| Primary Device ID | 08809708759256 | 
| NIH Device Record Key | ae2416b2-a7ad-4941-bae5-179ffbf96434 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Scan Abutment | 
| Version Model Number | AROCSS3810R | 
| Catalog Number | AROCSS3810RT | 
| Company DUNS | 687388178 | 
| Company Name | Megagen Implant Co. Ltd | 
| Device Count | 1 | 
| DM Exempt | false | 
| Pre-market Exempt | true | 
| 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 | 08809708759256 [Primary] | 
| NDP | Accessories, Implant, Dental, Endosseous | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[08809708759256]
Moist Heat or Steam Sterilization
[08809708759256]
Moist Heat or Steam Sterilization
[08809708759256]
Moist Heat or Steam Sterilization
[08809708759256]
Moist Heat or Steam Sterilization
[08809708759256]
Moist Heat or Steam Sterilization
[08809708759256]
Moist Heat or Steam Sterilization
[08809708759256]
Moist Heat or Steam Sterilization
[08809708759256]
Moist Heat or Steam Sterilization
[08809708759256]
Moist Heat or Steam Sterilization
[08809708759256]
Moist Heat or Steam Sterilization
[08809708759256]
Moist Heat or Steam Sterilization
[08809708759256]
Moist Heat or Steam Sterilization
[08809708759256]
Moist Heat or Steam Sterilization
[08809708759256]
Moist Heat or Steam Sterilization
[08809708759256]
Moist Heat or Steam Sterilization
[08809708759256]
Moist Heat or Steam Sterilization
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2023-07-05 | 
| Device Publish Date | 2023-06-27 | 
| 08809708759164 | BLUEDIAMOND Implant System Scan Abutment Ø5.5/ C=2/ L/ C-type/ RC | 
| 08809708759157 | BLUEDIAMOND Implant System Scan Abutment Ø5.5/ C=1/ L/ C-type/ RC | 
| 08809708759140 | BLUEDIAMOND Implant System Scan Abutment Ø5.5/ C=0.5/ L/ C-type/ RC | 
| 08809708759942 | BLUEDIAMOND Implant System Ø3.9/ C=0.5/ S/ C-type/ NC | 
| 08809708759270 | BLUEDIAMOND Implant System Ø4.3/ C=2/ S/ C-type/ RC | 
| 08809708759263 | BLUEDIAMOND Implant System Ø4.3/ C=2/ S/ C-type/ NC | 
| 08809708759256 | BLUEDIAMOND Implant System Ø4.3/ C=1/ S/ C-type/ RC | 
| 08809708759249 | BLUEDIAMOND Implant System Ø4.3/ C=1/ S/ C-type/ NC | 
| 08809708759232 | BLUEDIAMOND Implant System Ø4.3/ C=0.5/ S/ C-type/ RC | 
| 08809708759225 | BLUEDIAMOND Implant System Ø4.3/ C=0.5/ S/ C-type/ NC | 
| 08809708759218 | BLUEDIAMOND Implant System Ø3.9/ C=2/ S/ C-type/ RC | 
| 08809708759201 | BLUEDIAMOND Implant System Ø3.9/ C=2/ S/ C-type/ NC | 
| 08809708759195 | BLUEDIAMOND Implant System Ø3.9/ C=1/ S/ C-type/ RC | 
| 08809708759188 | BLUEDIAMOND Implant System Ø3.9/ C=1/ S/ C-type/ NC | 
| 08809708759171 | BLUEDIAMOND Implant System Ø3.9/ C=0.5/ S/ C-type/ RC | 
| 08806388242672 | ST Internal Implant System Ø4/ L=13/ R | 
| 08806388242665 | ST Internal Implant System Ø4/ L=13/ M | 
| 08806388266609 | AMUASR4013 | 
| 08806388256617 | AROSAR | 
| 08806388256600 | AROSAN | 
| 08806388244300 | MISS3509 | 
| 08806388242658 | OSGSSC3110 | 
| 08806388242641 | OSGSSC3210 | 
| 08806388207114 | AMEISR4013 | 
| 08809931183484 | ARi ExCon Implant System | 
| 08809931183477 | ARi ExCon Implant System | 
| 08809854029753 | ARi ExCon Implant System | 
| 08809854029746 | ARi ExCon Implant System | 
| 08800293004288 | Ø4/ L=13 | 
| 08800293000907 | Ø4/ C=3 | 
| 08800293000891 | Ø4/ C=3 |