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 | K210349 | TKO Composite Bite Turbo Gel | 2021-07-20 |
| US | K210945 | Ultra SEP | 2021-07-08 |
| US | K193388 | GlassLok Kits, GlassLok Powder, GlassLok Liquid | 2020-04-27 |
| BR | 80743689002 | ASSURE PLUS | Class II |
| BR | 80743689003 | Renew Finishing System Burs | Class II |
| BR | 80743689004 | Bond Aligner 1.4g Clear Aligner Adhesive | Class II |
| SA | ME0000012253SFDAA00001 | AC-Powered Ophthalmic Instruments Stand | — |
| SA | ME0000012253SFDAA00005 | Low voltage control chair | — |
| CA | 72322 | ENHANCE - ORTHODONTIC CONDITIONER | Class II |
| CA | 83496 | QUICK CURE | Class II |
| CA | 83500 | CUSTOM IQ | Class II |