This company has registrations in United States, Brazil, Saudi Arabia, Canada — 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 | K252890 | ZenSeal Pro | 2026-01-07 |
| US | K222830 | Rainbow 360 | 2023-01-12 |
| US | K221255 | SimpliShade Bulk Fill, SimpliShade Bulk Fill Flow | 2022-08-31 |
| BR | 10064019050 | NX3 Intro | Class II |
| BR | 10258190094 | BROCA DENTAL CARBIDE | Class I |
| BR | 10064010087 | POINT 4 | Class II |
| SA | ME0000000653SFDAA00069 | Hawe Stopstrip | — |
| SA | ME0000000654SFDAA00022 | Take 1 Advanced Putty | — |
| CA | 1760 | ROOT APEX LOCATOR | Class II |
| CA | 4417 | ROOT CANAL SEALER | Class III |
| CA | 4438 | GUTTA PERCHA | Class III |