The following data is part of a premarket notification filed by Coltene, Inc. with the FDA for Coltene Oralloy Magicaps.
| Device ID | K840297 |
| 510k Number | K840297 |
| Device Name: | COLTENE ORALLOY MAGICAPS |
| Classification | Alloy, Amalgam |
| Applicant | COLTENE, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EJJ |
| CFR Regulation Number | 872.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-24 |
| Decision Date | 1984-03-16 |