Trimode SP Dental Intra Oral X-Ray

FDA 510(k) K896963 · Tempo Technology, Inc.

Substantially Equivalent

510(k) numberK896963

Submission

Device name
Trimode SP Dental Intra Oral X-Ray
Applicant
Tempo Technology, Inc.
Columbia City, IN, US
Received
December 15, 1989
Decision date
January 22, 1990
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
EAP – Unit, X-Ray, Intraoral
Device class
Class II (moderate risk)
Regulation
21 CFR 872.1810
Specialty
Dental

Other 510(k)s with product code EAP

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K113360Medical Image Processing UnitEAP · Special Humanray Co,Ltd02/07/2012SE
K102573Provu (TM) Dental X-Ray SystemEAP · Traditional Advanced Image Science, Inc.06/30/2011SE
K093453Modification to Computed Oral Radiology SystemEAP · Special Schick Technologies, Inc.11/30/2009SE
K080738Dentron SensorEAP · Traditional Dentron Systems, LLC05/13/2008SE
K052422The Envision Intraoral Dental X-Ray Machines (Wall Mounted and Mobile)EAP · Special Flow X-Ray Corp.09/27/2005SE
K041385Modification to Computed Oral Radiology SystemEAP · Special Schick Technologies, Inc.06/07/2004SE
K960819Heliodent DSEAP · Traditional Pelton & Crane Co.03/29/1996SE
K960028Orthoralix SD2 & S Panoramic Dental X-Ray SystemEAP · Traditional Dentsply Intl.03/01/1996SE
K953936AtlantisEAP · Traditional Trophy Radiologie12/28/1995SE
K954565Explor-X (Azteh) HFEAP · Traditional Chicago X-Ray Systems, Inc.10/27/1995SE

More from Chicago X-Ray Systems, Inc.

510(k)DeviceDecision
K963220Tempra Cold Pack, Reorder No. TC150IMD · Traditional 10/10/1996SE
K934700Model 90P Portable Medical Diagnostic X-RayOXO · Traditional 03/16/1994SE

Questions and answers

When was Trimode SP Dental Intra Oral X-Ray cleared by the FDA?

Trimode SP Dental Intra Oral X-Ray (K896963) received a 510(k) decision of Substantially Equivalent on January 22, 1990, 38 days after the submission was received.

What is the product code of K896963?

The FDA product code is EAP – Unit, X-Ray, Intraoral, a Class II (moderate risk) device regulated under 21 CFR 872.1810.