The following data is part of a premarket notification filed by Coltène/whaledent Ag with the FDA for President The Original.
| Device ID | K220097 |
| 510k Number | K220097 |
| Device Name: | PRESIDENT The Original |
| Classification | Material, Impression |
| Applicant | Coltène/Whaledent AG Feldwiesenstrasse 20 Altstätten, CH 9450 |
| Contact | Katrin Ader |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2022-01-12 |
| Decision Date | 2022-01-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07640370883747 | K220097 | 000 |
| 07640370883907 | K220097 | 000 |
| 07640370884423 | K220097 | 000 |
| 07640370884386 | K220097 | 000 |
| 07640181479634 | K220097 | 000 |
| 07640181479641 | K220097 | 000 |
| 07640181479658 | K220097 | 000 |
| 07640181479665 | K220097 | 000 |
| 07640370884393 | K220097 | 000 |
| 07640181479689 | K220097 | 000 |
| 07640370884201 | K220097 | 000 |
| 07640181479702 | K220097 | 000 |
| 07640181479719 | K220097 | 000 |
| 07640181479580 | K220097 | 000 |