This company has registrations in United States, Saudi Arabia, Canada, Taiwan, Singapore, Australia, Russia — 7 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 | K250739 | Primeprint Direct Aligner | 2025-11-07 |
| US | K200580 | FotoDent denture | 2020-11-19 |
| US | K190571 | StoneBite and StoneBite scan | 2019-11-07 |
| SA | ME0000006484SFDAA00003 | FotoDent® tray | — |
| SA | ME0000006484SFDAA00005 | FotoDent® guide for CreoC5 | — |
| CA | 96039 | DRUFOSOFT PRIMER | Class II |