The following data is part of a premarket notification filed by Wieland Edelmetalle Gmbh & Co. with the FDA for Imagine H.e..
| Device ID | K012156 |
| 510k Number | K012156 |
| Device Name: | IMAGINE H.E. |
| Classification | Powder, Porcelain |
| Applicant | WIELAND EDELMETALLE GMBH & CO. SCHWENNINGER STRABE 13 Pforzheim, DE D-75179 |
| Contact | Gerhard Polzer |
| Correspondent | Gerhard Polzer WIELAND EDELMETALLE GMBH & CO. SCHWENNINGER STRABE 13 Pforzheim, DE D-75179 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-11 |
| Decision Date | 2001-08-16 |
| Summary: | summary |