FDA.reportPublic FDA data

DenFil

Primary DI
08809254450416
Brand
DenFil
Company
VERICOM CO., LTD.
Model
DF104-B000
Device description
Resin-based dental restorative material; DenFil A2/A3/A3.5/B2/B3(each 4g x 1syringe), BC Plus 5ml x 1 bottle, DenFil Etchant-37 3ml x 1 syringe
Published
2016-11-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBFMaterial, Tooth Shade, Resin
KLEAgent, Tooth Bonding, Resin

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809254450416PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809254450416088092544504168809254450416

GMDN Terms#

Term, Definition table
TermDefinition
Dental etching solutionAn acid solution, in liquid or gel form, intended to be used to create a retentive surface for a dental composite, adhesive, or a pit and fissure sealant. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius27 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+82314412881vericom@vericom.co.kr

Regulatory Flags#

DUNS number
689698269
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809254452571Dual CoreDC118-M0BL2026-05-27
08809254452618Dual CoreDC118-M0NA2026-05-27
08809254453875Dual CoreDC118-M0NA2026-05-27
08809254453943Dual CoreDC118-M0BL2026-05-27
08800123819730Well-Root PTWT225-SE002025-11-27
08800123819747Well-Root PTWT202-KE002025-11-27
08800123819754Well-Root PTWT201-EE002025-11-27
08809254459402Well-Root PTWT225-S0002025-11-27
08809254459419Well-Root PTWT202-K0002025-11-27
08809254453776Vonflex S PuttyVF305-S0002023-08-17
08809254451604DenFil Etchant-37ET125-B0002016-11-01
08809254451635DenFil Etchant-37ET115-E0002016-11-01
08809254451666DenFil Etchant-37ET105-R0002016-11-01
08809254451697DenFil Etchant-37ET103-R0002016-11-01
08809254451703DenFil Etchant-37ET136-K0002016-11-01
08809254451710DenFil Etchant-37ET130-B0002016-11-01
08809254451741DenFil Etchant-37ET101-EC002016-11-01
08809254451802Eco-SES105-K0002016-11-01
08809254452434DenFil Etchant-37ET148-K0002016-11-01
08809254454360DenFil Etchant-37ET105-S0002016-11-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00195062160332Build-It FRKerr CorporationEBF2026-10-27
00195062160349Build-It FRKerr CorporationEBF2026-10-27
00195062160356Build-It FRKerr CorporationEBF2026-10-27
00195062160363Build-It FRKerr CorporationEBF2026-10-27
00195062160370Build-It FRKerr CorporationEBF2026-10-27
00195062160387Build-It FRKerr CorporationEBF2026-10-27
00195062160394Build-It FRKerr CorporationEBF2026-10-27
00195062160400Build-It FRKerr CorporationEBF2026-10-27
00195062160417Build-It FRKerr CorporationEBF2026-10-27
00195062160424Build-It FRKerr CorporationEBF2026-10-27
00195062160431Build-It FRKerr CorporationEBF2026-10-27
00195062160448Build-It FRKerr CorporationEBF2026-10-27
00195062160455Build-It FRKerr CorporationEBF2026-10-27
00195062160462Build-It FRKerr CorporationEBF2026-10-27
00195062160479Build-It FRKerr CorporationEBF2026-10-27
00195062160486Build-It FRKerr CorporationEBF2026-10-27
00195062160493Build-It FRKerr CorporationEBF2026-10-27
06970006745660Light Cure Dental AdhesiveRizhao HuGe Biomaterials Company, Ltd.KLE2026-10-25
06970006745677Universal Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746568Phosphoric Acid Etching GelRizhao HuGe Biomaterials Company, Ltd.KLE2026-10-25
06970006746575TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746582TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746599TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746605TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746612TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746629TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746636TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746643TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746650TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746667TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25