Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3043648115

FEI Number

3043648115

Entity Name

DEBO MEDICAL TECHNOLOGY (SHIJIAZHUANG) CO., LTD.

City/State/Country

Shijiazhuang Hebei, CN

Establishment Address

North side of the road, 200 meters west of the intersection of Jinken East Road and Xiaokang Road, Gaofeng Village, Donglizhuang Town, Jinzhou City, Shijiazhuang Hebei 052260, CN

Establishment Type(s)

Foreign Private Label Distributor,Repack or Relabel Medical Device,Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Debo Medical Technology (Shijiazhuang) Co., Ltd. (Owner Number: 10094976)

Owner / Operator Contact Address

North side of the road, 200 meters west of the intersection of Jinken East Road and Xiaokang Road, Gaofeng Village, Donglizhuang Town, Jinzhou City, Shijiazhuang, CN-HE 052260, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Dental Mouth Mirror Oral Observer (Intraoral Endoscope) Disposable Dental Instrument Kit MIRROR. MOUTH UNIT, SUCTION OPERATORY ECG cable Cheek Retractor/Mouth Opener/Lip Retractor Portable Oral Irrigator Rechangeable, Nasal Irrigator, Nasal Wash Bottle Dental Bite Guard Protector,Dental Supplies Face Shield Screw Post Surgical Denture Base Trimmer Tool Surgical Trimming Instrument Blade, Saw, General & Plastic Surgery, Surgical Device, Digital lmage Storage, Radiological dental paper root canal therapy-absorbent paper points dental marking pen BLADE,SCALPEL Blade sanitary finger rest / sterile finger rest finger rest Alanine Aminotransferase / Serum Glutamic-Pyruvic Transaminase Hydrazone colorimetric method agitator / stirrer mixer Magnifier, Hand-Held, Low-Vision dental magnifier EQUIPMENT. LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR ASPECIFIC MEDICAL USE Medical Caps/Disposable isolation cap/Disposable isolation hat, Head cover Surgical Cap Bouffant Cap Orthodontic Springs ligature tie gun Orthodontic accessories Endodontic Root Canal Plug Dental Bur MEDICAL EXAMINATION GLOVES sample container, non-sterile Dental Camera Disposable Cups, Universal Barrier Film, Universal Barrier Film Dispenser dental chair without operating unit Gutta Percha Points Surgical Mask Surgical Respirator Disposable medical mask Disposable Medical Mask Apparatus, Suction, Single Patient Use, Portable, Nonpowered UTENSIL, EATING Dental Plastic edge SHOE AND SHOE COVER Torque wrench silicone teether toy Baby Teether Silicone Teether Non-Fluid Filled Teether Denture Box / Denture Case Matrix Bands,Denture Box Retainer Box Cotton Rolls COTTON BALLS COTTON PADS High Volume HVE Tips evacuation tips Dental irrigation syringe 3-WAY AIR WATER SYRINGE TIP suction device oral cavity surgical tips 3-Way Air Water Syringe Tip air/ water tips high-volume evacuation (HVE) tip Cotton Roll Dispenser Barrier Film Dispenser Solid Medication Dispenser Ring, Teething, Fluid-Filled dental amalgam capsule dental band orthodontic elastic material elastic material orthodontic kit probe (forceps) orthodontic supplies dental model orthodontic bracket orthodontic buccal tube elastic chain separator elastomer Dental Polishing Brush orthodontic band ligature tie orthodontic archwire polishing brush rubber toothpick, Soft Pick Dental Floss Box, Dental Floss Holder, Dental Floss Pick Dental floss, Power Flosser, Interdental Brush, Dental Flosspick/Tooth Pick Floss MATERIAL, IMPRESSION