FDA.reportPublic FDA data

Gingivamoll Starter-Kit

Primary DI
EDET30521
Brand
Gingivamoll Starter-Kit
Company
DETAX GmbH
Model
03052
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
EDET30521PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Cosmetic silicone-liquid tissue reconstructive materialA sterile, high-grade, medical silicone fluid intended to be used in cosmetic surgery. It is typically injected under the skin to remove wrinkles and other imperfections, or to fill cavities. 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
EDET042611Ultraprint-Dental Gingiva UV 1000g042612022-10-14
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

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