Manufacturer registered with FDA
Henan Lusterdent Medical Instrument Co.,Ltd
Zhengzhou, China. Lists 14 dental device types with FDA across 1 registered establishment.
- Device types listed
- 14
- Brands and models
- 25
- 510(k) clearances
- 0as applicant
- Markets registered in
- 58 registrations outside the US
- Establishments
- 1China
Registered in 5 markets
Where regulators' registries name Henan Lusterdent Medical Instrument Co.,Ltd as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Henan Lusterdent Medical Instrument Co.,Ltd | 14 device types | — | Below |
| Australia | TGA | Manufacturer | Henan Lusterdent Medical Instrument Co Ltd | 3 | 2018–2025 | Pure Global AI |
| Israel | AMAR | Manufacturer | Henan Lusterdent Medical Instrument Co., Ltd | 2 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Henan Lusterdent Medical Instrument Co., Ltd. | 2 | 2021–2021 | Pure Global AI |
| Hong Kong | MDD | Manufacturer | Henan Lusterdent Medical Instrument Co., Ltd | 1 | 2025–2025 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Henan Lusterdent Medical Instrument Co.,Ltd currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | Endodontic Enlarger Drills/ Gates Drills / Dental Post Drills / Peeso Reamers / Fiber Post Drills | 2024 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | Endo Motor / Rotary Motor / Endodontic Apex Locator. | 2024 |
| Air and/or Water Syringe UnitECB · Class 1 | Dental hand instruments | Maker | Air Water Syringe Tips / Air Water Syringe Adapter Unit | 2015 |
| Articulation PaperEFH · Class 1 | — | Maker | Articulating Paper | 2015 |
| Prophylaxis CupEHK · Class 1 | Polishing & prophylaxis | Maker | Prophy Brushes and Cups | 2015 |
| Abrasive PointEHL · Class 1 | Polishing & prophylaxis | Maker | Abrasive Diamond Strips | 2015 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | Dental Burs ( Carbide Burs / Finishing Carbide Burs / Surgical Carbide Burs / Crown Cutter Burs )Dental Burs ( Diamond Burs );Dental Burs ( Diamond Burs Sets: Finishing and Polishing Set );Dental Burs ( Diamond Burs Sets: Preparation Set Plus+, Preparation Set, Cavity Set ); | 2015 |
| Endodontic Pulp Canal Filling Material SpreaderEKK · Class 1 | Dental hand instruments | Maker | Endodontic Stainless Steel Spreaders / Pluggers | 2015 |
| Gutta-PerchaEKM · Class 1 | Root canal filling materials | Maker | Gutta Percha Point | 2024 |
| Endodontic Paper PointEKN · Class 1 | Root canal filling materials | Maker | Absorbent Paper Points | 2024 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | Endodontic Files NiTi ( K-Files / H-Files / Reamers / C-Files / CRC Plus Files / C+ Files / U Files );Endodontic Files Stainless Steel ( K-Files / H-Files / Reamers / C-Files / CRC Plus Files / C+ Files / U Files );Endodontic Tapered NiTi Rotary Files ( Pliancy Blue Files, Pliancy Gold Files / RTM Files );Endodontic Tapered NiTi Rotary Files ( Pliancy Total Solution Files / G-Tiny Glide Path Files );Endodontic Tapered NiTi Rotary Files ( Pliancy W-1 Files, W-1 Files );Endodontic Tapered NiTi Rotary Files ( Tapered NiTi Rotary Files, Taper NiTi Hand Use Files );Endodontic Tapered NiTi Rotary Files ( X-20 Files/ Pliancy X-20 Plus Files / Pliancy X-20 Files );Paste Carriers / Lentulo / Filler. | 2015 |
| Endodontic BroachEKW · Class 1 | Endodontic files | Maker | Endodontic Barbed Broaches | 2015 |
| Root Canal PostELR · Class 1 | Root canal filling materials | Maker | Dental Root Canal Post; Screw Post / Quartz Fiber Post | 2015 |
| General Purpose Dental TrayOFX · Class 1 | — | Maker | Air Water Syringe Handpiece Unit / High Speed Dental Handpiece / Low Speed Dental Handpiece /Dental Contra Angle Handpiece / Dental Straight Handpiece | 2015 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Henan Lusterdent Medical Instrument Co.,LtdFDA reg. 3011713204 | Zhengzhou Henan, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10049376). 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.