FDA.reportPublic FDA data

DTK adhesive opak

Primary DI
EBRE540012959
Brand
DTK adhesive opak
Company
bredent GmbH & Co. KG
Model
54001295
Catalog number
54001295
Device description
DTK adhesive opak refill pack in a double mixing cartridge 1 x 8 g
Published
2023-09-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
EGGATTACHMENT, PRECISION, ALL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EGGAttachment, Precision, AllDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EBRE540012959PackageHIBCC1Not in Commercial Distribution
EBRE540012950PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental prosthesis priming agentA material primarily intended to be applied to a dental prosthesis (i.e., indirect restorative) and/or prosthesis component to promote bonding (e.g., to a composite resin cement, composite-based stain, or another prosthesis component). It may be referred to as a primer and includes compounds such as an unfilled-resin or silane-based agent; an applicator may also be included. The material is not intended to be used as a dentine bonding or dentine priming agent. After application, this device cannot be reused.

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
08800076418523T-L Cap SetTruabutment Korea Co.,LtdEGG2026-09-04
08059224151519OT EQUATORRHEIN 83 SRLEGG2026-08-27
08059224151526OT EQUATORRHEIN 83 SRLEGG2026-08-27
08059224160993OT EQUATORRHEIN 83 SRLEGG2026-08-27
08059224161006OT EQUATORRHEIN 83 SRLEGG2026-08-27
08059224161013OT EQUATORRHEIN 83 SRLEGG2026-08-27
08059224161037OT EQUATORRHEIN 83 SRLEGG2026-08-27
08059224161044OT EQUATORRHEIN 83 SRLEGG2026-08-27
08059224161051OT EQUATORRHEIN 83 SRLEGG2026-08-27
08059224197746OT EQUATORRHEIN 83 SRLEGG2026-08-27
08059224197753OT EQUATORRHEIN 83 SRLEGG2026-08-27
08059224197760OT EQUATORRHEIN 83 SRLEGG2026-08-27
08059224197777OT EQUATORRHEIN 83 SRLEGG2026-08-27
08059224197784OT EQUATORRHEIN 83 SRLEGG2026-08-27
08059224197791OT EQUATORRHEIN 83 SRLEGG2026-08-27
08059224218571PLUSRHEIN 83 SRLEGG2026-08-27
08059224218588PLUSRHEIN 83 SRLEGG2026-08-27
08059224218595PLUSRHEIN 83 SRLEGG2026-08-27
08059224218601PLUSRHEIN 83 SRLEGG2026-08-27
08059224218618PLUSRHEIN 83 SRLEGG2026-08-27
08059224218625PLUSRHEIN 83 SRLEGG2026-08-27
08059224218632PLUSRHEIN 83 SRLEGG2026-08-27
08059224218649PLUSRHEIN 83 SRLEGG2026-08-27
08059224218656PLUSRHEIN 83 SRLEGG2026-08-27
08059224218663PLUSRHEIN 83 SRLEGG2026-08-27
08059224218670PLUSRHEIN 83 SRLEGG2026-08-27
08059224218687PLUSRHEIN 83 SRLEGG2026-08-27
08059224218694PLUSRHEIN 83 SRLEGG2026-08-27
08059224127897OT EQUATORRHEIN 83 SRLEGG2026-06-23
08059224136097OT equatorRHEIN 83 SRLEGG2026-06-23