Mastertorque Lux 8900 L
FDA 510(k) K130560 · Kaltenbach & Voigt GmbH
510(k) numberK130560
Submission
- Device name
- Mastertorque Lux 8900 L
- Applicant
- Kaltenbach & Voigt GmbH
Biberach, DE - Received
- March 4, 2013
- Decision date
- September 27, 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 Mastertorque Lux 8900 L cleared by the FDA?
Mastertorque Lux 8900 L (K130560) received a 510(k) decision of Substantially Equivalent on September 27, 2013, 207 days after the submission was received.
What is the product code of K130560?
The FDA product code is EFB – Handpiece, Air-Powered, Dental, a Class I (low risk) device regulated under 21 CFR 872.4200.