The following data is part of a premarket notification filed by Argen Corporation with the FDA for Argenis Titanium Abutments.
| Device ID | K160248 |
| 510k Number | K160248 |
| Device Name: | ArgenIS Titanium Abutments |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | Argen Corporation 5855 Oberlin Dr San Diego, CA 92121 |
| Contact | Paul Cascone |
| Correspondent | Maria Rao Sterngold Dental, LLC 23 Frank Mossberg Drive Attleboro, MA 02703 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-01 |
| Decision Date | 2016-08-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D818120079 | K160248 | 000 |
| D818120078 | K160248 | 000 |
| D818120077 | K160248 | 000 |
| D818120076 | K160248 | 000 |
| D818120075 | K160248 | 000 |
| D818120074 | K160248 | 000 |
| D818120073 | K160248 | 000 |