Proxeo ULTRA (PB-510, PB-520 and PB-530)
FDA 510(k) K223173 · W&H Dentalwerk Buermoss GmbH
510(k) numberK223173
Submission
- Device name
- Proxeo ULTRA (PB-510, PB-520 and PB-530)
- Applicant
- W&H Dentalwerk Buermoss GmbH
Buermoos, AT - Received
- October 11, 2022
- Decision date
- July 14, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Proxeo ULTRA (PB-510, PB-520 and PB-530) cleared by the FDA?
Proxeo ULTRA (PB-510, PB-520 and PB-530) (K223173) received a 510(k) decision of Substantially Equivalent on July 14, 2023, 276 days after the submission was received.
What is the product code of K223173?
The FDA product code is ELC – Scaler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 872.4850.