FDA.reportPublic FDA data

Qu-connector

Primary DI
EBRE540011630
Brand
Qu-connector
Company
bredent GmbH & Co. KG
Model
54001163
Catalog number
54001163
Device description
Qu-connector Bonding agent for Qu-resin 10 ml
Published
2023-09-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KOLADHESIVE, DENTURE, CARBOXYMETHYLCELLULOSE SODIUM (32%) AND ETHYLENE-OXIDE HOMOPOLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KOLAdhesive, Denture, Carboxymethylcellulose Sodium (32%) And Ethylene-Oxide HomopolymerDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EBRE540011639PackageHIBCC1Not in Commercial Distribution
EBRE540011630PrimaryHIBCC0

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

Contacts#

Phone, Email table
PhoneEmail
+4907309872531regulatory-affairs@bredent.com
+4907309872451info@bredent.com

Regulatory Flags#

DUNS number
341086190
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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
EBRE540011639Qu-connectorbredent GmbH & Co. KGKOL2023-09-07
00814832010300EFFERGRIP ADHESIVE 1.5OZ TUBE 24Medtech Products Inc.KOL2022-10-07
00814832010317EFFERGRIP ADHESIVE 2.5OZ TUBE 12Medtech Products Inc.KOL2022-10-07
10814832010307EFFERGRIP ADHESIVE 1.5OZ TUBE 24MEDTECH PRODUCTS INC.KOL2022-10-07
10814832010314EFFERGRIP ADHESIVE 2.5OZ TUBE 12MEDTECH PRODUCTS INC.KOL2022-10-07
EBRE540011850DTK adhesive assortmentbredent GmbH & Co. KGKOL2016-09-27
EBRE540011859DTK adhesive assortmentbredent GmbH & Co. KGKOL2016-09-27
EBRE540011950DTK adhesive refill packbredent GmbH & Co. KGKOL2016-09-22
EBRE540011959DTK adhesive refill packbredent GmbH & Co. KGKOL2016-09-22