FDA.reportPublic FDA data

Temporary Crown Matrix Buttons

Primary DI
10859787002052
Brand
Temporary Crown Matrix Buttons
Company
ADVANTAGE DENTAL PRODUCTS INC
Model
100
Device description
Thermoplastic disk used to make custom temporary crown and bridge restorations
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
true

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
10859787002052PackageGS124In Commercial Distribution
00859787002055PrimaryGS10
00859787002222Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085978700205210859787002052
00859787002055008597870020558597870020550859787002055
00859787002222008597870022228597870022220859787002222

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, thermoplasticA thermoplastic material intended to be used in the dental laboratory to manufacture a patient-worn dental appliance (e.g., denture/denture base, orthodontic retainer, implant bars, crowns/bridges, occlusal splint, mouthguard); it might in addition be intended to fabricate non-patient worn devices (e.g., dental impression tray). The material [e.g., nylon 12 beads, polyetheretherketone (PEEK) milling blank, thermoplastic sheet] is manipulated [e.g., by melting and moulding, or computer-aided techniques (dental CAD/CAM)] to form the shape needed for the patient. After application, this material cannot be refabricated.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Fahrenheit125 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
607859147
Device count
72
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
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
10859787002021MatrixTemp Temporary Crown and Bridge Material1022016-10-21
10859787002038MatrixTemp Temporary Crown and Bridge Materail1032016-10-21
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
06942201760748FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201760946FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201760960FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761035FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761134FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761158FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761219FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761226FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761325FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761417FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761424FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761516FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761707FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761714FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761806FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761899FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761998FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201762186FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
07506338322478Nic ToneMDC DENTALEBG2026-07-20
07506338322485VIVIDMDC DENTALEBG2026-07-20
07506338322492VIVIDMDC DENTALEBG2026-07-20
07506338322508VIVIDMDC DENTALEBG2026-07-20
07506338322515VIVIDMDC DENTALEBG2026-07-20
07506338322522VIVIDMDC DENTALEBG2026-07-20
07506338322539VIVIDMDC DENTALEBG2026-07-20
07506338322546VIVIDMDC DENTALEBG2026-07-20
07506338322553VIVIDMDC DENTALEBG2026-07-20
07506338322560VIVIDMDC DENTALEBG2026-07-20
07506338322577Nic Tone, MDC DentalMDC DENTALEBG2026-07-20
07506338322584Nic Tone, MDC DentalMDC DENTALEBG2026-07-20