FDA.reportPublic FDA data

DTK adhesive refill pack

Primary DI
EBRE540011950
Brand
DTK adhesive refill pack
Company
bredent GmbH & Co. KG
Model
54001195
Catalog number
54001195
Device description
DTK adhesive refill pack in a double mixing cartridge 1 x 8 g
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
EBRE540011959PackageHIBCC1Not in Commercial Distribution
EBRE540011950PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental repair kit, ceramicA packaged collection of devices used for the repair of fractured porcelain veneers. This kit is used by a dentist and may include etching gel or liquid, bonding material, silanization liquid, a polymer-based restorative material (composite) and several other devices. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+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
EBRE540011630Qu-connectorbredent GmbH & Co. KGKOL2023-09-07
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
EBRE540011959DTK adhesive refill packbredent GmbH & Co. KGKOL2016-09-22