The following data is part of a premarket notification filed by Dpm Usa Corp. with the FDA for Air Sonic Scaler.
| Device ID | K083059 |
| 510k Number | K083059 |
| Device Name: | AIR SONIC SCALER |
| Classification | Scaler, Ultrasonic |
| Applicant | DPM USA CORP. 1460 NW 107 AVE. SUITE G Miami, FL 33172 |
| Contact | George Echeverri |
| Correspondent | George Echeverri DPM USA CORP. 1460 NW 107 AVE. SUITE G Miami, FL 33172 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-14 |
| Decision Date | 2009-01-30 |
| Summary: | summary |