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FDA 510(k)

CORDLESS PORTABLE DENTAL X-RAY SYSTEM, MODEL ADX4000

K-Number: K070811 · 2007-07-05

ApplicantDexco
Decision Date2007-07-05
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CORDLESS PORTABLE DENTAL X-RAY SYSTEM, MODEL ADX4000 is the device name listed in this FDA 510(k) record. The listed applicant is Dexco. It received FDA 510(k) clearance on 2007-07-05 under 510(k) number K070811. 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 CORDLESS PORTABLE DENTAL X-RAY SYSTEM, MODEL ADX4000?

CORDLESS PORTABLE DENTAL X-RAY SYSTEM, MODEL ADX4000 is a medical device that received FDA 510(k) clearance on 2007-07-05. The listed applicant is Dexco. The 510(k) number is K070811.

When did CORDLESS PORTABLE DENTAL X-RAY SYSTEM, MODEL ADX4000 receive FDA 510(k) clearance?

CORDLESS PORTABLE DENTAL X-RAY SYSTEM, MODEL ADX4000 received FDA 510(k) clearance on 2007-07-05, under 510(k) number K070811.

Who is the listed applicant for CORDLESS PORTABLE DENTAL X-RAY SYSTEM, MODEL ADX4000?

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

What is the FDA product code for CORDLESS PORTABLE DENTAL X-RAY SYSTEM, MODEL ADX4000?

The FDA product code for CORDLESS PORTABLE DENTAL X-RAY SYSTEM, MODEL ADX4000 is MUH.

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Related Devices (Code: MUH)

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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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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