Bonart Ultrasonic Scaler, Moedls ART-P3II Pro and Art-Mii Pro
FDA 510(k) K081550 · Bonart Co., Ltd.
510(k) numberK081550
Submission
- Device name
- Bonart Ultrasonic Scaler, Moedls ART-P3II Pro and Art-Mii Pro
- Applicant
- Bonart Co., Ltd.
Walnut, CA, US - Received
- June 3, 2008
- Decision date
- August 28, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Bonart Ultrasonic Scaler, Moedls ART-P3II Pro and Art-Mii Pro cleared by the FDA?
Bonart Ultrasonic Scaler, Moedls ART-P3II Pro and Art-Mii Pro (K081550) received a 510(k) decision of Substantially Equivalent on August 28, 2008, 86 days after the submission was received.
What is the product code of K081550?
The FDA product code is ELC – Scaler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 872.4850.