TRAY, RESIN Dental Gum Dam Gingival Protection Gel Dental Dam Gum Protector Gel dental splints over-the-counter product denture pad cushion / liner wax-impregnated cotton cloth Mouthpiece, Saliva Ejector articulating paper PAPER, ARTICULATION Orthodontic pliers WAX, DENTAL,INTRAORAL Air-Water Syringe Tip Air/Water Syringe Unit Oral Cavity Suction Device Endoscopic Bite Block, Intra oral camera Dental needles Dispensing Tip Pre-Bent Needle Tip Dental Care Kit Tray, Fluoride, Disposable - Dental Disposable Fluoride Tray Orthodontic Arch Wire Dione Cold Light Tooth Whitening Instrument, Enamel Care/Colour Corrector/Hyaluronic Serum Teeth Whitening Pen, Teeth Whitening Toothpaste, teeth whitening machine, Whitening Materials Teeth Whitening Kit(Regular Strength Serum,Maximum Strength Serum,Desensitizing Serum,Teeth Whitening GEL Operative Amalgam Carrier NONWOVENS THE INJECTION OF SLILCON RUBBER Restorative and Impression Material Syringe Mixing Bowl and Spatula Disposable gauze Non-absorbent gauze/sponge Dental Tray Liner Alcohol Prep Pad Cotton Gauze Mixing Pad non-woven gauze Stirring Rod Non-absorbent Gauze/Sponge, for External Use Mixing Spatula Non-woven Gauze Dental Occlusion Paper INSTRUMENT, LIGATURE TUCKINGORTHODONTIC Apron/Raincoat paper apron Bibs Sleeve Cover/Disposable arm sleeve Beard cover paper bib Medical Drapes Treatment Towel plastic apron/Surgical Apron GLOVE/Washing Gloves dental bib Dental kit, Denture cleansing tablets, Tooth Cleanser, Denture, Denture Cleanser, Cleaning tablets, Mouthwash Tablets Dental sealing machine Dental blending paper General-Purpose Manual Surgical Instrument INSTRUMENT, MANUAL SURGICALGENERAL USE Cotton Roll Dispenser Dental Apron Dispenser Retractor, All Types -Cheek Retractor CONTAINER, LIQUID MEDICATIONGRADUATED Ultrasonic cleaning machine Cleaner, Ultrasonic, Medical Instrument Protective Shield Eyewear Safety Goggles Ophthalmic Supplies (including sunlamp protective glasses and post-mydriasis glasses) Ophthalmic Hospital Supplies Shield, Protective, Personnel Mouth Prop Accessories, Retractor, Dental-Mouth Prop POLISHING AGENT Alginate mixer Pill Crusher/Cutter -Pill Crusher/Cutter Separator Elastormeric elastic material Orthodontic Elastics ligature tie Orthodontic bands Arch Wire bandage orthodontic elastic rubber chain Elastane Chain orthodontic supplies Ligature Tie Tonque Depressor lectric nasal washer/nasal-irrigator Tofflemire Matrix Bands COVER, CAST PE Rain Coat, Scrub Suit,Cover Gown, Impervious Gown Patient Gown, CPE Gown, Disposable Lab Coat, Disposable Suits, Examination Gown Medical Disposable Protective Clothing,Doctor uniforms, Nurse uniforms Gown, Isolation clothing(Non-sterile)/Non-surgical Isolation Gown Dressing, Visitor Gown, Clothing, Coverall/Protection Suit/Protective coverall/Gown Mask, Scavenging denture cleaner ECG Conductive Gel chewable tablets metal orthodontic appliance metal braces orthodontics Orthodontic Metal Brackets, Ceramic Bracket, Self-Ligating Brackets, Metal V-slot Brackets, Orthodontic brackets orthodontic appliance orthodontic bracket metal orthodontic bracket ORTHODONTIC KIT APPLICATOR,ABSORBENT TIPPED, NON.STERILE Cotton Applicator Applicator, Absorbent Tpped,Non-sterile Applicator with Absorbent Tip Cotton Swab / Cotton Tip Applicator COTTON STICK Operating Room Operating Room Drapes Dust Cover Shoe Covers

