| Primary Device ID | 08800293009122 |
| NIH Device Record Key | 5a077560-6bf1-4047-a8ef-507eecdb7842 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Impression Coping |
| Version Model Number | AXICPS504S |
| Catalog Number | AXICPS504ST |
| 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 | 08800293009122 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08800293009122]
Moist Heat or Steam Sterilization
[08800293009122]
Moist Heat or Steam Sterilization
[08800293009122]
Moist Heat or Steam Sterilization
[08800293009122]
Moist Heat or Steam Sterilization
[08800293009122]
Moist Heat or Steam Sterilization
[08800293009122]
Moist Heat or Steam Sterilization
[08800293009122]
Moist Heat or Steam Sterilization
[08800293009122]
Moist Heat or Steam Sterilization
[08800293009122]
Moist Heat or Steam Sterilization
[08800293009122]
Moist Heat or Steam Sterilization
[08800293009122]
Moist Heat or Steam Sterilization
[08800293009122]
Moist Heat or Steam Sterilization
[08800293009122]
Moist Heat or Steam Sterilization
[08800293009122]
Moist Heat or Steam Sterilization
[08800293009122]
Moist Heat or Steam Sterilization
[08800293009122]
Moist Heat or Steam Sterilization
[08800293009122]
Moist Heat or Steam Sterilization
[08800293009122]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-05-19 |
| Device Publish Date | 2025-05-09 |
| 08806388239696 | ExFeel External Ø5.8/ L=12/ Hex/ Pick-up/ Wide |
| 08806388239689 | ExFeel External Ø5.8/ L=12/ Hex/ Pick-up/ Wide |
| 08806388239597 | ExFeel External Ø5.8/ L=13/ Non-Hex/ Transfer/ Wide |
| 08806388239580 | ExFeel External Ø5.8/ L=13/ Hex/ Transfer/ Wide |
| 08806388235827 | ExFeel External M1.6/ Pick-up/ Hex |
| 08806388235537 | ExFeel External Ø4.8/ L=13/ Non-Hex/ Transfer/ Small |
| 08806388235520 | ExFeel External Ø4.8/ L=13/ Hex/ Transfer/ Small |
| 08806388232918 | ExFeel External Ø6/ L=12/ Non-Hex/ Pick-up |
| 08806388232901 | ExFeel External Ø5/ L=12/ Non-Hex/ Pick-up |
| 08806388232895 | ExFeel External Ø6/ L=12/ Hex/ Pick-up |
| 08806388232888 | ExFeel External Ø5/ L=12/ Hex/ Pick-up |
| 08806388232871 | ExFeel External Ø5/ L=12/ Hex/ Pick-up |
| 08806388232826 | Rescue External Ø5.5/ L=8/ Transfer/ Widecone |
| 08806388232819 | ExFeel External Ø4.5/ L=9/ Transfer/ Standard |
| 08806388232802 | ExFeel External Ø4.8/ L=8/ Transfer/ Esthetic |
| 08806388232796 | ExFeel External Ø4.8/ L=10/ Non-Octa/ Pick-up |
| 08806388232789 | ExFeel External Ø4.8/ L=10/ Octa/ Pick-up |
| 08806388232758 | ExFeel External Non-Hex/ Pick-up/ Esthetic |
| 08806388232741 | ExFeel External Hex/ Pick-up/ Esthetic |
| 08806388232567 | ExFeel External Ø4.8/ L=13/ Non-Hex/ Transfer/ Regular |
| 08806388232550 | ExFeel External Ø4.8/ L=13/ Non-Trip/ Transfer |
| 08806388232543 | ExFeel External Ø4.8/ L=13/ Hex/ Transfer/ Regular |
| 08806388232536 | ExFeel External Ø4.8/ L=13/ Trip/ Transfer |
| 08806388227099 | MiNi Internal Ø3.5/ L=16/ Non-Hex/ Transfer |
| 08806388227082 | MiNi Internal Ø3.5/ L=16/ Hex/ Transfer |
| 08806388227075 | MiNi Internal Ø3.5/ L=12/ Non-Hex/ Transfer |
| 08806388227068 | MiNi Internal Ø3.5/ L=12/ Hex/ Transfer |
| 08806388227051 | MiNi Internal Ø3.5/ L=16/ Non-Hex/ Pick-up |
| 08806388227044 | MiNi Internal Ø3.5/ L=16/ Hex/ Pick-up |
| 08806388227037 | MiNi Internal Ø3.5/ L=12/ Non-Hex/ Pick-up |
| 08806388227020 | MiNi Internal Ø3.5/ L=12/ Hex/ Pick-up |
| 08806388225101 | Rescue External Ø5.8/ L=12/ Non-Hex/ Pick-up |
| 08806388225095 | Rescue External Ø5.8/ L=12/ Hex/ Pick-up |
| 08806388225064 | Rescue External Ø5.8/ L=13/ Non-Hex/ Transfer |
| 08806388225057 | Rescue External Ø5.8/ L=13/ Hex/ Transfer |
| 08806388223787 | AnyOne Internal Ø6.5/ L=16/ Non-Hex/ Transfer |
| 08806388223770 | AnyOne Internal Ø6.5/ L=16/ Non-Hex/ Transfer |
| 08806388223763 | AnyOne Internal Ø6.5/ L=16/ Hex/ Transfer |
| 08806388223749 | AnyOne Internal Ø6.5/ L=12/ Non-Hex/ Transfer |
| 08806388223732 | AnyOne Internal Ø6.5/ L=12/ Non-Hex/ Transfer |
| 08806388223725 | AnyOne Internal Ø6.5/ L=12/ Hex/ Transfer |
| 08806388223701 | AnyOne Internal Ø5.5/ L=16/ Non-Hex/ Transfer |
| 08806388223695 | AnyOne Internal Ø5.5/ L=16/ Non-Hex/ Transfer |
| 08806388223688 | AnyOne Internal Ø5.5/ L=16/ Hex/ Transfer |
| 08806388223664 | AnyOne Internal Ø5.5/ L=12/ Non-Hex/ Transfer |
| 08806388223657 | AnyOne Internal Ø5.5/ L=12/ Non-Hex/ Transfer |
| 08806388223640 | AnyOne Internal Ø5.5/ L=12/ Hex/ Transfer |
| 08806388223626 | AnyOne Internal Ø4.5/ L=16/ Non-Hex/ Transfer |
| 08806388223619 | AnyOne Internal Ø4.5/ L=16/ Non-Hex/ Transfer |
| 08806388223602 | AnyOne Internal Ø4.5/ L=16/ Hex/ Transfer |