Cleared Traditional

K896963 - TRIMODE SP DENTAL INTRA ORAL X-RAY

K896963 is an FDA 510(k) clearance for TRIMODE SP DENTAL INTRA ORAL X-RAY, manufactured by Tempo Technology, Inc.. The device is a Class 2 Radiology device with product code EAP cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K896963 · Tempo Technology, Inc. · Radiology device
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Jan 1990
Decision
38d
Days
Class 2
Risk

K896963 is an FDA 510(k) clearance for the TRIMODE SP DENTAL INTRA ORAL X-RAY. Classified as Unit, X-ray, Intraoral (product code EAP), Class II - Special Controls.

Submitted by Tempo Technology, Inc. (Columbia City, US). The FDA issued a Cleared decision on January 22, 1990 after a review of 38 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K896963

510(k) Number K896963 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1989
Decision Date January 22, 1990
Days to Decision 38 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 107d · This submission: 38d
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 41
Devices cleared under the same product code (EAP) and FDA review panel - the closest regulatory comparables to K896963.
HEALTHPAK X-RAY SOX BARRIERS
K923307 · Healthpak, Inc. · Jan 1993
PANORAMIC MODEL X-CALIBER X-RAY
K900681 · Belmont Equipment Corp. · May 1990
MDT/CASTLE MODEL HDX DENTAL X-RAY MACHINE
K896024 · Mdt Diagnostic Co. · Jan 1990
VARIABLE KV INTREX VSK 60 - 90 KVP
K883354 · Keystone X-Ray, Inc. · Dec 1988
MINIM-X 2001-CIAS & MINIM-X 2002-CIAS
K882379 · Dentomar, Inc. · Sep 1988
NEW BELMONT MODEL, MC-5 DENTAL, INTRAORAL X-RAY
K861328 · Belmont Equipment Corp. · Apr 1986
K896963 · TRIMODE SP DENTAL INTRA ORAL X-RAY
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