The following data is part of a premarket notification filed by Nobel Biocare Usa, Llc with the FDA for Nobelrondo Dental Ceramic - Zirconia.
| Device ID | K043312 |
| 510k Number | K043312 |
| Device Name: | NOBELRONDO DENTAL CERAMIC - ZIRCONIA |
| Classification | Powder, Porcelain |
| Applicant | NOBEL BIOCARE USA, LLC 22715 SAVI RANCH PARKWAY Yorba Linda, CA 92887 |
| Contact | Elizabeth J Mason |
| Correspondent | Elizabeth J Mason NOBEL BIOCARE USA, LLC 22715 SAVI RANCH PARKWAY Yorba Linda, CA 92887 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-01 |
| Decision Date | 2005-02-01 |
| Summary: | summary |