Bifix Veneer LC

Primary DI
E22114241
Brand
Bifix Veneer LC
Company
VOCO GmbH
Model
1424
Catalog number
1424
Device description
Bifix Veneer LC is a light-curing, radiopaque nanohybrid luting composite for the adhesive luting oftranslucent veneers, inlays and onlays made of ceramic or composite, syringe 2g clear.
Published
2026-03-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EBFMaterial, Tooth Shade, Resin
EMACement, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2
EMACement, DentalDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252606000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252606000Bifix Veneer LC, Bifix Veneer Try-InVoco GmbH2026-03-20EMA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E22114241PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental composite resinA non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius28 Degrees Celsius

Regulatory Flags#

DUNS number
316699578
Device count
1
Lot or batch
true
Expiration date on label
true

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