The following data is part of a premarket notification filed by Sds Dental, Inc. with the FDA for Delsonic 2000.
| Device ID | K990546 |
| 510k Number | K990546 |
| Device Name: | DELSONIC 2000 |
| Classification | Scaler, Ultrasonic |
| Applicant | SDS DENTAL, INC. 5101 N.W. 21ST AVE. N.W. SUITE 141 Fort Lauderdale, FL 33309 |
| Contact | Cesar Coral |
| Correspondent | Cesar Coral SDS DENTAL, INC. 5101 N.W. 21ST AVE. N.W. SUITE 141 Fort Lauderdale, FL 33309 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-22 |
| Decision Date | 1999-11-05 |
| Summary: | summary |