| Primary Device ID | 10841307118794 |
| NIH Device Record Key | ef6b6dfd-01ca-46d7-a49f-0a9a7f34f340 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IMZ 4.0mm Titanium IMC - 1.0mm Abutment |
| Version Model Number | 57-8310CU |
| Catalog Number | 57-8310CU |
| Company DUNS | 868856969 |
| Company Name | IMPLANT DIRECT SYBRON MANUFACTURING LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 | 1-888-649-6425 |
| customerservice@implantdirect.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10841307118794 [Primary] |
| DZE | Implant, Endosseous, Root-Form |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10841307118794]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-11-08 |
| Device Publish Date | 2015-10-16 |
| 00841307129519 - Long Fixation Screw | 2024-03-20 |
| 00841307129526 - Dual-Grip™ Long Fixation Screw | 2024-03-20 |
| 00841307129533 - Dual-Grip™ Long Fixation Screw | 2024-03-20 |
| 00841307129540 - Long Fixation Screw | 2024-03-20 |
| 00841307129557 - Fixation Screw | 2024-03-20 |
| 00841307129571 - Duo-Grip™ Long Fixation Screw | 2024-03-20 |
| 00841307129588 - Duo-Grip™ Fixation Screw | 2024-03-20 |
| 00841307129595 - Duo-Grip™ Fixation Screw Extra Short | 2024-03-20 |