FDA.reportPublic FDA data

Opaquer combo.lign GUM

Primary DI
EBRECO1X4OPG9
Brand
Opaquer combo.lign GUM
Company
bredent GmbH & Co. KG
Model
CO1X4OPG
Catalog number
CO1X4OPG
Device description
Opaquer combo.lign GUM dual-hardening composite 4 g syringe
Published
2016-09-20
Public version status
Update
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
EBFMATERIAL, TOOTH SHADE, RESIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EBRECO1X4OPG9PackageHIBCC1Not in Commercial Distribution
EBRECO1X4OPG0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental veneer, custom-madeA custom-made facial restoration of ceramic or polymer-based material (resin) used in aesthetic dentistry to correct the facial surface of a tooth. This is a single-use device.

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
false
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
EBREVLCOLBLACK9visio.lign color BlackVLCOLBLACKVLCOLBLACK2025-03-10
EBREVLCOLBLUE9visio.lign color BlueVLCOLBLUEVLCOLBLUE2025-03-10
EBREVLCOLBODYA9visio.lign color Body AVLCOLBODYAVLCOLBODYA2025-03-10
EBREVLCOLBODYB9visio.lign color Body BVLCOLBODYBVLCOLBODYB2025-03-10
EBREVLCOLBODYC9visio.lign color Body CVLCOLBODYCVLCOLBODYC2025-03-10
EBREVLCOLBODYD9visio.lign color Body DVLCOLBODYDVLCOLBODYD2025-03-10
EBREVLCOLBROWN9visio.lign color BrownVLCOLBROWNVLCOLBROWN2025-03-10
EBREVLCOLCREME9visio.lign color CremeVLCOLCREMEVLCOLCREME2025-03-10
EBREVLCOLGLIGHT9visio.lign color Gum LightVLCOLGLIGHTVLCOLGLIGHT2025-03-10
EBREVLCOLGPINK9visio.lign color Gum PinkVLCOLGPINKVLCOLGPINK2025-03-10
EBREVLCOLGRED9visio.lign color Gum RedVLCOLGREDVLCOLGRED2025-03-10
EBREVLCOLGREYBL9visio.lign color Grey-BlueVLCOLGREYBLVLCOLGREYBL2025-03-10
EBREVLCOLOLIVE9visio.lign color OliveVLCOLOLIVEVLCOLOLIVE2025-03-10
EBREVLCOLORANGE9visio.lign color OrangeVLCOLORANGEVLCOLORANGE2025-03-10
EBREVLCOLROSE9visio.lign color RoseVLCOLROSEVLCOLROSE2025-03-10
EBREVLCOLSET9visio.lign color SetVLCOLSETVLCOLSET2025-03-10
EBREVLCOLSKIT9visio.lign color Starter KitVLCOLSKITVLCOLSKIT2025-03-10
EBREVLCOLWHITE9visio.lign color WhiteVLCOLWHITEVLCOLWHITE2025-03-10
EBREVLCOLYELLOW9visio.lign color YellowVLCOLYELLOWVLCOLYELLOW2025-03-10
EBREVLSHIELDHV59visio.lign shield HVVLSHIELDHV5VLSHIELDHV52025-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00815967025856RodinPac-Dent, Inc.EBF2026-03-24
00815967025863RodinPac-Dent, Inc.EBF2026-03-24
00815967025870RodinPac-Dent, Inc.EBF2026-03-24
00815967021438OptiCompPac-Dent, Inc.EBF2026-03-23
00815967021797OptiCompPac-Dent, Inc.EBF2026-03-23
00815967027447RodinPac-Dent, Inc.EBF2026-03-23
00815967028161RodinPac-Dent, Inc.EBF2026-03-23
00815967028178RodinPac-Dent, Inc.EBF2026-03-23
00815967028185RodinPac-Dent, Inc.EBF2026-03-23
00815967028192RodinPac-Dent, Inc.EBF2026-03-23
00815967028208RodinPac-Dent, Inc.EBF2026-03-23
00815967028215RodinPac-Dent, Inc.EBF2026-03-23
00815967028222RodinPac-Dent, Inc.EBF2026-03-23
00815967028239RodinPac-Dent, Inc.EBF2026-03-23
00815967028246RodinPac-Dent, Inc.EBF2026-03-23
00815967028253RodinPac-Dent, Inc.EBF2026-03-23
00815967028260RodinPac-Dent, Inc.EBF2026-03-23
00815967028277RodinPac-Dent, Inc.EBF2026-03-23
00815967028284RodinPac-Dent, Inc.EBF2026-03-23
00815967028291RodinPac-Dent, Inc.EBF2026-03-23
00815967028307RodinPac-Dent, Inc.EBF2026-03-23
00815967028314RodinPac-Dent, Inc.EBF2026-03-23
00815967028321RodinPac-Dent, Inc.EBF2026-03-23
00815967028338RodinPac-Dent, Inc.EBF2026-03-23
00815967028345RodinPac-Dent, Inc.EBF2026-03-23
00815967028352RodinPac-Dent, Inc.EBF2026-03-23
00815967028369RodinPac-Dent, Inc.EBF2026-03-23
00815967028376RodinPac-Dent, Inc.EBF2026-03-23
00815967028383RodinPac-Dent, Inc.EBF2026-03-23
00815967028390RodinPac-Dent, Inc.EBF2026-03-23