FDA.reportPublic FDA data

visio.lign shield HV

Primary DI
EBREVLSHIELDHV59
Brand
visio.lign shield HV
Company
bredent GmbH & Co. KG
Model
VLSHIELDHV5
Catalog number
VLSHIELDHV5
Device description
visio.lign shield HV 5 ml
Published
2025-03-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBDCoating, filling material, resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBDCoating, Filling Material, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240735000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240735000visio.lign color, visio.lign shieldBredent GmbH & Co. KG2024-12-12EBD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EBREVLSHIELDHV59PackageHIBCC1Not in Commercial Distribution
EBREVLSHIELDHV50PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental prosthesis veneer resinA dental resin composite material intended to be used for veneering a restorative dental prosthesis (e.g., crown, bridge, fixed or removable denture); some types may be used as stains to apply colour to the dental appliance. After application, this material cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00keep out of sunlight

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
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
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
08809896990288ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-15
08809896991056ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-15
08809896991063ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-15
00810184450030RodinPac-Dent, Inc.EBD2026-05-15
08809896990172ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990189ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990196ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990202ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990219ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990226ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990233ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990240ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990257ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990264ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990271ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990295ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990387ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990400ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990417ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990424ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990431ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990448ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990455ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990462ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990479ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990486ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990493ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990509ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990516ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990523ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14