| Primary Device ID | 10841307119012 |
| NIH Device Record Key | d2788c64-4278-41c0-aa7a-61c6563d1ec5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | simplyCrown&Bridge RePlant® |
| Version Model Number | 6035-23K |
| Catalog Number | 6035-23K |
| 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 | true |
| 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 Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10841307119012 [Primary] |
| NHA | Abutment, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10841307119012]
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 |
| 10841307119104 | 6060-23K |
| 10841307119098 | 6060-22K |
| 10841307119081 | 6060-21K |
| 10841307119074 | 6050-23K |
| 10841307119067 | 6050-22K |
| 10841307119050 | 6050-21K |
| 10841307119043 | 6043-23K |
| 10841307119036 | 6043-22K |
| 10841307119029 | 6043-21K |
| 10841307119012 | 6035-23K |
| 10841307119005 | 6035-22K |
| 10841307118992 | 6035-21K |