FDA.reportPublic FDA data

Ultraprint-Dental Gingiva UV 1000g

Primary DI
EDET042611
Brand
Ultraprint-Dental Gingiva UV 1000g
Company
DETAX GmbH
Model
04261
Published
2022-10-14
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
NOKMaterial, External Aesthetic Restoration, No Adhesive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NOKMaterial, External Aesthetic Restoration, No AdhesiveGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EDET042611PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental acrylic resinA non-sterile substance intended for professional use as a dental cement, luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, typically for short-term fixed prosthesis use (temporary crowns and bridges used for 6 months or less) or long-term removable prosthesis use. It consists of a self-, light-, or dual-curing acrylic resin material [e.g., polymethylmethacrylate (PMMA)]; it does not include any additional hardening fillers/components. It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
343947949
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EDET047491FREEPRINT crown A3,5 500g047492026-04-13
EDET047511FREEPRINT crown A3,5 1000g047512026-04-13
EDET047081FREEPRINT crown A3,5 1000g047082026-02-04
EDET047091FREEPRINT crown A3,5 500g047092026-02-04
EDET047541dx retainer 5 kg047542026-03-06
EDET047551dx retainer 1000g047552026-03-06
EDET030161medicalprint shell beige 2.0 1000g030162026-02-25
EDET045881VITA VIONIC® DENT RESIN A3,5 500 g045882026-02-04
EDET045891VITA VIONIC® DENT RESIN A3,5 1000 g045892026-02-04
EDET046341VITA VIONIC® BASE RESIN FLEX pink transparent 1000g046342026-02-04
EDET046351VITA VIONIC® BASE RESIN FLEX clear 1000g046352026-02-04
EDET037151luxaprint 3D mould UV red 500 g037152022-10-25
EDET045581medicalprint nobreak blue-transparent 1000g045582025-12-22
EDET045631medicalprint nobreak dark grey1000g045632025-12-22
EDET045641medicalprint nobreak green opaque 1000g045642025-12-22
EDET045681medicalprint nobreak dark neon yellow 1000g045682025-12-22
EDET045691medicalprint nobreak purple 1000g045692025-12-22
EDET045701medicalprint nobreak red-transparent 1000g045702025-12-22
EDET045741medicalprint nobreak white 1000g045742025-12-22
EDET046311medicalprint nobreak orange-transparent 1000g045312025-12-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00645517110028TrulifeTrulife LimitedNOK2022-12-31
00645517110035TrulifeTrulife LimitedNOK2022-12-31
00645517110042TrulifeTrulife LimitedNOK2022-12-31
00645517110066TrulifeTrulife LimitedNOK2022-12-31
00645517110073TrulifeTrulife LimitedNOK2022-12-31
00645517110080TrulifeTrulife LimitedNOK2022-12-31
00645517110097TrulifeTrulife LimitedNOK2022-12-31
00645517110103TrulifeTrulife LimitedNOK2022-12-31
00645517110127TrulifeTrulife LimitedNOK2022-12-31
00645517110134TrulifeTrulife LimitedNOK2022-12-31
00645517110141TrulifeTrulife LimitedNOK2022-12-31
00645517110158TrulifeTrulife LimitedNOK2022-12-31
00645517110165TrulifeTrulife LimitedNOK2022-12-31
00645517110172TrulifeTrulife LimitedNOK2022-12-31
00645517110189TrulifeTrulife LimitedNOK2022-12-31
00645517110202TrulifeTrulife LimitedNOK2022-12-31
00645517110219TrulifeTrulife LimitedNOK2022-12-31
00645517110226TrulifeTrulife LimitedNOK2022-12-31
00645517110233TrulifeTrulife LimitedNOK2022-12-31
00645517110240TrulifeTrulife LimitedNOK2022-12-31
00645517110257TrulifeTrulife LimitedNOK2022-12-31
00645517110264TrulifeTrulife LimitedNOK2022-12-31
00645517110271TrulifeTrulife LimitedNOK2022-12-31
00645517110288TrulifeTrulife LimitedNOK2022-12-31
00645517110295TrulifeTrulife LimitedNOK2022-12-31
00645517110301TrulifeTrulife LimitedNOK2022-12-31
00645517110318TrulifeTrulife LimitedNOK2022-12-31
00645517110325TrulifeTrulife LimitedNOK2022-12-31
00645517112848TrulifeTrulife LimitedNOK2022-12-31
00645517112855TrulifeTrulife LimitedNOK2022-12-31