510(k) K083059
K083059 is an FDA 510(k) premarket notification submitted by Dpm USA Corp. for the device "AIR SONIC SCALER". The FDA issued a decision of Substantially Equivalent on January 30, 2009. The device falls under product code ELC (Scaler, Ultrasonic), a Class II device regulated under 21 CFR 872.4850. Dpm USA Corp. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 30, 2009
- Date Received
- October 14, 2008
- 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