The following data is part of a premarket notification filed by Ronvig A/s with the FDA for B&r Device.
| Device ID | K032925 |
| 510k Number | K032925 |
| Device Name: | B&R DEVICE |
| Classification | Handpiece, Contra- And Right-angle Attachment, Dental |
| Applicant | RONVIG A/S GL. VEJLEVEJ 57-59 Daugaard, DK 8721 |
| Contact | Annette Ravn Nielsen |
| Correspondent | Annette Ravn Nielsen RONVIG A/S GL. VEJLEVEJ 57-59 Daugaard, DK 8721 |
| Product Code | EGS |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-22 |
| Decision Date | 2003-12-22 |