FDA.reportPublic FDA data

House Brand Dentistry

Primary DI
G001HSB1072002
Brand
House Brand Dentistry
Company
Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd.
Model
HSB-107200
Published
2024-06-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
G001HSB1072001PrimaryHIBCC0
G001HSB1072002Unit of UseHIBCC0

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
529534554
Device count
32
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G001RG31RGRG32025-06-27
G001RG30RGRG32025-04-30
G001HSB1071100House BrandHSB-1071102024-09-06
G001HSB107114House BrandHSB-1071142024-09-06
G001HSB1071150House BrandHSB-1071152024-09-06
G001HSB1071190House BrandHSB-1071192024-09-06
G001HSB1072000House BrandHSB-1072002024-09-06
G001HSB1071101House Brand DentistryHSB-1071102024-06-05
G001HSB1071140House Brand DentistryHSB-1071142024-06-05
G001HSB1071151House Brand DentistryHSB-1071152024-06-05
G001HSB1071191House Brand DentistryHSB-1071192024-06-05
G001HSB1072001House Brand DentistryHSB-1072002024-06-05
G001HSB1071102House Brand DentistryHSB-1071102024-06-05
G001HSB1071141House Brand DentistryHSB-1071142024-06-05
G001HSB1071152House Brand DentistryHSB-1071152024-06-05
G001HSB1071192House Brand DentistryHSB-1071192024-06-05
G001N23100ShifengN-23102020-11-19
G001N25100ShifengN-25102020-12-01
G001N25150ShifengN-25152020-12-01
G001S10000ShifengS-10002020-12-01

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
D974BSI10181BritedentBright Supply, Inc.EIB2024-04-08
D974BSI10180BritedentBright Supply, Inc.EIB2024-04-08
08964003163785Doctor NiceB. Ali ImpexEIB2024-01-29
08964003163433NivoB. Ali ImpexEIB2024-01-27
G002HSB107110House brand SHIFENG MEDICAL TECHNOLOGY CO.，LTD.EIB2023-05-10
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