The following data is part of a premarket notification filed by Espe Dental Ag with the FDA for Pentamix 2.
| Device ID | K991913 |
| 510k Number | K991913 |
| Device Name: | PENTAMIX 2 |
| Classification | Amalgamator, Dental, Ac-powered |
| Applicant | ESPE DENTAL AG ESPE PLATZ Seefeld, Bavaria, DE D-82229 |
| Contact | A. Petermann |
| Correspondent | A. Petermann ESPE DENTAL AG ESPE PLATZ Seefeld, Bavaria, DE D-82229 |
| Product Code | EFD |
| CFR Regulation Number | 872.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-07 |
| Decision Date | 1999-07-26 |
| Summary: | summary |