The following data is part of a premarket notification filed by American Green Dent. Mfg, Inc. with the FDA for Dream Cleanse S Scaler, Dream Compact S Scaler.
| Device ID | K033044 |
| 510k Number | K033044 |
| Device Name: | DREAM CLEANSE S SCALER, DREAM COMPACT S SCALER |
| Classification | Scaler, Ultrasonic |
| Applicant | AMERICAN GREEN DENT. MFG, INC. 3432 E. 14TH STREET Los Angeles, CA 90023 |
| Contact | Andrew Rowe |
| Correspondent | Andrew Rowe AMERICAN GREEN DENT. MFG, INC. 3432 E. 14TH STREET Los Angeles, CA 90023 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-29 |
| Decision Date | 2004-12-21 |