FDA.reportPublic FDA data

Vitacrilic®

Primary DI
B71514003006P0
Brand
Vitacrilic®
Company
FRICKE INTERNATIONAL, INC.
Model
14003-006P
Catalog number
14003-006P
Device description
Pink Tray
Published
2019-09-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBHMaterial, Impression Tray, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBHMaterial, Impression Tray, ResinDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B71514003006P0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental impression tray materialA material intended to be used to create a custom impression tray intended for filling with dental impression materials; it is not intended for the fabrication of a patient-worn dental appliance. The tray is typically made by applying the material to a preliminary plaster or stone model of the patient's teeth and gums. The material is used in cases in which a preformed impression tray is not suitable. This is a single-use device.

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
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
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
00840456206942JMUJMU DENTAL, INCEBH2026-07-09
00840456207024JMUJMU DENTAL, INCEBH2026-07-09
00840456207031JMUJMU DENTAL, INCEBH2026-07-09
00840456207048JMUJMU DENTAL, INCEBH2026-07-09
00840456207055JMUJMU DENTAL, INCEBH2026-07-09
00840456207062JMUJMU DENTAL, INCEBH2026-07-09
00840456207079JMUJMU DENTAL, INCEBH2026-07-09
00840456207086JMUJMU DENTAL, INCEBH2026-07-09
00840456207093JMUJMU DENTAL, INCEBH2026-07-09
00840456207109JMUJMU DENTAL, INCEBH2026-07-09
00840456209332JMUJMU DENTAL, INCEBH2026-07-09
00840456209349JMUJMU DENTAL, INCEBH2026-07-09
00840456209356JMUJMU DENTAL, INCEBH2026-07-09
00840456214138JMUJMU DENTAL, INCEBH2026-07-09
00840456214145JMUJMU DENTAL, INCEBH2026-07-09
00840456214152JMUJMU DENTAL, INCEBH2026-07-09
00840456214169JMUJMU DENTAL, INCEBH2026-07-09
00840456214176JMUJMU DENTAL, INCEBH2026-07-09
00840456214183JMUJMU DENTAL, INCEBH2026-07-09
00840456214190JMUJMU DENTAL, INCEBH2026-07-09
00840456214206JMUJMU DENTAL, INCEBH2026-07-09
00840456214213JMUJMU DENTAL, INCEBH2026-07-09
00840456214220JMUJMU DENTAL, INCEBH2026-07-09
00840456223680JMUJMU DENTAL, INCEBH2026-07-09
00840456223697JMUJMU DENTAL, INCEBH2026-07-09
00840456223703JMUJMU DENTAL, INCEBH2026-07-09
00840456223710JMUJMU DENTAL, INCEBH2026-07-09
00840456223727JMUJMU DENTAL, INCEBH2026-07-09
00840456223734JMUJMU DENTAL, INCEBH2026-07-09
00840456223741JMUJMU DENTAL, INCEBH2026-07-09