The following data is part of a premarket notification filed by Espe Dental Ag with the FDA for Dimension Penta H, Dimension Penta H Quick.
| Device ID | K000591 |
| 510k Number | K000591 |
| Device Name: | DIMENSION PENTA H, DIMENSION PENTA H QUICK |
| Classification | Material, Impression |
| Applicant | ESPE DENTAL AG ESPE PLATZ Seefeld, Bavaria, DE D-82229 |
| Contact | Andreas Petermann |
| Correspondent | Andreas Petermann ESPE DENTAL AG ESPE PLATZ Seefeld, Bavaria, DE D-82229 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-22 |
| Decision Date | 2000-03-30 |