Sirotorque L
FDA 510(k) K031584 · Sirona Dental Systems GmbH
510(k) numberK031584
Submission
- Device name
- Sirotorque L
- Applicant
- Sirona Dental Systems GmbH
North Attleboro, MA, US - Received
- May 21, 2003
- Decision date
- August 19, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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Questions and answers
When was Sirotorque L cleared by the FDA?
Sirotorque L (K031584) received a 510(k) decision of Substantially Equivalent on August 19, 2003, 90 days after the submission was received.
What is the product code of K031584?
The FDA product code is EBW – Controller, Foot, Handpiece And Cord, a Class I (low risk) device regulated under 21 CFR 872.4200.