The following data is part of a premarket notification filed by Sirona Dental Systems Gmbh with the FDA for Sirotorque L.
| Device ID | K031584 |
| 510k Number | K031584 |
| Device Name: | SIROTORQUE L |
| Classification | Controller, Foot, Handpiece And Cord |
| Applicant | SIRONA DENTAL SYSTEMS GMBH 49 PLAIN ST. North Attleboro, MA 02760 -4153 |
| Contact | Mary Mcnamara-cullinane |
| Correspondent | Derwyn Reuber INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | EBW |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-05-21 |
| Decision Date | 2003-08-19 |
| Summary: | summary |