The following data is part of a premarket notification filed by Simpler Implant, Inc. with the FDA for Simpler Ha Threaded, St 5002-8, Sit 5002-8, St 5011-st5014, St 5021-24.
| Device ID | K060376 |
| 510k Number | K060376 |
| Device Name: | SIMPLER HA THREADED, ST 5002-8, SIT 5002-8, ST 5011-ST5014, ST 5021-24 |
| Classification | Implant, Endosseous, Root-form |
| Applicant | SIMPLER IMPLANT, INC. 404-1023 WOLFE AVENUE Vancouver, Bc, CA V6h 1v6 |
| Contact | Karen Bergman |
| Correspondent | Karen Bergman SIMPLER IMPLANT, INC. 404-1023 WOLFE AVENUE Vancouver, Bc, CA V6h 1v6 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-14 |
| Decision Date | 2006-04-25 |