ESTETICA Dental Treatment Unit and Accessories
FDA 510(k) K161488 · Kaltenbach & Voigt GmbH
510(k) numberK161488
Submission
- Device name
- ESTETICA Dental Treatment Unit and Accessories
- Applicant
- Kaltenbach & Voigt GmbH
Biberach, DE - Received
- June 1, 2016
- Decision date
- December 8, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was ESTETICA Dental Treatment Unit and Accessories cleared by the FDA?
ESTETICA Dental Treatment Unit and Accessories (K161488) received a 510(k) decision of Substantially Equivalent on December 8, 2016, 190 days after the submission was received.
What is the product code of K161488?
The FDA product code is EIA – Unit, Operative Dental, a Class I (low risk) device regulated under 21 CFR 872.6640.