The following data is part of a premarket notification filed by Nobel Biocare Uas Inc with the FDA for Procera Allceram Fusing Material.
| Device ID | K983453 |
| 510k Number | K983453 |
| Device Name: | PROCERA ALLCERAM FUSING MATERIAL |
| Classification | Powder, Porcelain |
| Applicant | NOBEL BIOCARE UAS INC 777 OAKMONT LANE, SUITE 100 Westmont, IL 60559 |
| Contact | Betsy A Brown |
| Correspondent | Betsy A Brown NOBEL BIOCARE UAS INC 777 OAKMONT LANE, SUITE 100 Westmont, IL 60559 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-30 |
| Decision Date | 1998-11-18 |
| Summary: | summary |