510(k) K123139
K123139 is an FDA 510(k) premarket notification submitted by Asi Medical, Inc. for the device "ADVANCED ENDODONTIC SYSTEM- DESIGNER SERIES". The FDA issued a decision of Substantially Equivalent on March 28, 2013. The device falls under product code ELC (Scaler, Ultrasonic), a Class II device regulated under 21 CFR 872.4850. Asi Medical, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 28, 2013
- Date Received
- October 5, 2012
- 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