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FDA 510(k)

AMADEO, M-UK1015 (incl. attachments and accessories)

K-Number: K213221 · 2022-05-26

ApplicantW&H Dentalwerk Buermoss GmbH
Decision Date2022-05-26
Product CodeERL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

AMADEO, M-UK1015 (incl. attachments and accessories) is a medical device manufactured by W&H Dentalwerk Buermoss GmbH. It received FDA 510(k) clearance on 2022-05-26 under approval number K213221. The device is classified under product code ERL. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMADEO, M-UK1015 (incl. attachments and accessories)?

AMADEO, M-UK1015 (incl. attachments and accessories) is a medical device that received FDA 510(k) clearance on 2022-05-26. It is manufactured by W&H Dentalwerk Buermoss GmbH. The 510(k) number is K213221.

When was AMADEO, M-UK1015 (incl. attachments and accessories) approved by the FDA?

AMADEO, M-UK1015 (incl. attachments and accessories) received FDA 510(k) clearance on 2022-05-26, under approval number K213221.

What company makes AMADEO, M-UK1015 (incl. attachments and accessories)?

AMADEO, M-UK1015 (incl. attachments and accessories) is manufactured by W&H Dentalwerk Buermoss GmbH.

What is the FDA product code for AMADEO, M-UK1015 (incl. attachments and accessories)?

The FDA product code for AMADEO, M-UK1015 (incl. attachments and accessories) is ERL.

Other Devices by W&H Dentalwerk Buermoss GmbH

K223173Proxeo ULTRA (PB-510, PB-520 and PB-530)

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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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