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FDA 510(k)

MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM

K-Number: K041385 · 2004-06-07

ApplicantSchick Technologies, Inc.
Decision Date2004-06-07
Product CodeEAP
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Schick Technologies, Inc.. It received FDA 510(k) clearance on 2004-06-07 under 510(k) number K041385. 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 MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM?

MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM is a medical device that received FDA 510(k) clearance on 2004-06-07. The listed applicant is Schick Technologies, Inc.. The 510(k) number is K041385.

When did MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM received FDA 510(k) clearance on 2004-06-07, under 510(k) number K041385.

Who is the listed applicant for MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM?

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

What is the FDA product code for MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM?

The FDA product code for MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM 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.

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Other records listing Schick Technologies, 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.

K110768COMPUTED DENTAL RADIOGRAPHYK093453MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEMK072134SCHICK COMPUTED ORAL RADIOLOGY SYSTEMK053558CEPH, MODEL 4900K031291CDR PANX, MODEL 4792K022953MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM

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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.K080738DENTRON SENSORDentron Systems, LLCK052422THE ENVISION INTRAORAL DENTAL X-RAY MACHINES (WALL MOUNTED AND MOBILE)Flow X-Ray Corp.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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