The following data is part of a premarket notification filed by Sirona Dental Systems Gmbh with the FDA for Siroendo.
| Device ID | K052515 |
| 510k Number | K052515 |
| Device Name: | SIROENDO |
| Classification | Handpiece, Direct Drive, Ac-powered |
| 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 | EKX |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-14 |
| Decision Date | 2006-03-31 |
| Summary: | summary |