The following data is part of a premarket notification filed by Nobel Biocare Ab with the FDA for Procera Bridge Zirconia 9 Units-14 Units, Models 30-4004 To 30-4013.
| Device ID | K071182 |
| 510k Number | K071182 |
| Device Name: | PROCERA BRIDGE ZIRCONIA 9 UNITS-14 UNITS, MODELS 30-4004 TO 30-4013 |
| Classification | Teeth, Porcelain |
| Applicant | NOBEL BIOCARE AB 22715 SAVI RANCH PARKWAY Yorba Linda, CA 92887 |
| Contact | Phuong Nguyen Son |
| Correspondent | Phuong Nguyen Son NOBEL BIOCARE AB 22715 SAVI RANCH PARKWAY 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 | 2007-04-30 |
| Decision Date | 2007-07-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332747119343 | K071182 | 000 |
| 07332747119213 | K071182 | 000 |
| 07332747119206 | K071182 | 000 |
| 07332747119190 | K071182 | 000 |
| 07332747119183 | K071182 | 000 |
| 07332747119176 | K071182 | 000 |
| 07332747119169 | K071182 | 000 |
| 07332747119152 | K071182 | 000 |
| 07332747119145 | K071182 | 000 |
| 07332747119138 | K071182 | 000 |
| 07332747119121 | K071182 | 000 |
| 07332747119220 | K071182 | 000 |
| 07332747119237 | K071182 | 000 |
| 07332747119336 | K071182 | 000 |
| 07332747119329 | K071182 | 000 |
| 07332747119312 | K071182 | 000 |
| 07332747119305 | K071182 | 000 |
| 07332747119299 | K071182 | 000 |
| 07332747119282 | K071182 | 000 |
| 07332747119275 | K071182 | 000 |
| 07332747119268 | K071182 | 000 |
| 07332747119251 | K071182 | 000 |
| 07332747119244 | K071182 | 000 |
| 07332747119114 | K071182 | 000 |