The following data is part of a premarket notification filed by Coltene, Inc. with the FDA for Coltene President Impression Materials.
| Device ID | K811767 |
| 510k Number | K811767 |
| Device Name: | COLTENE PRESIDENT IMPRESSION MATERIALS |
| Classification | Material, Impression |
| Applicant | COLTENE, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-06-22 |
| Decision Date | 1981-07-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| J00655060 | K811767 | 000 |
| J00655120 | K811767 | 000 |
| J00655010 | K811767 | 000 |
| J00649230 | K811767 | 000 |
| J00649200 | K811767 | 000 |
| J00647620 | K811767 | 000 |
| J00647610 | K811767 | 000 |
| J00647600 | K811767 | 000 |
| J00647590 | K811767 | 000 |
| J00647580 | K811767 | 000 |
| J00655130 | K811767 | 000 |
| J006600109260 | K811767 | 000 |
| J006600112000 | K811767 | 000 |
| J00655150 | K811767 | 000 |
| J00655140 | K811767 | 000 |
| J0065510LA0 | K811767 | 000 |
| J00649220 | K811767 | 000 |
| J00649210 | K811767 | 000 |
| J006600113650 | K811767 | 000 |
| J006600113620 | K811767 | 000 |
| J006600113560 | K811767 | 000 |
| J006600113490 | K811767 | 000 |
| J00647570 | K811767 | 000 |