510(k) K051661
K051661 is an FDA 510(k) premarket notification submitted by Sirona Dental Systems GmbH for the device "IMPLANT HANDPIECES". The FDA issued a decision of Substantially Equivalent on Sep 6, 2005. The device falls under product code EKX (Handpiece, Direct Drive, Ac-Powered), 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
- Sep 6, 2005
- Date Received
- Jun 22, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Handpiece, Direct Drive, Ac-Powered
- Device Class
- Class I
- Regulation Number
- 872.4200
- Review Panel
- DE
- Submission Type
- 510(k)