FDA.reportPublic FDA data

Gingivamoll

Primary DI
00842092112366
Brand
Gingivamoll
Company
Preat Corporation
Model
0906405
Catalog number
0906405
Device description
Gingivamoll Repair Material 15g
Published
2022-10-25
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
00842092112366PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842092112366008420921123668420921123660842092112366

GMDN Terms#

Term, Definition table
TermDefinition
Dental prosthesis veneer resinA dental resin composite material intended to be used for veneering a restorative dental prosthesis (e.g., crown, bridge, fixed or removable denture); some types may be used as stains to apply colour to the dental appliance. After application, this material cannot be reused.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800) 232-7732info@preat.com

Regulatory Flags#

DUNS number
117776048
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
00842092170199Preat9001230-109001230-102026-06-09
00842092174999Preat9003731-1009003731-1002026-06-09
00842092187722Preat7100033-27100033-22026-06-08
00842092116906Implant Prosthetics800125080012502016-09-16
00842092117217Implant Prosthetics800165080016502016-09-16
00842092117491Implant Prosthetics800055080005502016-09-16
00842092110669FR Attachments070204007020402023-07-05
00842092112076Preat06000F906000F92022-10-25
00842092112113Preat Implant Prosthetics0600F130600F132023-07-03
00842092122396Preat Implant Prosthetics800123780012372022-11-22
00842092155844Implantlink090751009075102022-10-25
00842092167601Preat0600F160600F162022-10-25
00842092167618Preat060406606040662022-10-25
00842092172544Preat010900301090032022-10-24
00842092172551Preat010900501090052022-10-24
00842092175590Preat010200701020072022-10-25
00842092175606Preat010200801020082022-10-25
00842092176696Preci-Clix01004TI01004TI2022-10-27
00842092110577Mays020006002000602023-10-17
00842092110737Splintastik020000102000012023-10-17

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