The following data is part of a premarket notification filed by White Peaks Dental Systems Gmbh & Co. Kg with the FDA for Copra Temp Pmma-disk.
| Device ID | K131664 |
| 510k Number | K131664 |
| Device Name: | COPRA TEMP PMMA-DISK |
| Classification | Crown And Bridge, Temporary, Resin |
| Applicant | WHITE PEAKS DENTAL SYSTEMS GMBH & CO. KG 361 FARMINGTON AVENUE Louisville, KY 40217 |
| Contact | John Waters |
| Correspondent | John Waters WHITE PEAKS DENTAL SYSTEMS GMBH & CO. KG 361 FARMINGTON AVENUE Louisville, KY 40217 |
| Product Code | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-07 |
| Decision Date | 2013-12-18 |
| Summary: | summary |