The following data is part of a premarket notification filed by Centrix, Inc. with the FDA for Access Impression Barrel.
| Device ID | K913974 |
| 510k Number | K913974 |
| Device Name: | ACCESS IMPRESSION BARREL |
| Classification | Syringe, Restorative And Impression Material |
| Applicant | CENTRIX, INC. 30 STRAN RD. Milford, CT 06460 |
| Contact | John Discko |
| Correspondent | John Discko CENTRIX, INC. 30 STRAN RD. Milford, CT 06460 |
| Product Code | EID |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-06 |
| Decision Date | 1992-02-25 |