The following data is part of a premarket notification filed by Nobel Biocare Uas Inc with the FDA for Auradapt Aubtment System.
| Device ID | K972475 |
| 510k Number | K972475 |
| Device Name: | AURADAPT AUBTMENT SYSTEM |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | NOBEL BIOCARE UAS INC 777 OAKMONT LANE, SUITE 100 Westmont, IL 60559 |
| Contact | Betsy A Brown |
| Correspondent | Betsy A Brown NOBEL BIOCARE UAS INC 777 OAKMONT LANE, SUITE 100 Westmont, IL 60559 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-01 |
| Decision Date | 1997-09-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332747010527 | K972475 | 000 |
| 07332747034653 | K972475 | 000 |
| 07332747010428 | K972475 | 000 |
| 07332747010497 | K972475 | 000 |
| 07332747010367 | K972475 | 000 |
| 07332747010374 | K972475 | 000 |
| 07332747010398 | K972475 | 000 |
| 07332747010404 | K972475 | 000 |
| 07332747010411 | K972475 | 000 |
| 07332747010442 | K972475 | 000 |
| 07332747010459 | K972475 | 000 |
| 07332747010466 | K972475 | 000 |
| 07332747010473 | K972475 | 000 |
| 07332747010480 | K972475 | 000 |
| 07332747010510 | K972475 | 000 |
| 07332747034646 | K972475 | 000 |