Bonart ART-L5 LED Cordless Curing Light
FDA 510(k) K082971 · Bonart Co., Ltd.
510(k) numberK082971
Submission
- Device name
- Bonart ART-L5 LED Cordless Curing Light
- Applicant
- Bonart Co., Ltd.
Walnut, CA, US - Received
- October 6, 2008
- Decision date
- November 13, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K071981 | Bonart Model ART-P6 Piezo Electric Ultrasonic Scaler & Accessories (Tips)ELC · Traditional | 10/26/2007SE |
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Questions and answers
When was Bonart ART-L5 LED Cordless Curing Light cleared by the FDA?
Bonart ART-L5 LED Cordless Curing Light (K082971) received a 510(k) decision of Substantially Equivalent on November 13, 2008, 38 days after the submission was received.
What is the product code of K082971?
The FDA product code is EBZ – Activator, Ultraviolet, For Polymerization, a Class II (moderate risk) device regulated under 21 CFR 872.6070.