FDA.reportPublic FDA data

DTK adhesive opak

Primary DI
EBRE540012859
Brand
DTK adhesive opak
Company
bredent GmbH & Co. KG
Model
54001285
Catalog number
54001285
Device description
DTK adhesive opak assortment in a double mixing cartridge 5 Parts
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
EBRE540012859PackageHIBCC1Not in Commercial Distribution
EBRE540012850PrimaryHIBCC0

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
+4907309872531regulatory-affairs@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
08059224127897OT EQUATORRHEIN 83 SRLEGG2026-06-23
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H0005TX40StecoTitanmagnetics®steco-System-Technik GmbH & Co KGEGG2026-05-08
ESTOI0107K5000StecoTitanmagnetics®steco-System-Technik GmbH & Co KGEGG2025-10-14
ESTOV0003X2600StecoTitanmagnetics®steco-System-Technik GmbH & Co KGEGG2025-10-08
ESTOI6501K3000StecoTitanmagnetics®steco-System-Technik GmbH & Co KGEGG2025-05-22
ESTOI6501K4500StecoTitanmagnetics®steco-System-Technik GmbH & Co KGEGG2025-05-22
00842092110577MaysPreat CorporationEGG2023-10-17
00842092110737SplintastikPreat CorporationEGG2023-10-17
18056039211336NOBIL METAL SPANOBIL METAL SPAEGG2023-10-05
18056039211503NOBIL METAL SPANOBIL METAL SPAEGG2023-10-05
18056039211510NOBIL METAL SPANOBIL METAL SPAEGG2023-10-05
18056039211527NOBIL METAL SPANOBIL METAL SPAEGG2023-10-05
07640166516125Mini-SG® / Mini-SG® F/R / M-SG® Star 1Cendres+Métaux SAEGG2023-09-05
07640173093121Mini-SG® / Mini-SG® F/R / M-SG® Star 1Cendres+Métaux SAEGG2023-09-05
07640173093145Mini-SG® / Mini-SG® F/R / M-SG® Star 1Cendres+Métaux SAEGG2023-09-05
07640173093268Mini-SG® / Mini-SG® F/R / M-SG® Star 1Cendres+Métaux SAEGG2023-09-05
ESTOH0004K20StecoTitanmagnetics®steco-System-Technik GmbH & Co KGEGG2023-07-24
ESTOH0004K30StecoTitanmagnetics®steco-System-Technik GmbH & Co KGEGG2023-07-24
ESTOH0004K40StecoTitanmagnetics®steco-System-Technik GmbH & Co KGEGG2023-07-24
ESTOH0004X20StecoTitanmagnetics®steco-System-Technik GmbH & Co KGEGG2023-07-24
ESTOH0004Z10StecoTitanmagnetics®steco-System-Technik GmbH & Co KGEGG2023-07-24
ESTOU0001Z315K0StecoTitanmagnetics®steco-System-Technik GmbH & Co KGEGG2023-07-24
ESTOV0001X2500StecoTitanmagnetics®steco-System-Technik GmbH & Co KGEGG2023-07-24
ESTOV0001Z3000StecoTitanmagnetics®steco-System-Technik GmbH & Co KGEGG2023-07-24
00842092109281Preci 52Preat CorporationEGG2023-07-06
00842092110669FR AttachmentsPreat CorporationEGG2023-07-05
00842092109328Preci 52Preat CorporationEGG2023-06-20
00842092110652Precision AttachmentsPreat CorporationEGG2023-05-19