The following data is part of a premarket notification filed by Artiberia with the FDA for 865/1 To 875/3 Various Types Of Dental Bone Files.
| Device ID | K851716 |
| 510k Number | K851716 |
| Device Name: | 865/1 TO 875/3 VARIOUS TYPES OF DENTAL BONE FILES |
| Classification | File, Bone, Surgical |
| Applicant | ARTIBERIA 4518 LOS RANCHITOS San Antonio, TX 78233 |
| Contact | Gil M Sanchez |
| Correspondent | Gil M Sanchez ARTIBERIA 4518 LOS RANCHITOS San Antonio, TX 78233 |
| Product Code | EMI |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-25 |
| Decision Date | 1985-06-11 |