| Primary Device ID | 08809986609601 |
| NIH Device Record Key | 6f26cd0f-7675-4c8d-b413-a93d68e56d6a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AMII Implant Healing Cap |
| Version Model Number | MP CAP4.5L |
| Company DUNS | 631169224 |
| Company Name | InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd) |
| 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 | true |
| 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 | 08809986609601 [Primary] |
| NHA | Abutment, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08809986609601]
Moist Heat or Steam Sterilization
[08809986609601]
Moist Heat or Steam Sterilization
[08809986609601]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-08-14 |
| Device Publish Date | 2025-08-06 |