| Primary Device ID | 08809931180704 |
| NIH Device Record Key | f570b661-cc1e-4fe7-a653-80f077d1fcf6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ZrGEN Abutment |
| Version Model Number | BDZGNB4048 |
| Catalog Number | BDZGNB4048.MTN |
| Company DUNS | 687388178 |
| Company Name | Megagen Implant 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 | true |
| Manufacturing Date | true |
| 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 | 08809931180704 [Primary] |
| NHA | Abutment, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08809931180704]
Moist Heat or Steam Sterilization
[08809931180704]
Moist Heat or Steam Sterilization
[08809931180704]
Moist Heat or Steam Sterilization
[08809931180704]
Moist Heat or Steam Sterilization
[08809931180704]
Moist Heat or Steam Sterilization
[08809931180704]
Moist Heat or Steam Sterilization
[08809931180704]
Moist Heat or Steam Sterilization
[08809931180704]
Moist Heat or Steam Sterilization
[08809931180704]
Moist Heat or Steam Sterilization
[08809931180704]
Moist Heat or Steam Sterilization
[08809931180704]
Moist Heat or Steam Sterilization
[08809931180704]
Moist Heat or Steam Sterilization
[08809931180704]
Moist Heat or Steam Sterilization
[08809931180704]
Moist Heat or Steam Sterilization
[08809931180704]
Moist Heat or Steam Sterilization
[08809931180704]
Moist Heat or Steam Sterilization
[08809931180704]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-02-05 |
| Device Publish Date | 2024-01-26 |
| 08806388208401 | Common Ø6.5/ C=0.8/ P=5/ Wide/ Octa |
| 08806388208395 | Common Ø5/ C=0.8/ P=5/ Small/ Octa |
| 08806388208388 | Common Ø5.5/ C=0.8/ P=5/ Regular/ Octa |
| 08806388204595 | AnyOne Internal Ø4.4/ C=1.5/ P=4.5 |
| 08806388204564 | AnyOne Internal Ø4/ C=0.6/ P=4.5 |
| 08809708759577 | XPEED AnyRidge Internal Implant System Ø4.5/ C=1.5/ P=6/ Non-Hex/ Core3.3 |
| 08809708759560 | XPEED AnyRidge Internal Implant System Ø4.5/ C=1.5/ P=6/ Core3.3 |
| 08806388245031 | MiNi Internal Implant System Ø3/ C=0.6/ P=2.5 |
| 08806388244805 | XPEED AnyRidge Internal Implant System Ø4.5/ C=1.5/ P=6/ Non-Hex/ Core3.3 |
| 08806388261161 | BLUEDIAMOND Implant System Ø5.5/ C=2/ L/ RC/ C-type |
| 08806388261154 | BLUEDIAMOND Implant System Ø5.5/ C=1/ L/ RC/ C-type |
| 08806388261147 | BLUEDIAMOND Implant System Ø5.5 C=0.5/ L/ RC/ C-type |
| 08806388261123 | BLUEDIAMOND Implant System Ø4.3/ C=1/ S/ RC/ C-type |
| 08806388261116 | BLUEDIAMOND Implant System Ø4.3/ C=0.5/ S/ RC/ C-type |
| 08806388261109 | BLUEDIAMOND Implant System Ø3.9/ C=2/ S/ RC/ C-type |
| 08806388261093 | BLUEDIAMOND Implant System Ø3.9/ C=1/ S/ RC/ C-type |
| 08806388261086 | BLUEDIAMOND Implant System Ø3.9/ C=0.5/ S/ RC/ C-type |
| 08806388261079 | BLUEDIAMOND Implant System Ø4.3/ C=2/ S/ NC/ C-type |
| 08806388261062 | BLUEDIAMOND Implant System Ø4.3/ C=1/ S/ NC/ C-type |
| 08806388261055 | BLUEDIAMOND Implant System Ø4.3/ C=0.5/ S/ NC/ C-type |
| 08806388261048 | BLUEDIAMOND Implant System Ø3.9/ C=2/ S/ NC/ C-type |
| 08806388261031 | BLUEDIAMOND Implant System Ø3.9/ C=1/ S/ NC/ C-type |
| 08806388261024 | BLUEDIAMOND Implant System Ø3.9/ C=0.5/ S/ NC/ C-type |
| 08806388260898 | BLUEDIAMOND Implant System Ø5.5/ C=2/ L/ RC/ C-type |
| 08806388260881 | BLUEDIAMOND Implant System Ø5.5/ C=1/ L/ RC/ C-type |
| 08806388260874 | BLUEDIAMOND Implant System Ø5.5 C=0.5/ L/ RC/ C-type |
| 08806388260850 | BLUEDIAMOND Implant System Ø4.3/ C=1/ S/ RC/ C-type |
| 08806388260843 | BLUEDIAMOND Implant System Ø4.3/ C=0.5/ S/ RC/ C-type |
| 08806388260836 | BLUEDIAMOND Implant System Ø3.9/ C=2/ S/ RC/ C-type |
| 08806388260829 | BLUEDIAMOND Implant System Ø3.9/ C=1/ S/ RC/ C-type |
| 08806388260812 | BLUEDIAMOND Implant System Ø3.9/ C=0.5/ S/ RC/ C-type |
| 08806388260805 | BLUEDIAMOND Implant System Ø4.3/ C=2/ S/ NC/ C-type |
| 08806388260799 | BLUEDIAMOND Implant System Ø4.3/ C=1/ S/ NC/ C-type |
| 08806388260782 | BLUEDIAMOND Implant System Ø4.3/ C=0.5/ S/ NC/ C-type |
| 08806388260775 | BLUEDIAMOND Implant System Ø3.9/ C=2/ S/ NC/ C-type |
| 08806388260768 | BLUEDIAMOND Implant System Ø3.9/ C=1/ S/ NC/ C-type |
| 08806388260751 | BLUEDIAMOND Implant System Ø3.9/ C=0.5/ S/ NC/ C-type |
| 08806388245383 | XPEED AnyRidge Internal Implant System Ø5.5/ C=2/ L/ C-type |
| 08806388245376 | XPEED AnyRidge Internal Implant System Ø5.5/ C=1/ L/ C-type |
| 08806388245369 | XPEED AnyRidge Internal Implant System Ø5.5/ C=0.5/ L/ C-type |
| 08806388245352 | XPEED AnyRidge Internal Implant System Ø4.3/ C=2/ S/ C-type |
| 08806388245345 | XPEED AnyRidge Internal Implant System Ø4.3/ C=1/ S/ C-type |
| 08806388245338 | XPEED AnyRidge Internal Implant System Ø4.3/ C=0.5/ S/ C-type |
| 08806388245321 | XPEED AnyRidge Internal Implant System Ø3.9/ C=2/ S/ C-type |
| 08806388245314 | XPEED AnyRidge Internal Implant System Ø3.9/ C=1/ S/ C-type |
| 08806388245307 | XPEED AnyRidge Internal Implant System Ø3.9/ C=0.5/ S/ C-type |
| 08806388245291 | AnyOne Internal & ST Implant System Ø5.5/ C=2/ L/ C-type |
| 08806388245284 | AnyOne Internal & ST Implant System Ø5.5/ C=1/ L/ C-type |
| 08806388245277 | AnyOne Internal & ST Implant System Ø5.5/ C=0.5/ L/ C-type |
| 08806388245260 | AnyOne Internal & ST Implant System Ø4.3/ C=2/ S/ C-type |