The following data is part of a premarket notification filed by Schutz-dental Gmbh with the FDA for Futurapress Lt, N And Hp, Futurajet, Futuraself, Futuragen And Futuracryl 2000.
| Device ID | K052073 |
| 510k Number | K052073 |
| Device Name: | FUTURAPRESS LT, N AND HP, FUTURAJET, FUTURASELF, FUTURAGEN AND FUTURACRYL 2000 |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | SCHUTZ-DENTAL GMBH DIESELSTRASSE 5-6 Rosbach, Hessen, DE D-61191 |
| Contact | Michael Wierz |
| Correspondent | Michael Wierz SCHUTZ-DENTAL GMBH DIESELSTRASSE 5-6 Rosbach, Hessen, DE D-61191 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-01 |
| Decision Date | 2005-10-26 |