| Primary Device ID | 07392532290466 |
| NIH Device Record Key | 18990448-61ed-463f-b887-a0da5a18cbc4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SIMPLANT |
| Version Model Number | 37473 |
| Catalog Number | 37473 |
| Company DUNS | 344038836 |
| Company Name | Dentsply Implants Manufacturing GmbH |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07392532290466 [Primary] |
| NDP | Accessories, implant, dental, endosseous |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-03-06 |
| Device Publish Date | 2025-02-26 |
| 07392532279836 | C/Guide Sleeve 3.4 XND PrimeTaper/AstraTech Implant EV |
| 07392532290466 | Guide File FT review |
| 07392532290459 | Guide File DS design |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SIMPLANT 79016792 3171725 Live/Registered |
DENTSPLY Implants NV 2004-10-27 |
![]() SIMPLANT 77848515 3877954 Dead/Cancelled |
WomanCare Global LLC 2009-10-14 |