The following data is part of a premarket notification filed by Vivadent (usa), Inc. with the FDA for Vivadent Filpin.
| Device ID | K863831 |
| 510k Number | K863831 |
| Device Name: | VIVADENT FILPIN |
| Classification | Pin, Retentive And Splinting, And Accessory Instruments |
| Applicant | VIVADENT (USA), INC. 182 WALES ST. P.O. BOX 304 Tonawanda, NY 14150 |
| Contact | George W Tysowsky |
| Correspondent | George W Tysowsky VIVADENT (USA), INC. 182 WALES ST. P.O. BOX 304 Tonawanda, NY 14150 |
| Product Code | EBL |
| CFR Regulation Number | 872.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-30 |
| Decision Date | 1986-10-14 |