510(k) K031584
K031584 is an FDA 510(k) premarket notification submitted by Sirona Dental Systems GmbH for the device "SIROTORQUE L". The FDA issued a decision of Substantially Equivalent on Aug 19, 2003. The device falls under product code EBW (Controller, Foot, Handpiece And Cord), a Class I device regulated under 21 CFR 872.4200. Sirona Dental Systems GmbH has 41 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 19, 2003
- Date Received
- May 21, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device classification
- Device Name
- Controller, Foot, Handpiece And Cord
- Device Class
- Class I
- Regulation Number
- 872.4200
- Review Panel
- DE
- Submission Type
- 510(k)