FDA.reportPublic FDA data

Britedent

Primary DI
D974BSI10190
Brand
Britedent
Company
Bright Supply, Inc.
Model
BSI-1019
Device description
Prebent Dispensing Tips 19G Yellow
Published
2024-06-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
false
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
D974BSI10191PrimaryHIBCC0
D974BSI10190Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental material injection cannula, single-useA rigid or semi-rigid luminal device (dental tip) intended to channel and dispense a dental material/solution [e.g., restorative amalgam, resin, etching solution (etchant), topical dental anaesthetic] from a dental syringe, or similar applicator, to a patient’s teeth, oral mucosa, or gums; it is not intended to penetrate tissue (it is not a needle), not dedicated to root canal irrigation, and may be used for dental applications outside the patients mouth. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
124117012
Device count
100
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
false
Expiration date on label
false
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
D974BSI20031BritedentBSI-20032024-06-07
D974BSI55001BritedentBSI-55002025-08-21
D974BSI55002BritedentBSI-55002025-08-21
D974BSI29111BritedentBSI-29112025-03-11
D974BSI29112BritedentBSI-29112025-03-11
D974BSI01021BritedentBSI-01022020-11-26
D974BSI01031BritedentBSI-01032021-07-31
D974BSI01051BritedentBSI-01052021-08-12
D974BSI25031BritedentBSI-25032023-07-28
D974BSI25041BritedentBSI-25042024-01-18
D974BSI25051BritedentBSI-25052022-03-18
D974BSI25071BritedentBSI-25072021-12-31
D974BSI29011BritedentBSI-29012021-03-30
D974BSI29031BritedentBSI-29032021-04-22
D974BSI29051BritedentBSI-29052021-04-22
D974BSI29061BritedentBSI-29062021-04-22
D974BSI29091BritedentBSI-29092021-03-30
D974BSI29101BritedentBSI-29102021-06-28
D974BSI29121BritedentBSI-29122021-04-22
D974BSI29131BritedentBSI-29132021-06-28

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
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
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