510(k) K050354
K050354 is an FDA 510(k) premarket notification submitted by Sirona Dental Systems GmbH for the device "PERIOSCAN ULTRASONIC SCALER". The FDA issued a decision of Substantially Equivalent on Mar 21, 2005. The device falls under product code ELC (Scaler, Ultrasonic), a Class II device regulated under 21 CFR 872.4850. Sirona Dental Systems GmbH has 41 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 21, 2005
- Date Received
- Feb 14, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Scaler, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 872.4850
- Review Panel
- DE
- Submission Type
- 510(k)