The following data is part of a premarket notification filed by Espe Dental Ag with the FDA for Lava Frame, Lava Frame Shade, Lava Ceram.
| Device ID | K011394 |
| 510k Number | K011394 |
| Device Name: | LAVA FRAME, LAVA FRAME SHADE, LAVA CERAM |
| Classification | Powder, Porcelain |
| 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 | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-07 |
| Decision Date | 2001-06-29 |