| Primary Device ID | 05060967630042 | 
| NIH Device Record Key | 4ce8e009-489e-47aa-b0ed-0529441c5bcb | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Yomi One Implant System | 
| Version Model Number | 24012 | 
| Catalog Number | 24012 | 
| Company DUNS | 509583543 | 
| Company Name | Neoss AB | 
| 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 | false | 
| Manufacturing Date | false | 
| Expiration Date | true | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | true | 
| OTC Over-The-Counter | false | 
| Phone | 866 626 3677 | 
| marketingusa@neoss.com | |
| Phone | 866 626 3677 | 
| marketingusa@neoss.com | |
| Phone | 866 626 3677 | 
| marketingusa@neoss.com | |
| Phone | 866 626 3677 | 
| marketingusa@neoss.com | |
| Phone | 866 626 3677 | 
| marketingusa@neoss.com | |
| Phone | 866 626 3677 | 
| marketingusa@neoss.com | |
| Phone | 866 626 3677 | 
| marketingusa@neoss.com | |
| Phone | 866 626 3677 | 
| marketingusa@neoss.com | |
| Phone | 866 626 3677 | 
| marketingusa@neoss.com | |
| Phone | 866 626 3677 | 
| marketingusa@neoss.com | |
| Phone | 866 626 3677 | 
| marketingusa@neoss.com | |
| Phone | 866 626 3677 | 
| marketingusa@neoss.com | |
| Phone | 866 626 3677 | 
| marketingusa@neoss.com | |
| Phone | 866 626 3677 | 
| marketingusa@neoss.com | |
| Phone | 866 626 3677 | 
| marketingusa@neoss.com | |
| Phone | 866 626 3677 | 
| marketingusa@neoss.com | |
| Phone | 866 626 3677 | 
| marketingusa@neoss.com | |
| Phone | 866 626 3677 | 
| marketingusa@neoss.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 05060967630042 [Primary] | 
| DZE | Implant, Endosseous, Root-Form | 
| Steralize Prior To Use | false | 
| Device Is Sterile | true | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2024-02-23 | 
| Device Publish Date | 2024-02-15 | 
| 05060967630271 | Implant System Box | 
| 05060967630196 | Dental Implant Ø5.0 x 17 mm | 
| 05060967630189 | Dental Implant Ø5.0 x 15 mm | 
| 05060967630172 | Dental Implant Ø5.0 x 13 mm | 
| 05060967630165 | Dental Implant Ø5.0 x 11 mm | 
| 05060967630158 | Dental Implant Ø5.0 x 9 mm | 
| 05060967630141 | Dental Implant Ø4.5 x 17 mm | 
| 05060967630134 | Dental Implant Ø4.5 x 15 mm | 
| 05060967630127 | Dental Implant Ø4.5 x 13 mm | 
| 05060967630110 | Dental Implant Ø4.5 x 11 mm | 
| 05060967630103 | Dental Implant Ø4.5 x 9 mm | 
| 05060967630097 | Dental Implant Ø4.0 x 17 mm | 
| 05060967630080 | Dental Implant Ø4.0 x 15 mm | 
| 05060967630073 | Dental Implant Ø4.0 x 13 mm | 
| 05060967630066 | Dental Implant Ø4.0 x 11 mm | 
| 05060967630059 | Dental Implant Ø4.0 x 9 mm | 
| 05060967630042 | Dental Implant Ø3.5 x 17 mm | 
| 05060967630035 | Dental Implant Ø3.5 x 15 mm | 
| 05060967630028 | Dental Implant Ø3.5 x 13 mm | 
| 05060967630011 | Dental Implant Ø3.5 x 11 mm | 
| 05060967630004 | Dental Implant Ø3.5 x 9 mm |