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FDA 510(k)

DENTRON SENSOR

K-Number: K080738 · 2008-05-13

ApplicantDentron Systems, LLC
Decision Date2008-05-13
Product CodeEAP
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTRON SENSOR is the device name listed in this FDA 510(k) record. The listed applicant is Dentron Systems, LLC. It received FDA 510(k) clearance on 2008-05-13 under 510(k) number K080738. 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 DENTRON SENSOR?

DENTRON SENSOR is a medical device that received FDA 510(k) clearance on 2008-05-13. The listed applicant is Dentron Systems, LLC. The 510(k) number is K080738.

When did DENTRON SENSOR receive FDA 510(k) clearance?

DENTRON SENSOR received FDA 510(k) clearance on 2008-05-13, under 510(k) number K080738.

Who is the listed applicant for DENTRON SENSOR?

The FDA 510(k) record lists Dentron Systems, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DENTRON SENSOR?

The FDA product code for DENTRON SENSOR is EAP.

Related Clinical Trials

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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.K052422THE ENVISION INTRAORAL DENTAL X-RAY MACHINES (WALL MOUNTED AND MOBILE)Flow X-Ray Corp.K041385MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEMSchick Technologies, Inc.K960819HELIODENT DSPelton & Crane Co.

Official Source

View on FDA Database →

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

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