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FDA 510(k)

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

K-Number: K223173 · 2023-07-14

ApplicantW&H Dentalwerk Buermoss GmbH
Decision Date2023-07-14
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Proxeo ULTRA (PB-510, PB-520 and PB-530) is the device name listed in this FDA 510(k) record. The listed applicant is W&H Dentalwerk Buermoss GmbH. It received FDA 510(k) clearance on 2023-07-14 under 510(k) 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. The listed applicant is W&H Dentalwerk Buermoss GmbH. The 510(k) number is K223173.

When did Proxeo ULTRA (PB-510, PB-520 and PB-530) receive FDA 510(k) clearance?

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

Who is the listed applicant for Proxeo ULTRA (PB-510, PB-520 and PB-530)?

The FDA 510(k) record lists W&H Dentalwerk Buermoss GmbH as the applicant. This does not by itself establish the device manufacturer.

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 records listing W&H Dentalwerk Buermoss GmbH 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.

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.

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