The following data is part of a premarket notification filed by Nobel Biocare Ab with the FDA for Procera Software, Model 33145.
| Device ID | K053602 |
| 510k Number | K053602 |
| Device Name: | PROCERA SOFTWARE, MODEL 33145 |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | NOBEL BIOCARE AB 22715 SAVI RANCH PARKWAY Yorba Linda, CA 92887 |
| Contact | Herbert Crane |
| Correspondent | Herbert Crane NOBEL BIOCARE AB 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 | 2005-12-23 |
| Decision Date | 2006-02-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332747124989 | K053602 | 000 |