Manufacturer registered with FDA
Henan Baistra Medical Devices Limited
Zhengzhou, China. Lists 25 dental device types with FDA across 1 registered establishment.
- Device types listed
- 25
- Brands and models
- 25
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1China
Devices listed with FDA
What Henan Baistra Medical Devices Limited currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Saliva Ejector MouthpieceDYN · Class 1 | — | Maker | Mouthpiece, saliva ejector | 2025 |
| Orthodontic TubeDZD · Class 1 | Orthodontic wires & bands | Maker | TUBE, ORTHODONTIC | 2022 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | INSTRUMENTS, DENTAL HAND | 2025 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | MIRROR, MOUTH | 2026 |
| Dental Operating LightEAZ · Class 1 | Dental operating lights | Maker | Dental Operating Light | 2025 |
| Orthodontic Elastic BandECI · Class 1 | Orthodontic wires & bands | Maker | BAND, ELASTIC, ORTHODONTIC | 2022 |
| Orthodontic Wire ClampECN · Class 1 | — | Maker | CLAMP, WIRE, ORTHODONTIC | 2022 |
| Articulation PaperEFH · Class 1 | — | Maker | PAPER, ARTICULATION | 2026 |
| Intraoral Dental WaxEGD · Class 1 | — | Maker | WAX, DENTAL, INTRAORAL | 2026 |
| Abrasive PointEHL · Class 1 | Polishing & prophylaxis | Maker | POINT, ABRASIVE | 2025 |
| Polishing Agent StripEHM · Class 1 | Polishing & prophylaxis | Maker | Polishing Strip | 2025 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | TRAY, IMPRESSION, PREFORMED | 2025 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Maker | SYRINGE, RESTORATIVE AND IMPRESSION MATERIA | 2025 |
| Dental Retractor AccessoriesEIF · Class 1 | Dental hand instruments | Maker | ACCESSORIES, RETRACTOR, DENTAL | 2022 |
| Dental Plastic Filling InstrumentEIY · Class 1 | Dental hand instruments | Maker | INSTRUMENT, FILLING, PLASTIC, DENTAL | 2022 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Maker | BRACKET, METAL, ORTHODONTIC | 2022 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | BUR, DENTAL | 2022 |
| Polishing Agent WheelEJQ · Class 1 | Polishing & prophylaxis | Maker | WHEEL, POLISHING AGENT | 2025 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Maker | AGENT, POLISHING, ABRASIVE, ORAL CAVITY | 2026 |
| Gutta-PerchaEKM · Class 1 | Root canal filling materials | Maker | GUTTA-PERCHA | 2022 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | FILE, PULP CANAL, ENDODONTIC | 2022 |
| Disposable Fluoride TrayKMT · Class 1 | — | Maker | TRAY, FLUORIDE, DISPOSABLE | 2025 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Dental Implant Torque Wrench | 2025 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Maker | Unit, operative dental, accessories | 2025 |
| Patient Personal Hygiene KitNSB · Class 1 | — | Maker | Patient personal hygiene kit | 2022 |
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 BAISTRA MEDICAL DEVICES LIMITEDFDA reg. 3023443842 | Zhengzhou Henan, China | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10085746). 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.