The following data is part of a premarket notification filed by Espe Gmbh (us) with the FDA for Espe Tulux-cem.
| Device ID | K891020 |
| 510k Number | K891020 |
| Device Name: | ESPE TULUX-CEM |
| Classification | Material, Tooth Shade, Resin |
| Applicant | ESPE GMBH (US) 200 LAKE AVENUE (#205) Lake Worth, FL 33460 |
| Contact | Harold A Opotow |
| Correspondent | Harold A Opotow ESPE GMBH (US) 200 LAKE AVENUE (#205) Lake Worth, FL 33460 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-28 |
| Decision Date | 1989-05-26 |