The following data is part of a premarket notification filed by White Peaks Dental Systems Gmbh & Co. Kg with the FDA for Copran Zr/origin Yz.
| Device ID | K092496 |
| 510k Number | K092496 |
| Device Name: | COPRAN ZR/ORIGIN YZ |
| Classification | Powder, Porcelain |
| Applicant | WHITE PEAKS DENTAL SYSTEMS GMBH & CO. KG LANGHEIDE 9 Essen, DE 45239 |
| Contact | Oliver Puckert |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-08-14 |
| Decision Date | 2009-09-18 |
| Summary: | summary |