The following data is part of a premarket notification filed by Sirona Dental Systems Gmbh with the FDA for Siroson L And Sirosonic L Ultrasonic Scalers.
| Device ID | K033640 |
| 510k Number | K033640 |
| Device Name: | SIROSON L AND SIROSONIC L ULTRASONIC SCALERS |
| Classification | Scaler, Ultrasonic |
| Applicant | SIRONA DENTAL SYSTEMS GMBH 49 PLAIN ST. North Attleboro, MA 02760 -4153 |
| Contact | Mary Mcnamara-cullinane |
| Correspondent | Mary Mcnamara-cullinane SIRONA DENTAL SYSTEMS GMBH 49 PLAIN ST. North Attleboro, MA 02760 -4153 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-20 |
| Decision Date | 2003-12-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E27665628342 | K033640 | 000 |
| E27663430780 | K033640 | 000 |
| E27660448330 | K033640 | 000 |
| E27659135090 | K033640 | 000 |