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FDA 510(k)

TRIMODE SP DENTAL INTRA ORAL X-RAY

K-Number: K896963 · 1990-01-22

ApplicantTempo Technology, Inc.
Decision Date1990-01-22
Product CodeEAP
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TRIMODE SP DENTAL INTRA ORAL X-RAY is the device name listed in this FDA 510(k) record. The listed applicant is Tempo Technology, Inc.. It received FDA 510(k) clearance on 1990-01-22 under 510(k) number K896963. The device is classified under product code EAP. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRIMODE SP DENTAL INTRA ORAL X-RAY?

TRIMODE SP DENTAL INTRA ORAL X-RAY is a medical device that received FDA 510(k) clearance on 1990-01-22. The listed applicant is Tempo Technology, Inc.. The 510(k) number is K896963.

When did TRIMODE SP DENTAL INTRA ORAL X-RAY receive FDA 510(k) clearance?

TRIMODE SP DENTAL INTRA ORAL X-RAY received FDA 510(k) clearance on 1990-01-22, under 510(k) number K896963.

Who is the listed applicant for TRIMODE SP DENTAL INTRA ORAL X-RAY?

The FDA 510(k) record lists Tempo Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRIMODE SP DENTAL INTRA ORAL X-RAY?

The FDA product code for TRIMODE SP DENTAL INTRA ORAL X-RAY is EAP.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Tempo Technology, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K963220TEMPRA COLD PACK, REORDER NO. TC150K934700MODEL 90P PORTABLE MEDICAL DIAGNOSTIC X-RAY

Related Devices (Code: EAP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K113360MEDICAL IMAGE PROCESSING UNITHumanray Co,LtdK102573PROVU (TM) DENTAL X-RAY SYSTEMAdvanced Image Science, Inc.K093453MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEMSchick Technologies, Inc.K080738DENTRON SENSORDentron Systems, LLCK052422THE ENVISION INTRAORAL DENTAL X-RAY MACHINES (WALL MOUNTED AND MOBILE)Flow X-Ray Corp.K041385MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEMSchick Technologies, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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