FDA.reportPublic FDA data

Injectafil A2 Syringe with Extrusion Handle

Primary DI
00850194007367
Brand
Injectafil A2 Syringe with Extrusion Handle
Company
Vista Dental
Model
1
Catalog number
106-A2-Kit
Device description
Injectafil A2 Syringe with Extrusion Handle
Published
2016-06-16
Public version status
Update
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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K091647000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091647000INJECTAFILApex Dental Materials, Inc.2009-09-21EBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850194007367PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850194007367008501940073678501940073670850194007367

GMDN Terms#

Term, Definition table
TermDefinition
Self-cured dental restorative composite resinA dental restorative material consisting of a blend of glass or ceramic particles dispersed in a synthetic, self-polymerizable, organic resin matrix that is typically used to fill dental cavities or restore damaged dental tissue. It is typically a two-paste system (self-cured when put together) consisting basically of a dimethacrylate resin [(e.g., a bisphenol A and glycidylmethacrylate (BIS-GMA)]; the filler is usually made of glass, quartz, or ceramic. Typically, one paste contains an accelerator and the other a catalyst which polymerize a solid resin. This single-use product should match the colour of the original teeth for aesthetic reasons.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
036623932
Device count
1
Lot or batch
true
Expiration date on label
true

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