Registered with FDA
Csy International LLC
Rancho Cucamonga, CA, United States. Lists 26 dental device types with FDA across 1 registered establishment.
- Device types listed
- 26
- Brands and models
- 57
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What Csy International LLC currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Resin Bracket and Tooth Conditioner AdhesiveDYH · Class 2 | — | Lister | J&J ORTHODONTICS | 2022 |
| Orthodontic Ceramic BracketNJM · Class 2 | Orthodontic brackets | Lister | ClaroJ&J OrthoJ&J ORTHODONTICSNIEVE | 2020 |
| Orthodontic Screw Expansion RetainerDYJ · Class 1 | Retainers, expanders & headgear | Lister | J&J OrthoJ&J Orthodontics | 2020 |
| Orthodontic Material BandDYO · Class 1 | Orthodontic wires & bands | Lister | CaberJ&J OrthoJ&J Orthodontics | 2020 |
| Orthodontic Space Preformed MaintainerDYT · Class 1 | Retainers, expanders & headgear | Lister | J&J OrthoJ&J Orthodontics | 2020 |
| Orthodontic Extraoral HeadgearDZB · Class 2 | Retainers, expanders & headgear | Lister | J&J ORTHODONTICS | 2022 |
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Lister | J&J OrthoJ&J Orthodontics | 2020 |
| Orthodontic TubeDZD · Class 1 | Orthodontic wires & bands | Lister | J&J OrthoJ&J Orthodontics | 2020 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Lister | J&J ORTHODONTICS | 2022 |
| Ultraviolet Activator for PolymerizationEBZ · Class 2 | Curing lights | Lister | CICADAJ&J ORTHODONTICS | 2022 |
| Orthodontic Elastic BandECI · Class 1 | Orthodontic wires & bands | Lister | CaberJ&J OrthoJ&J Orthodontics | 2020 |
| Orthodontic Preformed BandECM · Class 1 | Orthodontic wires & bands | Lister | CaberJ&J OrthoJ&J Orthodontics | 2020 |
| Orthodontic Wire ClampECN · Class 1 | — | Lister | J&J OrthoJ&J Orthodontics | 2020 |
| Orthodontic SpringECO · Class 1 | Orthodontic wires & bands | Lister | J&J OrthoJ&J Orthodontics | 2020 |
| Orthodontic Ligature Tucking InstrumentECP · Class 1 | Dental hand instruments | Lister | J&J OrthoJ&J Orthodontics | 2020 |
| Orthodontic Bracket AlignerECQ · Class 1 | Dental hand instruments | Lister | J&J OrthoJ&J Orthodontics | 2020 |
| Orthodontic Band SetterECR · Class 1 | Dental hand instruments | Lister | J&J OrthoJ&J Orthodontics | 2020 |
| Orthodontic Band PusherECS · Class 1 | Dental hand instruments | Lister | J&J OrthoJ&J Orthodontics | 2020 |
| Orthodontic Band DriverECT · Class 1 | Dental hand instruments | Lister | J&J OrthoJ&J Orthodontics | 2020 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Lister | J&J ORTHODONTICS | 2022 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Lister | J&J ORTHODONTICS | 2022 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Lister | BeaconDoradaJ&J OrthoJ&J OrthodonticsPrecisaPrecisa IISigiloSuaveVeloz | 2020 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Lister | J&J ORTHODONTICS | 2022 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Lister | J&J OrthoJ&J Orthodontics | 2020 |
| Resin ApplicatorKXR · Class 1 | — | Lister | J&J ORTHODONTICS | 2022 |
| Orthodontic Endosseous ImplantOAT · Class 2 | — | Lister | GNIJ&J Orthodontics | 2020 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Csy International LLC lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: GNI Co., LTD (3), Ortho Source (3), Foshan Cicada Dental Instrument Co, Ltd. (1), KJ Meditech Co., Ltd. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 12 Mar 2021 | K201410 | VENUS Bracket, ROSE Bracket | GNI Co., LTD | NJM Orthodontic Ceramic Bracket |
| 28 Aug 2020 | K191041 | Orthodontic Fixation Screw [Smart Anchor Miniscrew] | GNI Co., LTD | OAT Orthodontic Endosseous Implant |
| 13 Feb 2020 | K192233 | LED Curing Light | Foshan Cicada Dental Instrument Co, Ltd. | EBZ Ultraviolet Activator for Polymerization |
| 15 Nov 2019 | K182672 | ROSA Bracket | GNI Co., LTD | NJM Orthodontic Ceramic Bracket |
| 9 Jun 2011 | K103019 | KJ MASK | KJ Meditech Co., Ltd. | DZB Orthodontic Extraoral Headgear |
| 14 Jan 1992 | K913854 | ORTHO LIGHT CURE | Ortho Source | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 17 Apr 1986 | K861258 | PERMABAND (ORTHODONTIC ADHESIVE) | Ortho Source | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 25 Mar 1986 | K860959 | DEPENDABOND | Ortho Source | DYH Resin Bracket and Tooth Conditioner Adhesive |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| CSY INTERNATIONAL LLCFDA reg. 3016543896 | Rancho Cucamonga, CA, United States | Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10062340). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.