The following data is part of a premarket notification filed by Nobel Biocare Usa Llc with the FDA for Zygoma 17 Abutment Multi-unit Rp 2mm, Model 29314; Zygoma 17 Abutment Multi-unit Rp 3mm, Model 29315.
| Device ID | K052885 |
| 510k Number | K052885 |
| Device Name: | ZYGOMA 17 ABUTMENT MULTI-UNIT RP 2MM, MODEL 29314; ZYGOMA 17 ABUTMENT MULTI-UNIT RP 3MM, MODEL 29315 |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | NOBEL BIOCARE USA LLC 22715 SAVI RANCH PARKWAY Yorba Linda, CA 92887 |
| Contact | Herbert Crane |
| Correspondent | Herbert Crane NOBEL BIOCARE USA LLC 22715 SAVI RANCH PARKWAY Yorba Linda, CA 92887 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-13 |
| Decision Date | 2005-12-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332747112467 | K052885 | 000 |
| 07332747003840 | K052885 | 000 |
| 07332747003833 | K052885 | 000 |
| 07332747003154 | K052885 | 000 |
| 07332747003147 | K052885 | 000 |