The following data is part of a premarket notification filed by Quadric Biomed, Llc with the FDA for Proximerge 2 Dental Implant System.
| Device ID | K211409 |
| 510k Number | K211409 |
| Device Name: | Proximerge 2 Dental Implant System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | Quadric BioMed, LLC 640 Southpointe Court #150 Colorado Springs, CO 80906 |
| Contact | Aaron Bass |
| Correspondent | Nathan Wright Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, CO 80918 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-06 |
| Decision Date | 2022-10-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D985KSG1050 | K211409 | 000 |
| D985KSG910 | K211409 | 000 |
| D985KTF910 | K211409 | 000 |
| D985KTF1050 | K211409 | 000 |
| D985KRS910 | K211409 | 000 |
| D985KRS1050 | K211409 | 000 |