FDA.reportPublic FDA data

House brand

Primary DI
G002HSB107110
Brand
House brand
Company
SHIFENG MEDICAL TECHNOLOGY CO.，LTD.
Model
HSB-107110
Published
2023-05-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
EIBSyringe, Irrigating (Dental)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIBSyringe, Irrigating (Dental)Dental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G002HSB107110PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental irrigation/aspiration syringeA hand-held manual dental device (a plunger-type syringe) designed to inject and/or aspirate a volume of solution into the working area in the oral cavity. It typically consists of a small syringe (e.g., 3 ml) and is used for washing and aspirating the pulp cavity and root canal to remove debris. It is hand-operated by the user who exerts a steady pressure on, e.g., thumb rings and/or swivel finger bars, which exerts pressure on the syringe plunger forcing the washing/rinsing fluids through an attached needle (e.g., a blunt or very fine needle) directly at the operative site. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
554525197
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G002100640EZ100642024-10-30
G002100620EZ100622024-10-28
G002HSB107119House Brand DentistryHSB-1071192023-09-25
G002RG30RG3RG32022-07-22
G002100630Shifeng100632022-04-29
HSB107200House brandHSB-1072002022-04-17
HSB107114House brandHSB-1071142022-04-09
G002100170Shifeng100172021-09-26
G002100350Shifeng100352021-09-26
G002100360Shifeng100362021-09-26
G00210112251B0Shifeng1011-2251B2021-05-05
G002UU1L0UUUU1L2021-05-05
UUSF2251SN0ShifengUUSF2251SN2021-03-06
UUSF1LHN25100ShifengUUSF1LHN25102021-03-06
UUSF2231SN0ShifengUUSF2231SN2021-03-06
G002FUSF2510SN0FUTURE GENERATION MEDICALFUSF2510SN2021-02-27
G002UUSF1LHN23100ShifengUUSF1LHN23102021-02-27
G002UUSF2310SN0ShifengUUSF2310SN2021-02-27
G002UUSF1LL0ShifengUUSF1LL2021-02-14
G002UUSF2510SN0ShifengUUSF2510SN2021-02-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20192253068877MonojectCardinal Health 200, LLCEIB2026-01-29
50192253068878MonojectCardinal Health 200, LLCEIB2026-01-29
G001HSB107114House BrandChengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd.EIB2024-09-06
G001HSB1071150House BrandChengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd.EIB2024-09-06
G001HSB1071190House BrandChengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd.EIB2024-09-06
G001HSB1072000House BrandChengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd.EIB2024-09-06
00840183524234BR Surgical, LLCBR Surgical, LLCEIB2024-06-10
D974BSI10191BritedentBright Supply, Inc.EIB2024-06-07
D974BSI10211BritedentBright Supply, Inc.EIB2024-06-07
D974BSI10251BritedentBright Supply, Inc.EIB2024-06-07
D974BSI10190BritedentBright Supply, Inc.EIB2024-06-07
D974BSI10210BritedentBright Supply, Inc.EIB2024-06-07
D974BSI10250BritedentBright Supply, Inc.EIB2024-06-07
G001HSB1071140House Brand DentistryChengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd.EIB2024-06-05
G001HSB1071151House Brand DentistryChengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd.EIB2024-06-05
G001HSB1072001House Brand DentistryChengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd.EIB2024-06-05
G001HSB1071141House Brand DentistryChengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd.EIB2024-06-05
G001HSB1071152House Brand DentistryChengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd.EIB2024-06-05
G001HSB1072002House Brand DentistryChengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd.EIB2024-06-05
D974BSI10181BritedentBright Supply, Inc.EIB2024-04-08
D974BSI10180BritedentBright Supply, Inc.EIB2024-04-08
08964003163785Doctor NiceB. Ali ImpexEIB2024-01-29
08964003163433NivoB. Ali ImpexEIB2024-01-27
10850002458166Advance Dental ProductsThe Atlanta Dental Supply CompanyEIB2023-02-10
20850002458163Advance Dental ProductsThe Atlanta Dental Supply CompanyEIB2023-02-10
10665973030491UnipackUNIPACK MEDICAL CORPORATIONEIB2022-12-06
10665973030507UnipackUNIPACK MEDICAL CORPORATIONEIB2022-12-06
10665973030514UnipackUNIPACK MEDICAL CORPORATIONEIB2022-12-06
D784URN55003231UnipackUNIPACK MEDICAL CORPORATIONEIB2022-12-06
D784URN55003271UnipackUNIPACK MEDICAL CORPORATIONEIB2022-12-06