This company has registrations in United States, Brazil, Saudi Arabia, Taiwan, Singapore, Israel, 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 | K241074 | High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors (Straight Handpieces: SCHD05-S, SCHD16-S, SCHD17-S, SCHD24-S, SCHD27-S Geared Angle Handpieces: SCHD05-C, SCHD06-C, SCHD16-C, SCHD17-C, SCHD24-C, SCHD27-C, SCHD29-S, SCHB4, SCHB5, SCHB20, SCHB64 Air Motors: SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M) | 2024-11-12 |
| BR | 80348969013 | Peças de Mão de Baixa Rotação - Peça Reta | Class II |
| BR | 80348969010 | Peças de Mão de Alta Rotação | Class II |
| BR | 80348969011 | Peças de Mão de Baixa Rotação - Contra Ângulo | Class II |
| SA | ME0000003761SFDAA00002 | Dental Root Canal Instrument | — |
| SA | ME0000007785SFDAA00009 | Endodontic hand files | — |