The following data is part of a premarket notification filed by Coltene, Inc. with the FDA for Coltene President Jet Impression Materials System.
| Device ID | K873671 |
| 510k Number | K873671 |
| Device Name: | COLTENE PRESIDENT JET IMPRESSION MATERIALS SYSTEM |
| Classification | File, Pulp Canal, Endodontic |
| Applicant | COLTENE, INC. C/O ROBERT BAUER & ASSOCIATES 111 N. WABASH Chicago, IL 60602 |
| Contact | Robert W Bauer |
| Correspondent | Robert W Bauer COLTENE, INC. C/O ROBERT BAUER & ASSOCIATES 111 N. WABASH Chicago, IL 60602 |
| Product Code | EKS |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-11 |
| Decision Date | 1987-10-27 |