avg: 107d · This submission: 201d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EAP Device Classification - Class 2, Special Controls

Product Code EAP Unit, X-ray, Intraoral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1810
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 - EAP Unit, X-ray, Intraoral

All 29
Devices cleared under the same product code (EAP) and FDA review panel - the closest regulatory comparables to K933455.
HELIODENT MD
K950030 · Pelton & Crane Co. · Feb 1995
RADWORKS
K934645 · Radworks Corp. · Aug 1994
ORTHOPHOS 3/ ORTHOPHOS 3C
K936068 · Pelton & Crane Co. · Jul 1994
INTREX VSK INTERORAL DENTAL X-RAY UNIT
K931486 · Keystone X-Ray, Inc. · Nov 1993
YOSHIDA/KAYCOR X-707 WALL MOUNTED DENTAL X-RAY
K931717 · Kaycor Intl., Ltd. · Sep 1993
INTREX INTERORAL DENTAL X-RAY UNIT
K930925 · Keystone X-Ray, Inc. · Jul 1993
K933455 · COMPUTED ORAL RADIOLOGY SYSTEM
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