510(k) K033044
K033044 is an FDA 510(k) premarket notification submitted by American Green Dent. Mfg, Inc. for the device "DREAM CLEANSE S SCALER, DREAM COMPACT S SCALER". The FDA issued a decision of Substantially Equivalent on December 21, 2004. The device falls under product code ELC (Scaler, Ultrasonic), a Class II device regulated under 21 CFR 872.4850. American Green Dent. Mfg, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 21, 2004
- Date Received
- September 29, 2003
- 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