510(k) K070866
K070866 is an FDA 510(k) premarket notification submitted by Aseptico, Inc. for the device "ASC-12 PIEZOELECTRIC SCALER". The FDA issued a decision of Substantially Equivalent on April 11, 2007. The device falls under product code ELC (Scaler, Ultrasonic), a Class II device regulated under 21 CFR 872.4850. Aseptico, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 11, 2007
- Date Received
- March 29, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Scaler, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 872.4850
- Review Panel
- DE
- Submission Type