FDA 510(k)

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

K-Number: K223173 · 2023-07-14

Decision Date2023-07-14

Product CodeELC

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Proxeo ULTRA (PB-510, PB-520 and PB-530) is a medical device manufactured by W&H Dentalwerk Buermoss GmbH. It received FDA 510(k) clearance on 2023-07-14 under approval number K223173. The device is classified under product code ELC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Proxeo ULTRA (PB-510, PB-520 and PB-530)?

Proxeo ULTRA (PB-510, PB-520 and PB-530) is a medical device that received FDA 510(k) clearance on 2023-07-14. It is manufactured by W&H Dentalwerk Buermoss GmbH. The 510(k) number is K223173.

When was Proxeo ULTRA (PB-510, PB-520 and PB-530) approved by the FDA?

Proxeo ULTRA (PB-510, PB-520 and PB-530) received FDA 510(k) clearance on 2023-07-14, under approval number K223173.

What company makes Proxeo ULTRA (PB-510, PB-520 and PB-530)?

Proxeo ULTRA (PB-510, PB-520 and PB-530) is manufactured by W&H Dentalwerk Buermoss GmbH.

What is the FDA product code for Proxeo ULTRA (PB-510, PB-520 and PB-530)?

The FDA product code for Proxeo ULTRA (PB-510, PB-520 and PB-530) is ELC.

Other Devices by W&H Dentalwerk Buermoss GmbH

K213221AMADEO, M-UK1015 (incl. attachments and accessories)

Related Devices (Code: ELC)

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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.