FDA.reportPublic FDA data

DIAFIL

Primary DI
08806383541046
Brand
DIAFIL
Company
DiaDent Group International
Model
B3 Refill Package
Catalog number
A2009-2008
Device description
DiaFil & DiaFil Capsule is a composite resin for esthetic restorative.
Published
2026-10-07
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

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
08806383541046PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806383541046088063835410468806383541046

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
Handling Environment Temperature00
Special Storage Condition, Specify00Keep Dry and Keep away from Sunlight.

Regulatory Flags#

DUNS number
687789453
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
08806383540995DIAFILA3 Refill PackageA2009-20032026-10-07
08806383541008DIAFILA3.5 Refill PackageA2009-20042026-10-07
08806383541015DIAFILA4 Refill PackageA2009-20052026-10-07
08806383541022DIAFILB1 Refill PackageA2009-20062026-10-07
08806383541039DIAFILB2 Refill PackageA2009-20072026-10-07
08806383541053DIAFILC2 Refill PackageA2009-20092026-10-07
08806383541060DIAFILC3 Refill PackageA2009-20102026-10-07
08806383541091DIAFILCL Refill PackageA2009-20132026-10-07
08806383541107DIAFILB4 Refill PackageA2009-20142026-10-07
08806383541114DIAFILC1 Refill PackageA2009-20152026-10-07
08806383541121DIAFILC4 Refill PackageA2009-20162026-10-07
08806383541138DIAFILD1 Refill PackageA2009-20172026-10-07
08806383541145DIAFILD2 Refill PackageA2009-20182026-10-07
08806383541152DIAFILD3 Refill PackageA2009-20192026-10-07
08806383541169DIAFILD4 Refill PackageA2009-20202026-10-07
08806383541176DIAFILCapsule Type A1A2009-40012026-10-07
08806383541183DIAFILCapsule Type A2A2009-40022026-10-07
08806383541190DIAFILCapsule Type A3A2009-40032026-10-07
08806383541206DIAFILCapsule Type A3.5A2009-40042026-10-07
08806383541213DIAFILCapsule Type A4A2009-40052026-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197998226724Solventum™ Protemp™Solventum Germany GmbHEBF2026-10-08
08806383540995DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541008DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541015DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541022DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541039DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541053DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541060DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541091DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541107DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541114DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541121DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541138DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541145DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541152DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541169DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541176DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541183DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541190DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541206DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541213DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541220DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541237DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541244DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541251DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541268DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541299DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541305DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541312DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541329DIAFILDiaDent Group InternationalEBF2026-10-07