Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessori
Summary
W&H Dentalwerk Buermoos GmbH received 510(k) clearance for Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories), a ERL device. Cleared on 2025-07-03.
Details
Source
510(k) Clearance
External ID
K243280
Action Date
2025-07-03
Status
Traditional
Category
device
Product Code
ERL
Product Description
Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories). Product code: ERL.
Company
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month. W&H Dentalwerk Buermoos GmbH has received 2 total clearances in our database.
W&H Dentalwerk Buermoos GmbH has 3 FDA actions in our database, including 1 recall and 2 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does W&H Dentalwerk Buermoos GmbH have FDA actions?
W&H Dentalwerk Buermoos GmbH has 3 FDA actions in our database, including 1 recall and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K243280" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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