Biosonic Suvi Piezeoelectric Scaler and Polisher
FDA 510(k) K130137 · Coltene/Whaledent
510(k) numberK130137
Submission
- Device name
- Biosonic Suvi Piezeoelectric Scaler and Polisher
- Applicant
- Coltene/Whaledent
Cleveland, OH, US - Received
- January 18, 2013
- Decision date
- August 23, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Biosonic Suvi Piezeoelectric Scaler and Polisher cleared by the FDA?
Biosonic Suvi Piezeoelectric Scaler and Polisher (K130137) received a 510(k) decision of Substantially Equivalent on August 23, 2013, 217 days after the submission was received.
What is the product code of K130137?
The FDA product code is ELC – Scaler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 872.4850.