The following data is part of a premarket notification filed by Espe Dental-medizin Gmbh & Co.kg. with the FDA for Compolute Aplicap.
| Device ID | K974458 |
| 510k Number | K974458 |
| Device Name: | COMPOLUTE APLICAP |
| Classification | Cement, Dental |
| Applicant | ESPE DENTAL-MEDIZIN GMBH & CO.KG. ESPE PLATZ Seefeld, DE D-82229 |
| Contact | Barbara Wagner-schuh |
| Correspondent | Barbara Wagner-schuh ESPE DENTAL-MEDIZIN GMBH & CO.KG. ESPE PLATZ Seefeld, DE D-82229 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-25 |
| Decision Date | 1998-02-02 |
| Summary: | summary |