| Primary Device ID | 08806388260515 |
| NIH Device Record Key | 60208503-a066-458d-9b1f-3f17b85135cc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AbutmentScrew |
| Version Model Number | AROAS16 |
| Catalog Number | AROAS16 |
| Company DUNS | 687388178 |
| Company Name | Megagen 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 | 08806388260515 [Primary] |
| NHA | Abutment, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08806388260515]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-11-27 |
| Device Publish Date | 2019-11-19 |
| 08809708751595 - ZrGEN Abutment | 2025-03-24 Ø4/ C=3/ P=8/ Small |
| 08809708751601 - ZrGEN Abutment | 2025-03-24 Ø4/ C=3/ P=8/ Small/ Non-Hex |
| 08809708751618 - ZrGEN Abutment | 2025-03-24 Ø4/ C=4/ P=4.5/ Small |
| 08809708751809 - ZrGEN Abutment | 2025-03-24 Ø4/ C=3/ P=8/ Regular/ Non-Hex |
| 08809708751816 - ZrGEN Abutment | 2025-03-24 Ø4/ C=4/ P=4.5/ Regular |
| 08809708751823 - ZrGEN Abutment | 2025-03-24 Ø4/ C=4/ P=4.5/ Regular/ Non-Hex |
| 08806388245437 - ZrGEN Abutment | 2025-03-14 Ø4.3/ C=1/ S/ C-type |
| 08806388245444 - ZrGEN Abutment | 2025-03-14 Ø4.3/ C=2/ S/ C-type |