The following data is part of a premarket notification filed by Dentmed Ltd. with the FDA for Brass Nick Impres Tray/amalgam Car/syrin Cart/arti.
| Device ID | K926121 |
| 510k Number | K926121 |
| Device Name: | BRASS NICK IMPRES TRAY/AMALGAM CAR/SYRIN CART/ARTI |
| Classification | Syringe, Cartridge |
| Applicant | DENTMED LTD. 4936-C EISENHOWER AVE. Alexandria, VA 22304 |
| Contact | Tabusum |
| Correspondent | Tabusum DENTMED LTD. 4936-C EISENHOWER AVE. Alexandria, VA 22304 |
| Product Code | EJI |
| CFR Regulation Number | 872.6770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-03 |
| Decision Date | 1994-02-03 |