This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia — 6 overseas markets. The China NMPA lookup is still pending.
Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.
Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.
| Market | Identifier | Name | Class / date |
|---|---|---|---|
| US | K210039 | CORE1 Implant System | 2022-01-07 |
| US | K113543 | ONDEMAND3D | 2011-12-16 |
| US | K070464 | ONDEMAND3D | 2007-03-16 |
| BR | 10064010268 | OnDemand3D | Class II |
| CA | 89380 | ONDEMAND3D (PICTURE ARCHIVING COMMUNICATIONS SYSTEM) | Class II |