Electrotorque TLC
FDA 510(k) K103027 · Kaltenbach & Voigt GmbH
510(k) numberK103027
Submission
- Device name
- Electrotorque TLC
- Applicant
- Kaltenbach & Voigt GmbH
Orange, CA, US - Received
- October 13, 2010
- Decision date
- August 19, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Electrotorque TLC cleared by the FDA?
Electrotorque TLC (K103027) received a 510(k) decision of Substantially Equivalent on August 19, 2011, 310 days after the submission was received.
What is the product code of K103027?
The FDA product code is EBW – Controller, Foot, Handpiece And Cord, a Class I (low risk) device regulated under 21 CFR 872.4200.