| Primary Device ID | 08800070219546 |
| NIH Device Record Key | 31995716-a6db-4dcc-a007-cad939312ccc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ball Abutment |
| Version Model Number | BATR3510 |
| Company DUNS | 694625347 |
| Company Name | Izenimplant Co., Ltd. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800070219546 [Primary] |
| NHA | Abutment, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08800070219546]
Moist Heat or Steam Sterilization
[08800070219546]
Moist Heat or Steam Sterilization
[08800070219546]
Moist Heat or Steam Sterilization
[08800070219546]
Moist Heat or Steam Sterilization
[08800070219546]
Moist Heat or Steam Sterilization
[08800070219546]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-05-18 |
| Device Publish Date | 2022-05-10 |
| 08800070219591 | BATR3560 |
| 08800070219584 | BATR3550 |
| 08800070219577 | BATR3540 |
| 08800070219560 | BATR3530 |
| 08800070219553 | BATR3520 |
| 08800070219546 | BATR3510 |
| 08800070219539 | BATM3560 |
| 08800070219522 | BATM3550 |
| 08800070219515 | BATM3540 |
| 08800070219508 | BATM3530 |
| 08800070219492 | BATM3520 |
| 08800070219485 | BATM3510 |
| 08800070219478 | BASR3560 |
| 08800070219461 | BASR3550 |
| 08800070219454 | BASR3540 |
| 08800070219447 | BASR3530 |
| 08800070219430 | BASR3520 |
| 08800070219423 | BASR3510 |