FDA.reportPublic FDA data

Qu-resin dentine color

Primary DI
EBRE540011629
Brand
Qu-resin dentine color
Company
bredent GmbH & Co. KG
Model
54001162
Catalog number
54001162
Device description
Qu-resin dentine color 1 Assortment
Published
2023-09-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
EKODenture preformed (partially prefabricated denture)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKODenture Preformed (Partially Prefabricated Denture)Dental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EBRE540011629PackageHIBCC1Not in Commercial Distribution
EBRE540011620PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental composite resinA non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00keep out of sunlight

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4907309872451info@bredent.com

Regulatory Flags#

DUNS number
341086190
Device count
1
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
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
EBRE540033990breCAM.HIPC540033992026-05-07
EBRE540034010breCAM.HIPC540034012026-05-07
EBRE540034060breCAM.HIPC540034062026-05-07
EBRE540021110breCAM.BioHPP54002111540021112016-09-20
EBRE540021210breCAM.BioHPP54002121540021212016-09-20
EBRE580012660Qu-resin dentin58001266580012662023-09-07
EBREVLCOLBLACK0visio.lign color BlackVLCOLBLACKVLCOLBLACK2025-03-10
EBREVLCOLBLUE0visio.lign color BlueVLCOLBLUEVLCOLBLUE2025-03-10
EBREVLCOLBODYA0visio.lign color Body AVLCOLBODYAVLCOLBODYA2025-03-10
EBREVLCOLBODYB0visio.lign color Body BVLCOLBODYBVLCOLBODYB2025-03-10
EBREVLCOLBODYC0visio.lign color Body CVLCOLBODYCVLCOLBODYC2025-03-10
EBREVLCOLBODYD0visio.lign color Body DVLCOLBODYDVLCOLBODYD2025-03-10
EBREVLCOLBROWN0visio.lign color BrownVLCOLBROWNVLCOLBROWN2025-03-10
EBREVLCOLCREME0visio.lign color CremeVLCOLCREMEVLCOLCREME2025-03-10
EBREVLCOLGLIGHT0visio.lign color Gum LightVLCOLGLIGHTVLCOLGLIGHT2025-03-10
EBREVLCOLGPINK0visio.lign color Gum PinkVLCOLGPINKVLCOLGPINK2025-03-10
EBREVLCOLGRED0visio.lign color Gum RedVLCOLGREDVLCOLGRED2025-03-10
EBREVLCOLGREYBL0visio.lign color Grey-BlueVLCOLGREYBLVLCOLGREYBL2025-03-10
EBREVLCOLOLIVE0visio.lign color OliveVLCOLOLIVEVLCOLOLIVE2025-03-10
EBREVLCOLORANGE0visio.lign color OrangeVLCOLORANGEVLCOLORANGE2025-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D7091032138Baltic Denture System BDCreatorMerz Dental GmbHEKO2017-11-25
D7091032228Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03
D7091032229Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03
D7091032230Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03
D7091032231Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03
D7091032232Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03
D7091032233Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03
D7091032234Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03
D7091032235Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03
D7091032236Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03
D7091032237Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03
D7091032238Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03
D7091032239Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03
D7091032240Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03
D7091032241Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03
D7091032242Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03
D7091032243Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03
D7091032244Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03
D7091032245Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03
D7091032246Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03
D7091032247Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03
D7091032248Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03
D7091032249Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03
D7091032250Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03
D7091032251Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03
D7091032252Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03
D7091032253Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03
D7091032254Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03
D7091032255Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03
D7091032256Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03