| Primary Device ID | 10841307118787 |
| NIH Device Record Key | 67ff8d31-60a3-4f79-b885-be43095db6c5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IMZ 4.0mm Titanium IME - 4mm Abutment |
| Version Model Number | 57-8288TU |
| Catalog Number | 57-8288TU |
| 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 | 10841307118787 [Primary] |
| DZE | Implant, Endosseous, Root-Form |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10841307118787]
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 |
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| 10841307111641 - Legacy™ Plastic Engaging Temporary Abutment | 2024-12-23 |
| 10841307111696 - Legacy™ Plastic Temporary Abutment | 2024-12-23 |
| 10841307103585 - ReActive® Implant | 2024-12-20 Ø3.7 x 8 Platform 3.5mmD |
| 10841307103592 - ReActive® Implant | 2024-12-20 Ø3.7 x 8 Platform 3.5mmD |
| 10841307103608 - ReActive® Implant | 2024-12-20 Ø3.7 x 8 Platform 3.5mmD |
| 10841307103615 - ReActive® Implant | 2024-12-20 Ø3.7 x 8 Platform 3.5mmD |