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FDA 510(k)

Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories)

K-Number: K243280 · 2025-07-03

ApplicantW&H Dentalwerk Buermoos GmbH
Decision Date2025-07-03
Product CodeERL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories) is a medical device manufactured by W&H Dentalwerk Buermoos GmbH. It received FDA 510(k) clearance on 2025-07-03 under approval number K243280. 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 Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories)?

Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories) is a medical device that received FDA 510(k) clearance on 2025-07-03. It is manufactured by W&H Dentalwerk Buermoos GmbH. The 510(k) number is K243280.

When was Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories) approved by the FDA?

Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories) received FDA 510(k) clearance on 2025-07-03, under approval number K243280.

What company makes Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories)?

Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories) is manufactured by W&H Dentalwerk Buermoos GmbH.

What is the FDA product code for Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories)?

The FDA product code for Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories) is ERL.

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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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