FDA.reportPublic FDA data

House Brand Dentistry

Primary DI
G001HSB1071101
Brand
House Brand Dentistry
Company
Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd.
Model
HSB-107110
Published
2024-06-05
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
DZMNeedle, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZMNeedle, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G001HSB1071101PrimaryHIBCC0
G001HSB1071102Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental syringe needle, single-useA sterile, sharp bevel-edged, hollow tubular metal instrument with an integral hub, typically intended to be attached to a dental cartridge syringe for the injection of local anaesthetics. This is a single-use device.

Regulatory Flags#

DUNS number
529534554
Device count
10
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
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
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
G001HSB1072002House Brand DentistryHSB-1072002024-06-05
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
D1250802Premium PlusPremium Plus (Dongguan) LimitedDZM2026-05-27
D1250812Premium PlusPremium Plus (Dongguan) LimitedDZM2026-05-27
D1250822Premium PlusPremium Plus (Dongguan) LimitedDZM2026-05-27
D125YS10012Premium PlusPremium Plus (Dongguan) LimitedDZM2026-05-27
D125YS10022Premium PlusPremium Plus (Dongguan) LimitedDZM2026-05-27
D125YS10072Premium PlusPremium Plus (Dongguan) LimitedDZM2026-05-27
D125YS10122Premium PlusPremium Plus (Dongguan) LimitedDZM2026-05-27
D832BLT1011PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT2001PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT2011PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT3001PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT3011PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT3021PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT4181PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT4201PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT4211PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT4221PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT4231PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT4251PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT4271PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT5221PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT522B1PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT5231PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT523B1PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT5251PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT525B1PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT6301PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT630M1PlasdentPLASDENT CORPORATIONDZM2026-05-01
20192253037422MonojectCardinal Health 200, LLCDZM2026-04-02
20192253037446MonojectCardinal Health 200, LLCDZM2026-04-02