The following data is part of a premarket notification filed by Wieland Dental + Technik Gmbh & Co. Kg with the FDA for Auropal 60.
| Device ID | K021926 |
| 510k Number | K021926 |
| Device Name: | AUROPAL 60 |
| Classification | Alloy, Gold-based Noble Metal |
| Applicant | WIELAND DENTAL + TECHNIK GMBH & CO. KG SCHWENNINGER STRABE 13 Pforzheim, DE D-75179 |
| Contact | Gerhard Polzer |
| Correspondent | Gerhard Polzer WIELAND DENTAL + TECHNIK GMBH & CO. KG SCHWENNINGER STRABE 13 Pforzheim, DE D-75179 |
| Product Code | EJT |
| CFR Regulation Number | 872.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-12 |
| Decision Date | 2002-07-25 |
| Summary: | summary |