The following data is part of a premarket notification filed by Sirona Dental Systems Gmbh with the FDA for Siroair L Air Scaler.
| Device ID | K033812 |
| 510k Number | K033812 |
| Device Name: | SIROAIR L AIR SCALER |
| Classification | Handpiece, Air-powered, Dental |
| 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 | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-09 |
| Decision Date | 2004-02-23 |
| Summary: | summary |