FDA.reportPublic FDA data

Vitacrilic®

Primary DI
B715050180480
Brand
Vitacrilic®
Company
FRICKE INTERNATIONAL, INC.
Model
05018-048
Catalog number
05018-048
Device description
Light Fibered Self Curing
Published
2020-11-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBIResin, Denture, Relining, Repairing, Rebasing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBIResin, Denture, Relining, Repairing, RebasingDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B715050180480PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, resinA resin intended to be used in the dental laboratory to manufacture a patient-worn dental prosthesis or appliance (e.g., denture base, occlusal splint/night guard), that either: 1) polymerizes under heat (heat-cured), light (light-cured), and/or after a period of time (self-cured); or 2) can be shaped by a dental mill [e.g., based on computer-aided design/computer-aided manufacturing (CAD/CAM) technology]. It may in addition be intended to fabricate non-patient-worn devices (e.g., drilling templates using 3-D printing). After application, this material cannot be refabricated.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight48Gram

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
630-540-1900customerservice@frickedental.com

Regulatory Flags#

DUNS number
957630726
Device count
1
Premarket exempt
true
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
B71501033006P0Vitacrilic®01033-006P01033-006P2019-07-23
B71501056600P0Vitacrilic®01056-600P01056-600P2019-05-13
B71505032001P0Vitacrilic®05032-001P05032-001P2019-08-15
B71505032006P0Vitacrilic®05032-006P05032-006P2019-08-15
B71505033001P0Vitacrilic®05033-001P05033-001P2020-11-09
B715050390480Vitacrilic®05039-04805039-0482020-11-14
B71505051006P0Vitacrilic®05051-006P05051-006P2019-10-10
B71505060006P0Vitacrilic®05060-006P05060-006P2019-08-19
B71505070001P0HI-I®05070-001P05070-001P2019-10-10
B715050700480HI-I®05070-04805070-0482019-10-10
B71505070600P0HI-I®05070-600P05070-600P2019-10-10
B71507002001P0HI-I®07002-001P07002-001P2019-08-15
B71507002006P0HI-I®07002-006P07002-006P2019-08-15
B71507014001P0HI-I®07014-001P07014-001P2019-08-07
B71507014006P0HI-I®07014-006P07014-006P2019-08-07
B71507026001P0HI-I®07026-001P07026-001P2019-08-20
B71507026006P0HI-I®07026-006P07026-006P2019-08-20
B715070260480HI-I®07026-04807026-0482020-11-14
B71507028025P0HI-I®07028-025P07028-025P2020-11-14
B715070290060HI-I®07029-00607029-0062019-08-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08720604634235Vertex-Dental BVVertex-Dental B.V.EBI2026-09-24
08720604634242Vertex-Dental BVVertex-Dental B.V.EBI2026-09-24
06971437943618UltraPrint Flexible Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-08-27
06971437943625UltraPrint Flexible Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-08-27
06971437943649UltraPrint Flexible Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-08-27
06971437943700UltraPrint Flexible Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-08-27
06971437943748UltraPrint Flexible Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-08-27
08685313736208DentaFab3BFAB TEKNOLOJI ANONIM SIRKETIEBI2026-08-25
08685313736215DentaFab3BFAB TEKNOLOJI ANONIM SIRKETIEBI2026-08-25
08685313736222DentaFab3BFAB TEKNOLOJI ANONIM SIRKETIEBI2026-08-25
00883205041883UltraCemULTRADENT PRODUCTS, INC.EBI2026-08-22
07630813462523XPLEX BaseCandulor AGEBI2026-07-28
00850061175175Denture Base Resin V2FORMLABS OHIO INC.EBI2026-07-21
00850061175182Denture Base Resin V2FORMLABS OHIO INC.EBI2026-07-21
00850061175199Denture Base Resin V2FORMLABS OHIO INC.EBI2026-07-21
07615208585728Ivotion BaseIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
07615208585735IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
07615208585742IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
07615208585759IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
07615208585766IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
07615208585773IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
07615208585780IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
07615208585797IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
07615208585803IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
07615208585810IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
07615208585827IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
07615208585834IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
07615208585841IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
D14307560147448040Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBI2026-05-29
D14307560147448110Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBI2026-05-29