This company has registrations in United States, Brazil, Singapore, South Korea, Australia, Israel — 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 | K240337 | Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L) | 2024-11-13 |
| US | K240340 | Surgical Drive System (Model: ES70, ES90, E8) | 2024-07-18 |
| US | K170236 | Dental Low-speed Turbine Handpiece | 2017-11-21 |
| BR | 80117589080 | Peças de Mão de Baixa Rotação | Class II |
| BR | 80117589081 | Peça de mão de turbina odontológica de alta velocidade | Class II |