The following data is part of a premarket notification filed by Factor, Ii, Inc. with the FDA for Royale Ii.
| Device ID | K831095 |
| 510k Number | K831095 |
| Device Name: | ROYALE II |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | FACTOR, II, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-04-04 |
| Decision Date | 1983-08-31 |