FDA.report

Variolink Esthetic Try-In

Primary DI
07615208445787
Brand
Variolink Esthetic Try-In
Company
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Model
666067WW
Catalog number
666067WW
Device description
Variolink Esthetic Try. Ref.1.7g light+
Published
2023-04-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
EBFMaterial, tooth shade, resin

Product Code Classifications

CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07615208445787PackageGS110In Commercial Distribution
DVIV666067WW1PreviousHIBCC0
07615208295948PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07615208445787076152084457877615208445787
07615208295948076152082959487615208295948

GMDN Terms

TermDefinition
Dental cement trialA non-sterile substance intended to be used as a guide for selecting a good aesthetic match to the final dental cement to be used in a dental restoration of appliance procedure. It is typically supplied as a water-soluble paste consisting of glycerin, mineral fillers and pigments that does not cure and is intended to be washed off from the restoration and preparation surface prior to final cementation. After application, this device cannot be reused.

Sterilization Methods

Method

Regulatory Flags

DUNS number
448015938
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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07615208445947OptraSculpt639792AN639792AN2026-01-15
07615208590296Tetric CAD6921946921942026-01-13
07615208590258Tetric CAD6921936921932026-01-13
07615208590265Tetric CAD6921926921922026-01-13

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