FDA.reportPublic FDA data

Britedent

Primary DI
D974BSIDLB2
Brand
Britedent
Company
Bright Supply, Inc.
Model
BSI-DLB
Device description
Blue Denture Box (ladder type).
Published
2024-03-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
true
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
JERCleaner, Denture, Mechanical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JERCleaner, Denture, MechanicalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D974BSIDLB2PackageHIBCC20In Commercial Distribution
D974BSIDLB1PrimaryHIBCC0
D974BSIDLB0Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Denture cleaning containerA non-powered receptacle intended to be used to clean/rinse a denture or similar dental prosthesis (e.g., a bridge). It is in the form of a container intended to hold the denture, typically with a denture cleansing solution, which may be manually agitated. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
124117012
Device count
12
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
D974BSIDLB1BritedentBright Supply, Inc.JER2024-03-12
D974BSIDLW1BritedentBright Supply, Inc.JER2024-03-12
D974BSIRHB1BritedentBright Supply, Inc.JER2024-03-12
D974BSIRHW1BritedentBright Supply, Inc.JER2024-03-12
D974BSIDLW0BritedentBright Supply, Inc.JER2024-03-12
D974BSIRHB2BritedentBright Supply, Inc.JER2024-03-12
D974BSIRHW2BritedentBright Supply, Inc.JER2024-03-12
D974BSIDASST1BritedentBright Supply, Inc.JER2024-03-11
D974BSIRASST1BritedentBright Supply, Inc.JER2024-03-11
D974BSIDASST2BritedentBright Supply, Inc.JER2024-03-11
D974BSIRASST2BritedentBright Supply, Inc.JER2024-03-11
J009670010000SymproRenfert GmbHJER2023-07-10
D746RBUSC1Cordless Sonic CleanerDENTSPLY SIRONA ORTHODONTICS INC.JER2023-06-13
D746RBUSCC1Cordless Sonic CleanerDENTSPLY SIRONA ORTHODONTICS INC.JER2023-06-13
D687215051CleanletsSultan Healthcare IncJER2022-11-30
00814832011093EFFDNT DENT BATH KIT 1CTMedtech Products Inc.JER2022-09-30
00348783003826Pro CleanPREMIER DENTAL PRODUCTS COMPANYJER2022-06-29
00348783003833Pro CleanPREMIER DENTAL PRODUCTS COMPANYJER2022-06-29
00348783003840Pro CleanPREMIER DENTAL PRODUCTS COMPANYJER2022-06-29
D6919011102Pro CleanPREMIER DENTAL PRODUCTS COMPANYJER2022-06-29
D6919011103Pro CleanPREMIER DENTAL PRODUCTS COMPANYJER2022-06-29
D6919011992Pro CleanPREMIER DENTAL PRODUCTS COMPANYJER2022-06-29
D746RB368C1RETAINER BRITE®DENTSPLY SIRONA ORTHODONTICS INC.JER2021-05-01
H65890040891Henry ScheinHENRY SCHEIN, INC.JER2019-05-15