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FDA 510(k)

MYRAY HYPERION

K-Number: K101661 · 2010-09-16

ApplicantCefla Dental Group
Decision Date2010-09-16
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MYRAY HYPERION is the device name listed in this FDA 510(k) record. The listed applicant is Cefla Dental Group. It received FDA 510(k) clearance on 2010-09-16 under 510(k) number K101661. 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 MYRAY HYPERION?

MYRAY HYPERION is a medical device that received FDA 510(k) clearance on 2010-09-16. The listed applicant is Cefla Dental Group. The 510(k) number is K101661.

When did MYRAY HYPERION receive FDA 510(k) clearance?

MYRAY HYPERION received FDA 510(k) clearance on 2010-09-16, under 510(k) number K101661.

Who is the listed applicant for MYRAY HYPERION?

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

What is the FDA product code for MYRAY HYPERION?

The FDA product code for MYRAY HYPERION is MUH.

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Other records listing Cefla Dental Group 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.

K100960WDS X-POD AND ZEN-X DIGITAL X-RAY SENSORS

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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