The following data is part of a premarket notification filed by Henry Schein, Inc. with the FDA for Vanadium Excavators Sizes 0-6.
| Device ID | K834055 |
| 510k Number | K834055 |
| Device Name: | VANADIUM EXCAVATORS SIZES 0-6 |
| Classification | Excavator, Dental, Operative |
| Applicant | HENRY SCHEIN, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EKC |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-11-23 |
| Decision Date | 1984-02-21 |