The following data is part of a premarket notification filed by Espe Dental Products with the FDA for Capmix.
| Device ID | K771901 |
| 510k Number | K771901 |
| Device Name: | CAPMIX |
| Classification | Amalgamator, Dental, Ac-powered |
| Applicant | ESPE DENTAL PRODUCTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EFD |
| CFR Regulation Number | 872.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-10-07 |
| Decision Date | 1977-10-20 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() CAPMIX 73781954 1562042 Dead/Cancelled |
ESPE FABRIK PHARMAZEUTISCHER PRAPARATE GMBH & CO. KG 1989-02-21 |
![]() CAPMIX 73218188 1163576 Dead/Cancelled |
Espe Fabrik Pharmazeutischer Praparate GmbH 1979-06-04 |