| Primary Device ID | 07290112280008 |
| NIH Device Record Key | 5c827d99-f4fa-457b-acbc-f54fcb69829b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Surgical Kit |
| Version Model Number | SK-2000 |
| Company DUNS | 514897185 |
| Company Name | DENTACK IMPLANTS LTD |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +97297660379 |
| info@pyramidion-is.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290112280008 [Primary] |
| OFY | Dental Implant Surgical Tray |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07290112280008]
Dry Heat Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-03-04 |
| Device Publish Date | 2018-02-23 |
| 07290112280831 - Expansion tool-screw 6.35+wrench short - Assy | 2019-12-20 Expansion tool-screw 6.35+wrench short - Assy |
| 07290112280855 - Expansion tool EX-screw+wrench short - Assy | 2019-12-20 Expansion tool EX-screw+wrench short - Assy |
| 07290112280664 - Implant 4.1*5 | 2019-03-11 Implant 4.1*5 |
| 07290112280671 - Straight MU Abutment | 2019-03-11 Straight MU Abutment |
| 07290112280688 - Multi Unit Abutment for EX | 2019-03-11 Multi Unit Abutment for EX |
| 07290112280695 - Straight MU Abutment | 2019-03-11 Straight MU Abutment |
| 07290112280701 - Multi Unit Abutment for EX | 2019-03-11 Multi Unit Abutment for EX |
| 07290112280718 - Straight MU Abutment | 2019-03-11 Straight MU Abutment |