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2026-01-12
EBR	Unit, Suction Operatory	Dental	Class 1	872.6640	2026-01-12
ISN	Cable	Physical Medicine	Class 1	890.3420	2026-01-12
KBN	Gag, Mouth	Ear, Nose, Throat	Class 1	874.4420	2026-01-12
KAR	Irrigator, Sinus	Ear, Nose, Throat	Class 1	874.4420	2026-01-12
BRW	Protector, Dental	Anesthesiology	Class 1	868.5820	2026-01-12
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2026-01-12
ELR	Post, Root Canal	Dental	Class 1	872.3810	2026-01-12
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	2026-01-12
LMB	Device, Digital Image Storage, Radiological	Radiology	Class 1	892.2010	2026-01-12
EKN	Point, Paper, Endodontic	Dental	Class 1	872.3830	2026-01-12
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2026-01-12
LZB	Finger Cot	General Hospital	Class 1	880.6250	2026-01-12
CKD	Hydrazone Colorimetry, Alt/Sgpt	Clinical Chemistry	Class 1	862.1030	2026-01-12
JRO	Blender/Mixer	Clinical Chemistry	Class 1	862.2050	2026-01-12
HJF	Magnifier, Hand-Held, Low-Vision	Ophthalmic	Class 1	886.5540	2026-01-12
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2026-01-12
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2026-01-12
ECO	Spring, Orthodontic	Dental	Class 1	872.5410	2026-01-12
DYJ	Retainer, Screw Expansion, Orthodontic	Dental	Class 1	872.5410	2026-01-12
EKK	Spreader, Pulp Canal Filling Material, Endodontic	Dental	Class 1	872.4565	2026-01-12
EJL	Bur, Dental	Dental	Class 1	872.3240	2026-01-12
IWP	Radiographic Protective Glove	Radiology	Class 1	892.6500	2026-01-12
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2026-01-12
NRD	Unit, Operative Dental, Accessories	Dental	Class 1	872.6640	2026-01-12
NRU	Chair, Dental, Without Operative Unit	Dental	Class 1	872.6250	2026-01-12
EKM	Gutta-Percha	Dental	Class 1	872.3850	2026-01-12
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2026-01-12
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2026-01-12
ILC	Utensil, Eating	Physical Medicine	Class 1	890.5050	2026-01-12
ELM	Denture, Plastic, Teeth	Dental	Class 2	872.3590	2026-01-12
BWP	Shoe And Shoe Cover, Conductive	General, Plastic Surgery	Class 1	878.4040	2026-01-12
HXC	Wrench	Orthopedic	Class 1	888.4540	2026-01-12
MEF	Ring, Teething, Non-Fluid Filled	Dental	Class 1	872.5550	2026-01-12
GCZ	Retainer, Surgical	General, Plastic Surgery	Class 1	878.4800	2026-01-12
EFN	Cotton, Roll	Dental	Class 1	872.6050	2026-01-12
EHZ	Evacuator, Oral Cavity	Dental	Class 1	872.6640	2026-01-12
NXB	Dispenser, Solid Medication	Physical Medicine	Class 1	890.5050	2026-01-12
KKO	Ring, Teething, Fluid-Filled	Dental	Class 2	872.5550	2026-01-12
DZS	Capsule, Dental, Amalgam	Dental	Class 1	872.3110	2026-01-12
ECM	Band, Preformed, Orthodontic	Dental	Class 1	872.5410	2026-01-12
JES	Floss, Dental	Dental	Class 1	872.6390	2026-01-12
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	2026-01-12
EIE	Dam, Rubber	Dental	Class 1	872.6300	2026-01-12
HSP	Splint, Traction	Orthopedic	Class 1	888.5890	2026-01-12
NKJ	Cushion, Pad, Denture, Wax Impregnated Cotton, Over The Counter	Dental	Class 1	872.3540	2026-01-12
DYN	Mouthpiece, Saliva Ejector	Dental	Class 1	872.6640	2026-01-12
EFH	Paper, Articulation	Dental	Class 1	872.6140	2026-01-12
JEX	Plier, Orthodontic	Dental	Class 1	872.4565	2026-01-12
EGD	Wax, Dental, Intraoral	Dental	Class 1	872.6890	2026-01-12
ECB	Unit, Syringe, Air And/Or Water	Dental	Class 1	872.4565	2026-01-12
MNK	Endoscopic Bite Block	Gastroenterology, Urology	Class 1	876.1500	2026-01-12
DZM	Needle, Dental	Dental	Class 1	872.4730	2026-01-12
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2026-01-12
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	2026-01-12
MAU	Eraser, Dental Stain	Dental	Class 1	872.6855	2026-01-12
EKI	Carrier, Amalgam, Operative	Dental	Class 1	872.4565	2026-01-12
MHW	Dressing, Compression	General Hospital	Class 1	880.5075	2026-01-12
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	2026-01-12
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2026-01-12
ECP	Instrument, Ligature Tucking, Orthodontic	Dental	Class 1	872.4565	2026-01-12
IWO	Apron, Protective	Radiology	Class 1	892.6500	2026-01-12
NSB	Patient Personal Hygiene Kit	Dental	Class 1	872.6855	2026-01-12
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2026-01-12
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2026-01-12
EIG	Retractor, All Types	Dental	Class 1	872.4565	2026-01-12
KYW	Container, Liquid Medication, Graduated	General Hospital	Class 1	880.6430	2026-01-12
FLG	Cleaner, Ultrasonic, Medical Instrument	General Hospital	Class 1	880.6150	2026-01-12
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2026-01-12
KPY	Shield, Protective, Personnel	Radiology	Class 1	892.6500	2026-01-12
EIF	Accessories, Retractor, Dental	Dental	Class 1	872.4565	2026-01-12
EJQ	Wheel, Polishing Agent	Dental	Class 1	872.6010	2026-01-12
JDZ	Mixer, Cement, For Clinical Use	Orthopedic	Class 1	888.4210	2026-01-12
OHY	Pill Crusher/Cutter	General Hospital	Class 1	880.6430	2026-01-12
ECI	Band, Elastic, Orthodontic	Dental	Class 1	872.5410	2026-01-12
FMA	Depressor, Tongue, Non-Surgical	General Hospital	Class 1	880.6230	2026-01-12
KMA	Irrigator, Powered Nasal	Ear, Nose, Throat	Class 1	874.5550	2026-01-12
EKF	Instrument, Contouring, Matrix, Operative	Dental	Class 1	872.4565	2026-01-12
KIA	Cover, Cast	General Hospital	Class 1	880.6185	2026-01-12
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2026-01-12
KHA	Mask, Scavenging	Anesthesiology	Class 1	868.5590	2026-01-12
JER	Cleaner, Denture, Mechanical	Dental	Class 1	872.3530	2026-01-12
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2026-01-12
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2026-01-12
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2026-01-12
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2026-01-12

