FDA Registration
Active
🇨🇳 China
HUANGHUA DK DENTAL CO., LTD
Reg #: 3013463240
·
FEI: 3013463240
·
Expires 2026
Products
37
Proprietary Names
41
Establishment Types
1
Classifications
37
Registration Details
- Registration Name
- HUANGHUA DK DENTAL CO., LTD
- Registration Number
- 3013463240
- FEI Number
- 3013463240
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- YangSanMu Industrial Park
- City
- HuangHua Hebei
- Country
- CN
Owner / Operator
- Firm Name
- HUANGHUA DK DENTAL CO., LTD
- Operator Number
- 10054767
- Address
- YangSanMu Industrial Park
- City
- HuangHua
- State
- Hebei
- Postal Code
- 061100
- Country
- CN
- Correspondent
- John Liu
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln.,
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Accessories, Retractor, Dental | EIF | Class 1 | Dental | No | 2017-04-24 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2017-04-24 |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | Class 1 | General Hospital | No | 2017-04-24 |
| Band, Elastic, Orthodontic | ECI | Class 1 | Dental | No | 2025-01-06 |
| Unit, Operative Dental, Accessories | NRD | Class 1 | Dental | No | 2017-04-24 |
| Tip, Rubber, Oral Hygiene | JEW | Class 1 | Dental | No | 2024-01-09 |
| Shield, Eye, Radiological | IWS | Class 1 | Radiology | No | 2017-04-24 |
| Applicator, Resin | KXR | Class 1 | Dental | No | 2025-01-06 |
| Needle, Dental | DZM | Class 1 | Dental | No | 2024-02-01 |
| Dispenser, Liquid Medication | KYX | Class 1 | General Hospital | No | 2017-04-24 |
| Wheel, Polishing Agent | EJQ | Class 1 | Dental | No | 2024-01-09 |
| Mouthpiece, Breathing | BYP | Class 1 | Anesthesiology | No | 2022-07-01 |
| Cotton, Roll | EFN | Class 1 | Dental | No | 2024-01-09 |
| Spatula, Surgical, General & Plastic Surgery | GAF | Class 1 | General, Plastic Surgery | No | 2017-04-24 |
| Aligner, Bracket, Orthodontic | ECQ | Class 1 | Dental | No | 2023-01-12 |
| Brush, Dermabrasion, Manual | GED | Class 1 | General, Plastic Surgery | No | 2017-04-24 |
| Syringe, Restorative And Impression Material | EID | Class 1 | Dental | No | 2024-02-01 |
| Adaptor, Hygiene | ILS | Class 1 | Physical Medicine | No | 2017-04-24 |
| Probe, Periodontic | EIX | Class 1 | Dental | No | 2017-04-24 |
| Unit, Syringe, Air And/Or Water | ECB | Class 1 | Dental | No | 2017-04-24 |
| Pusher, Band, Orthodontic | ECS | Class 1 | Dental | No | 2023-01-12 |
| Mirror, Mouth | EAX | Class 1 | Dental | No | 2017-04-24 |
| Instrument, Filling, Plastic, Dental | EIY | Class 1 | Dental | No | 2017-04-24 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2017-04-24 |
| Forceps, Tooth Extractor, Surgical | EMG | Class 1 | Dental | No | 2017-04-24 |
| Exerciser, Measuring | ISD | Class 2 | Physical Medicine | No | 2023-04-17 |
| Toothbrush, Manual | EFW | Class 1 | Dental | No | 2024-01-09 |
| Dental Implant Surgical Tray | OFY | Class 1 | Dental | No | 2023-01-12 |
| Shield, Protective, Personnel | KPY | Class 1 | Radiology | No | 2017-04-24 |
| Holder, Film, X-Ray | EGZ | Class 1 | Dental | No | 2017-04-24 |
| Forceps, Dressing, Dental | EFL | Class 1 | Dental | No | 2017-04-24 |
| Gauge, Depth, Instrument, Dental | EIL | Class 1 | Dental | No | 2017-04-24 |
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 2017-04-24 |
| Wax, Dental, Intraoral | EGD | Class 1 | Dental | No | 2024-01-09 |
| Absorber, Saliva, Paper | KHR | Class 1 | Dental | No | 2024-01-09 |
| Container, Liquid Medication, Graduated | KYW | Class 1 | General Hospital | No | 2017-04-24 |
| Mouthpiece, Saliva Ejector | DYN | Class 1 | Dental | No | 2017-04-24 |
Proprietary Names
Dental Retractor, Mouth Props
Acrylic Display Stand; Disposable Dental Instrument Kit.Medical instrument tray;Sterilising Trays
Bur Holder,Cotton Roll Dispenser,Holder Of Medicine Bottle
DENTURE TRANSPORTATION BOX,ENDO HOLDER; soak sterilize cup
Micro Applicator
Brace elastics
Universal Barrier Film
Dental tip
safety Glasses
Prebent Tips
Dental needle, Prevent tips
Composite Dispenser Gun,IMPRESSION DISPENSER GUN;Amalaged carrier
Polish wheel, strip, brush, cup, dish
anti snoring mouthpiece
Cotton roll
Spatula
Aligner removal tool
Brush Applicator
Dental tip, Mixing tips
Denture Box; Cotton Roll Box; Bur box; DENTURE TRANSPORTATION BOX
Probe
Air-Water Syringe Tip, Cover Of Air-Water Syringe Tip,Curved Utility Syringes, HP Mixing Tip
Aligner chewies
Mouth Mirrors
Dental sectional contoured matrices; Dental sectional contoured matrices kit
Mouth Props,ENDO MEASURE BLOCK,ENDO CLEAN BLOCK;ENDO Ring and Chshions
Poly Wedge;wooden wedge; Silicone Rubber Mixing Tips
Forcep
Lung exerciser
Toothbrush
Orthodontic kit
Protective Light Hand Shield; Medical Face Shield With Frame
disposable glasses; mask with face shield; disposable face shield; Safety Glasses
X-Ray Film Holder, X-Ray system, Ring; Arm, Holder
Bib Clip; Cotton Roll Clips
Endo Ruler; Microdont; ENDO MEASURE BLOCK; ENDO CLEAN BLOCK
Tray;Impression Tray; Impression Tray Base; Tray Base;Teeth-whiten tray
Dental Wax
Dental Paper; Dental bib
Mixing Bowl, Silicone Rubber Cup, Plastic Dappen Dish, Mortar And Pestle, Medicine Bottle, Glass Dappen Dish
Saliva Ejector,Surgical aspirator tip,vented oral Evacuation tip
Establishment Types
Manufacture Medical Device