FDA.reportPublic FDA data

MatrixTemp Temporary Crown and Bridge Material

Primary DI
10859787002021
Brand
MatrixTemp Temporary Crown and Bridge Material
Company
ADVANTAGE DENTAL PRODUCTS INC
Model
102
Device description
Self-cure resin based impression material for the fabrication of temporary crowns and bridges
Published
2016-10-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBGCrown And Bridge, Temporary, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBGCrown And Bridge, Temporary, ResinDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10859787002021PackageGS112In Commercial Distribution
00859787002024PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085978700202110859787002021
00859787002024008597870020248597870020240859787002024

GMDN Terms#

Term, Definition table
TermDefinition
Dental crown/bridge resin, temporaryA material [e.g., polymethylmethacrylate (PMMA)] intended to make a temporary crown or bridge prosthesis for use until a permanent restoration is fabricated.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume50Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Fahrenheit73 Degrees Fahrenheit
Special Storage Condition, Specify00Use with adequate ventilation and store away from oxidizing materials
Storage Environment Temperature0 Degrees Fahrenheit73 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
248-391-1625contact@advantagedentalinc.com

Regulatory Flags#

DUNS number
607859147
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859787002062ThermTray1 Quadrant UL-LR 1122016-11-04
00859787002079ThermTray1 Quadrant UR-LL1142016-11-04
00859787002086TherTray1 3/4/-Arch UL-LR1162016-11-04
00859787002093ThermTray1 3/4/-Arch UR-LL1182016-11-04
00859787002109ThermTray1 Anterior1202016-11-04
00859787002017MatrixTemp Temporary Crown and Bridge Material1012016-10-21
00859787002024MatrixTemp Temporary Crown and Bridge Material1022016-10-21
00859787002031MatrixTemp Temporary Crown and Bridge Materail1032016-10-21
00859787002000Hemaseal & Cide 1702016-09-16
00859787002048Hemaseal & Cide - Unidose1802016-09-16
10859787002007Hemaseal & Cide 1702016-09-16
10859787002045Hemaseal & Cide - Unidose1802016-09-16
00859787002055Temporary Crown Matrix Buttons1002016-10-21
10859787002014MatrixTemp Temporary Crown and Bridge Material1012016-10-21
10859787002038MatrixTemp Temporary Crown and Bridge Materail1032016-10-21
10859787002052Temporary Crown Matrix Buttons1002016-10-21
10859787002069ThermTray1 Quadrant UL-LR 1122016-11-04
10859787002076ThermTray1 Quadrant UR-LL1142016-11-04
10859787002083TherTray1 3/4/-Arch UL-LR1162016-11-04
10859787002090ThermTray1 3/4/-Arch UR-LL1182016-11-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
EPOLPMFLAG5600PMMA CAD/CAM discPOLIDENT d.o.o.EBG2025-05-13
EPOLPMMA1270PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-08
EPOLPMMA1350PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-08
EPOLPMMA1430PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-08
EPOLPMMA0230PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0310PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0390PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0470PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0550PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0630PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0710PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0790PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0870PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0950PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0070PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-04
EPOLPMMA1030PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-04
EPOLPMMA1110PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-04
EPOLPMMA1190PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-04
EPOLKML200160DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML200200DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML201160DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML201200DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML202160DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML202200DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML203160DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML203200DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML204160DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML204200DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML205160DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML205200DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02