FDA Registration
Active
🇨🇳 China
XIANTAO S&J PROTECTIVE PRODUCTS CO., LTD
Reg #: 3011434305
·
FEI: 3011434305
·
Expires 2026
Products
41
Proprietary Names
44
Establishment Types
2
Classifications
41
Registration Details
- Registration Name
- XIANTAO S&J PROTECTIVE PRODUCTS CO., LTD
- Registration Number
- 3011434305
- FEI Number
- 3011434305
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 18 Zhijin Road, Pengchang
- City
- Xiantao Hubei
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K211462
Owner / Operator
- Firm Name
- Xiantao S&J Protective Products Co., Ltd
- Operator Number
- 10058294
- Address
- 18 Zhijin Road, Pengchang
- City
- Xiantao
- State
- Hubei
- Postal Code
- 433000
- Country
- CN
- Correspondent
- Ge Wei
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 |
|---|---|---|---|---|---|
| Unit, Operative Dental, Accessories | NRD | Class 1 | Dental | No | 2021-11-16 |
| Chair, Dental, Without Operative Unit | NRU | Class 1 | Dental | No | 2021-11-16 |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | QKR | Class N | Unknown | No | 2020-05-01 |
| Mouthpiece, Saliva Ejector | DYN | Class 1 | Dental | No | 2022-11-06 |
| Disinfectant, Medical Devices | LRJ | Class 1 | General Hospital | No | 2023-07-31 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2021-11-16 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2022-11-06 |
| Basin, Emesis | FNY | Class 1 | General Hospital | No | 2023-08-23 |
| Dressing, Compression | MHW | Class 1 | General Hospital | No | 2022-11-07 |
| Depressor, Tongue, Non-Surgical | FMA | Class 1 | General Hospital | No | 2021-11-16 |
| Gown, Examination | FME | Class 1 | General Hospital | No | 2018-11-26 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2025-08-07 |
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2021-08-20 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2018-11-26 |
| Mirror, Mouth | EAX | Class 1 | Dental | No | 2022-11-06 |
| Accessories, Retractor, Dental | EIF | Class 1 | Dental | No | 2022-11-07 |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | Class 1 | General Hospital | No | 2021-11-16 |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | Class 1 | General, Plastic Surgery | No | 2021-11-16 |
| Apron, Protective | IWO | Class 1 | Radiology | No | 2022-09-29 |
| Gutta-Percha | EKM | Class 1 | Dental | No | 2024-09-12 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2023-04-27 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2021-11-16 |
| Unit, Syringe, Air And/Or Water | ECB | Class 1 | Dental | No | 2022-11-06 |
| Needle, Dental | DZM | Class 1 | Dental | No | 2024-09-12 |
| Evacuator, Oral Cavity | EHZ | Class 1 | Dental | No | 2021-11-16 |
| Point, Paper, Endodontic | EKN | Class 1 | Dental | No | 2024-09-12 |
| Applicator, Resin | KXR | Class 1 | Dental | No | 2021-11-16 |
| Cup, Prophylaxis | EHK | Class 1 | Dental | No | 2022-11-06 |
| Mask, Scavenging | KHA | Class 1 | Anesthesiology | No | 2019-04-29 |
| Cover, Shoe, Operating-Room | FXP | Class 1 | General, Plastic Surgery | No | 2019-04-29 |
| Syringe, Restorative And Impression Material | EID | Class 1 | Dental | No | 2025-02-21 |
| Toothbrush, Manual | EFW | Class 1 | Dental | No | 2021-11-16 |
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 2021-11-16 |
| Syringe, Periodontic, Endodontic, Irrigating | EIC | Class 1 | Dental | No | 2024-09-12 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2021-11-16 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2021-11-16 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2021-11-16 |
| Absorber, Saliva, Paper | KHR | Class 1 | Dental | No | 2021-11-16 |
| Cotton, Roll | EFN | Class 1 | Dental | No | 2021-11-16 |
| Suit, Surgical | FXO | Class 1 | General, Plastic Surgery | No | 2021-03-18 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2019-04-29 |
Proprietary Names
Tray cover; Air/water syringe sleeve; Barrier film; Bendable applicator brush; Bib holder; Clear curing light cover;
T-bar light handle cover; X-ray head sleeve
Digital sensor cover; Half chair sleeve; Handpiece sleeve; Headrest cover; Indicator strips; Indicator tape
Intraoral camera sleeve; Micro Brush Applicators; Paper wrapper; Paper/poly pouches; Plastic Prophy; Barrier envelopes
Barrier Sleeves
Disposable Face Mask, KN95 Protective Face Mask, KF94 Protective Face Mask
Mouthpiece, Saliva Ejector
Alcohol Pad, Hand Sanitizer, Medical Alcohol, Medical Devices Sanitizer Spray, Antiseptic Towelette
Surgical Drape, Keyboard Cover
Face Shields; Goggles; Safety Goggles; Spectacles
Emesis Bag; Emesis Bag Dispenser
Elastic Bandage; Gauze Bandage
DEPRESSOR, TONGUE, NON-SURGICAL
Lab Coats, Lab Jackets, Patient Gown, Scrub Suit, Visitor Gown, Disposable Shorts
Disposable Dental Kits, Oral Care Kits, Personal Hygiene Kits
Surgical Face Mask, Medical Face Mask
Gloves, Oversleeves, PE Oversleeves, Bouffant Cap, Clip Cap/Mob Cap, Surgeon Cap/Doctor Cap
Photographic Mirror; Mouth Mirror
Dental Retractor
Cotton Tip Applicators
Gauze sponge, X-ray detectable sponge, Cotton filled sponges
Disposable Apron, Non-woven Apron, PE Apron, CPE Apron
Gutta Percha Points
Denture Box; Retainer Box; Measure Cups
Adhesive bandage
Air/Water Syringe Tips, Curved Utility Syringes
Dental Needle
Oral Vented Evacuation Tips
Absorbent Paper Points
Micro Applicators
Prophy Cup; Prophy Brush; Prophy Angles, Dappen Dishes
Face Mask, Disposable Face Mask, Pleated Mask
Shoe Cover
HP Mixing Tips, Intra Oral Tips, Dispensing Guns
Toothbrush, Manual
Impression Trays - Dental, Bite Registration Trays, Fluoride Trays
Pre Bent Needles, Flow Tips, Irrigation Syringes with Curved Tip
Nonwoven Sponge, Nonwoven Gauze, Nonwoven Roll, Gelatin Hemostatic Sponge
Plastic Instrument Tray, Plastic Dental Tray
Isolation Gown, Non-Surgical Isolation Gown, CPE Gown
Patient Bibs, Crepe Paper, CSR Wrap
Cotton Roll
Surgical Gown, Coverall
Bedsheet, Bed Sheet Roll, Bedcover, Pillowcase, Body Bag, Underpad, Crepe Paper Roll, Drape Sheet, Table Cover
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device