The following data is part of a premarket notification filed by Davis Schottlander & Davis, Ltd. with the FDA for Schottlander Enigma Colour Tone, Model 0156.
| Device ID | K001463 |
| 510k Number | K001463 |
| Device Name: | SCHOTTLANDER ENIGMA COLOUR TONE, MODEL 0156 |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | DAVIS SCHOTTLANDER & DAVIS, LTD. 124 E. MISSOURI AVE. Kansas City, MO 64106 |
| Contact | Clark Smith |
| Correspondent | Clark Smith DAVIS SCHOTTLANDER & DAVIS, LTD. 124 E. MISSOURI AVE. Kansas City, MO 64106 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-10 |
| Decision Date | 2000-06-16 |