FDA.reportPublic FDA data

Prime Dent Tray Adhesive Blue

Primary DI
00817441023433
Brand
Prime Dent Tray Adhesive Blue
Company
PRIME DENTAL
Model
017-020
Device description
Prime Dent Tray Adhesive Blue
Published
2017-01-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ELWMaterial, Impression

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELWMaterial, ImpressionDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817441023433PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817441023433008174410234338174410234330817441023433

GMDN Terms#

Term, Definition table
TermDefinition
Dental impression adhesiveA liquid material specifically made to give adhesion of an impression material to the impression tray. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
027480775
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
00817441020005Prime-Dent Visible Light Cure Nano-Hybrid Composite001-6102016-08-10
00817441022658Prime Dent Light Cure One Step Dentin/Enamel Bonding Adhesive006-0302023-11-21
00817441023136Prime Dent Etchant Liquid008-0402023-11-21
00817441022269Prime-CrownA12019-11-06
00817441023549Scott's Select RC Cream 2-9gm Syringe199-10362016-09-26
00817441020012Prime Dent Visible Light Cure Nano Hybrid Composite Shade001-601A12019-11-06
00817441020029Prime Dent Visible Light Cure Nano Hybrid Composite 001-601A22019-11-06
00817441023556Prime-Core Chemical Cure Core Build Up003-0182017-01-04
00817441020326Prime Dent Visible Light Cure Hybrid Composite Shade A3001-001A32017-01-04
00817441020524Prime Dent Visible Light Cure Hybrid Composite Shade A2001-001A12017-01-04
00817441020548Prime Dent Flowable Composite Shade A3.5004-010A3.52017-01-04
00817441020722Prime Dent Flowable Composite Shade A1004-010A12017-01-04
00817441020739Prime Dent Flowable Composite Shade A2004-101A22017-01-04
00817441020999Prime Dent Visible Light Cure Micro Hybrid Composite001-4142017-01-04
00817441023532Scott's Select Temporary Cement NE Jars199-10092016-09-26
00817441023563Prime-Core DC Automix Core Build Up Material003-0612017-01-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08056640080997Ormadent PuttyMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081093OrmactivatorMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081109OrmactivatorMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081161OrmamaxMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081185OrmamaxMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081598Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081604Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081611Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081642Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081666Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081673Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081734Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081741Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081802Ormalab 75MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081819Ormalab 75MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081826Ormalab 75MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081833Ormalab 75MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081925Ormalab 85MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081994Ormalab 95MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640082007Ormalab 95MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640082014Ormalab 95MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640082038Ormalab 95MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640082601Ormalab 85MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640082991AlginmajorMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640083042AlginmajorMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640083080AlginmaxMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640083134AlginmaxMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640083141AlginmaxMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640083196AlginmaxMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640083202AlginkidMAJOR PRODOTTI DENTARI SPAELW2026-10-20