FDA.reportPublic FDA data

Vitacrilic®

Primary DI
B71505053006P0
Brand
Vitacrilic®
Company
FRICKE INTERNATIONAL, INC.
Model
05053-006P
Catalog number
05053-006P
Device description
Williams Special Self Curing
Published
2019-11-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
B71505053006P0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, curedA resin that polymerizes under heat (heat-cured), light (light-cured), and/or after a period of time (self-cured) intended to be used in the dental laboratory to manufacture a patient-worn dental appliance (e.g., denture base, occlusal splint/night guard); it may in addition be intended to fabricate non-patient-worn devices (e.g., drilling templates using 3-D printing). It consists of a reactive component (e.g., acrylic monomer, reactive polymer) that hardens via polymerization [or vulcanization]. Reinforcing fillers may be included in the resin to increase its strength and/or durability. After application, this material cannot be refabricated.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight6Pound

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
957630726
Device count
1
DM exempt
false
Premarket exempt
true
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B71501033006P0Vitacrilic®01033-006P01033-006P2019-07-23
B71501056600P0Vitacrilic®01056-600P01056-600P2019-05-13
B715050180480Vitacrilic®05018-04805018-0482020-11-09
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842326128095DuraflexThe Myerson Company LimitedEBI2026-05-26
00842326128101DuraflexThe Myerson Company LimitedEBI2026-05-26
00842326128118DuraflexThe Myerson Company LimitedEBI2026-05-26
00842326128125DuraflexThe Myerson Company LimitedEBI2026-05-26
00815967025917RodinPac-Dent, Inc.EBI2026-03-23
00815967029342RodinPac-Dent, Inc.EBI2026-03-23
00815967029359RodinPac-Dent, Inc.EBI2026-03-23
00815967029366RodinPac-Dent, Inc.EBI2026-03-23
00815967029373RodinPac-Dent, Inc.EBI2026-03-23
06971437942314UltraPrint Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-05
06971437942321UltraPrint Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-05
06971437942338UltraPrint Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-05
06971437942352UltraPrint Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-05
06971437942376UltraPrint Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-05
06971437942383UltraPrint Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-05
06971437942390UltraPrint Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-05
06971437942406UltraPrint Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-05
06971437942413UltraPrint Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-05
06971437942192UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-04
06971437942208UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-04
06971437942215UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-04
06971437942222UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-04
06971437942239UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-04
06971437942246UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-04
06971437942253UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-04
06971437942260UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-04
06971437942277UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-04
06971437942284UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-04
06971437942291UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-04
06971437942307UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-04