Recognized a 510(k)/PMA number — showing its clearance record and devices.
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Swish™ Overdenture Abutment | 9048-64 | IMPLANT DIRECT SYBRON MANUFACTURING LLC | NHA | 10841307116349 |
| Swish™ Healing Collar | 9048-15 | IMPLANT DIRECT SYBRON MANUFACTURING LLC | NHA | 10841307116172 |
| SwishPlus® Implant | 924810 | IMPLANT DIRECT SYBRON MANUFACTURING LLC | DZE | 10841307106203 |
| Swish™ Countersink Drill | SPCD4-6 | IMPLANT DIRECT SYBRON MANUFACTURING LLC | DZI | 10841307117339 |
| Swish™ Angled Overdenture Multi-Unit Abutment | 9048-64-15S | IMPLANT DIRECT SYBRON MANUFACTURING LLC | NHA | 10841307127048 |
| Step Drill Short (6-10mml) | SD2.3S | IMPLANT DIRECT SYBRON MANUFACTURING LLC | DZI | 10841307117230 |
| Straight Abutment Comfort Cap (2 pieces) | 3057-26 | IMPLANT DIRECT SYBRON MANUFACTURING LLC | NHA | 10841307115083 |
| Step Drill (6-16mml) | SD4.4 | IMPLANT DIRECT SYBRON MANUFACTURING LLC | DZI | 10841307117186 |
| Cortical Bone Drill for 7.0mmD Implant | CBD7.0 | IMPLANT DIRECT SYBRON MANUFACTURING LLC | DZI | 10841307117049 |
| Swish™ Ball Abutment | 9048-71 | IMPLANT DIRECT SYBRON MANUFACTURING LLC | NHA | 10841307115687 |
| SwishPlant® Implant | 904814 | IMPLANT DIRECT SYBRON MANUFACTURING LLC | DZE | 10841307105961 |
| Swish™ Overdenture Abutment | 9048-61 | IMPLANT DIRECT SYBRON MANUFACTURING LLC | NHA | 10841307116318 |
| Swish™ Healing Collar | 9048-14 | IMPLANT DIRECT SYBRON MANUFACTURING LLC | NHA | 10841307116165 |
| Swish™ Healing Collar | 9037-14 | IMPLANT DIRECT SYBRON MANUFACTURING LLC | NHA | 10841307116127 |
| SwishPlus® Implant | 924112 | IMPLANT DIRECT SYBRON MANUFACTURING LLC | DZE | 10841307106159 |
| Replant Soft Bone Step Drill | RSB4 | IMPLANT DIRECT SYBRON MANUFACTURING LLC | DZI | 10841307117070 |
| Swish™ Multi-Unit Abutment | 9048-62 | IMPLANT DIRECT SYBRON MANUFACTURING LLC | NHA | 10841307127314 |
| Swish™ Straight Drill (6-16mmL) | SPD5.1 | IMPLANT DIRECT SYBRON MANUFACTURING LLC | DZI | 10841307117438 |
| Swish™ Countersink Drill | SPCD4.8 | IMPLANT DIRECT SYBRON MANUFACTURING LLC | DZI | 10841307117353 |
| Step Drill (6-16mml) | SD3.8 | IMPLANT DIRECT SYBRON MANUFACTURING LLC | DZI | 10841307117179 |
| Swish™ Ball Abutment | 9048-74 | IMPLANT DIRECT SYBRON MANUFACTURING LLC | NHA | 10841307115717 |
| Swish™ Straight Abutment | 9048-21 | IMPLANT DIRECT SYBRON MANUFACTURING LLC | NHA | 10841307116400 |
| Step Drill Short (6-10mml) | SD3.8S | IMPLANT DIRECT SYBRON MANUFACTURING LLC | DZI | 10841307117261 |
| Swish™ Healing Collar Narrow | 9048-13N | IMPLANT DIRECT SYBRON MANUFACTURING LLC | NHA | 10841307116233 |
| Swish™ Overdenture Abutment | 9048-62 | IMPLANT DIRECT SYBRON MANUFACTURING LLC | NHA | 10841307116325 |