The following data is part of a premarket notification filed by Dentsply International with the FDA for Ceram X Universal Mano-ceramic Restorative.
| Device ID | K052097 |
| 510k Number | K052097 |
| Device Name: | CERAM X UNIVERSAL MANO-CERAMIC RESTORATIVE |
| Classification | Material, Tooth Shade, Resin |
| Applicant | DENTSPLY INTERNATIONAL 221 W. PHILADELPHIA ST.,STE 60 SUSQUEHANNA COMMERCE CTR. WEST York, PA 17404 |
| Contact | Helen Lewis |
| Correspondent | Helen Lewis DENTSPLY INTERNATIONAL 221 W. PHILADELPHIA ST.,STE 60 SUSQUEHANNA COMMERCE CTR. WEST York, PA 17404 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-03 |
| Decision Date | 2005-08-12 |
| Summary: | summary |