Official Correspondent

Ting Li

US Agent Details

Creekon Yang Email: fda.agent@spicagloble.com Phone: (720) 6176666

Related Public Records

Same Entity

Debo Medical Technology (Shijiazhuang) Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K953012	Boston Surgical Products, Inc.	DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS	1995-07-12
K102092	Prestige Ameritech	PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES	2010-10-06
K883982	Iberhospitex, S.A.	DRENOVAC	1989-02-23
K070591	Union Dental S.A./Unidesa.Odi	REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETH	2007-05-11
K915276	Nobelpharma USA, Inc.	DENTURE PLASTIC TEETH,76 ELM	1992-02-03

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2008	Becton Dickinson & Company	1	Shelf Pack: Bard-Parker Rib-Back Carbon Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417
Z-0013-2008	Becton Dickinson & Company	1	Shelf Pack: Bard-Parker Rib-Back Stainless Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417
Z-0002-2008	Beckman Coulter Inc	1	FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013	Biomerieux Inc	1	PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.
Z-0020-04	Vital Concepts, Inc.	1	Huntington Instruments brand Irrigation Aspiration System with Single Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55040. Labeled as Manufactured for Huntington Instruments, Ogden Utah.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043648115. Last updated year: 2026. Please use registration number 3043648115 when referencing this establishment in official correspondence.