This company has registrations in United States, Brazil, Australia, Russia — 4 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 | K213947 | Ultrasonic Endo Activation Device (Model:Actor I pro) | 2022-09-08 |
| US | K203836 | BOMEDENT Apex locator, WISMY Apex locator | 2021-03-30 |
| US | K191276 | Dental Electrical Motor iRoot Pro | 2020-06-30 |
| BR | 81504799097 | Localizador de vértice | Class II |
| BR | 81504799098 | Endo motor para preparação do canal radicular | Class II |
| BR | 81504799099 | Dispositivo de Ativação Endo Ultrassônica | Class II |