The following data is part of a premarket notification filed by Nobel Biocare Ab with the FDA for Proceara Copings And Pontic.
| Device ID | K032562 |
| 510k Number | K032562 |
| Device Name: | PROCEARA COPINGS AND PONTIC |
| Classification | Teeth, Porcelain |
| Applicant | NOBEL BIOCARE AB 22725 SAVI RANCH PKWY. Yorba Linda, CA 92887 |
| Contact | Elizabeth J Mason |
| Correspondent | Elizabeth J Mason NOBEL BIOCARE AB 22725 SAVI RANCH PKWY. Yorba Linda, CA 92887 |
| Product Code | ELL |
| CFR Regulation Number | 872.3920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-20 |
| Decision Date | 2004-02-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332747100778 | K032562 | 000 |
| 07332747100761 | K032562 | 000 |
| 07332747100754 | K032562 | 000 |
| 07332747100747 | K032562 | 000 |
| 07332747100730 | K032562 | 000 |
| 07332747100723 | K032562 | 000 |
| 07332747100716 | K032562 | 000 |
| 07332747100709 | K032562 | 000 |