This company has registrations in United States, Brazil, Saudi Arabia, Taiwan, Singapore, South Korea, Australia, Israel, Russia — 9 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 | K243921 | LED Curing Lights (DB686 HALO) | 2025-04-11 |
| US | K220179 | High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors | 2023-09-22 |
| US | K220829 | Endo Motor | 2023-05-18 |
| BR | 81684349005 | Peça de Mão Contra Ângulo e Reta Plenum | Class II |
| BR | 82420419001 | PT MASTER - ULTRALIGHT | Class II |
| BR | 82176169014 | CANETA ODONTOLÓGICA DE ALTA ROTAÇÃO - COXO | Class II |
| SA | ME0000016179SFDAA00003 | LED Curing Light | — |
| SA | ME0000016179SFDAA00002 | Dental Aerosol Suction System | — |