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FDA 510(k)

FIRECR DENTALIMAGING SYSTEM

K-Number: K131442 · 2013-09-06

Applicant3Disc Americas
Decision Date2013-09-06
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FIRECR DENTALIMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is 3Disc Americas. It received FDA 510(k) clearance on 2013-09-06 under 510(k) number K131442. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIRECR DENTALIMAGING SYSTEM?

FIRECR DENTALIMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 2013-09-06. The listed applicant is 3Disc Americas. The 510(k) number is K131442.

When did FIRECR DENTALIMAGING SYSTEM receive FDA 510(k) clearance?

FIRECR DENTALIMAGING SYSTEM received FDA 510(k) clearance on 2013-09-06, under 510(k) number K131442.

Who is the listed applicant for FIRECR DENTALIMAGING SYSTEM?

The FDA 510(k) record lists 3Disc Americas as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FIRECR DENTALIMAGING SYSTEM?

The FDA product code for FIRECR DENTALIMAGING SYSTEM is MUH.

Related Clinical Trials

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Other records listing 3Disc Americas 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.

K102619COMPUTED RADDIOGRAPHY SCANNER

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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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