LuxaCrown

Primary DI
EDMG1209751
Brand
LuxaCrown
Company
DMG Chemisch-Pharmazeutische Fabrik GmbH
Model
120975
Catalog number
120975
Device description
Self-curing Composite for the fabrication of semipermanent crowns and bridges. The material is mixed automatically. Content: 1 cartridge @ 50 ml paste, accessories. Color: B3.
Published
2019-06-11
Public version status
New
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
POWCrown And Bridge, Long-Term Temporary, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
POWCrown And Bridge, Long-Term Temporary, ResinDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EDMG1209751PackageHIBCC1In Commercial Distribution
EDMG1209750PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental composite resinA non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a dry place. Keep away from direct sunlight.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
201-894-5505eanagnostos@dmg-america.com

Regulatory Flags#

DUNS number
320744915
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
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
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EDMG1104000Luxatemp® Automix Plus1104001104002016-09-21
EDMG1104010Luxatemp® Automix Plus1104011104012016-09-21
EDMG1104020Luxatemp® Automix Plus1104021104022016-09-21
EDMG1104030Luxatemp® Automix Plus1104031104032016-09-21
EDMG1104040Luxatemp® Automix Plus1104041104042016-09-21
EDMG1104060Luxatemp® Automix Plus1104061104062016-09-21
EDMG1105850Luxatemp® Fluorescence1105851105852016-09-21
EDMG1105860Luxatemp® Fluorescence1105861105862016-09-21
EDMG1105870Luxatemp® Fluorescence1105871105872016-09-21
EDMG1105880Luxatemp® Fluorescence1105881105882016-09-21
EDMG1105890Luxatemp® Fluorescence1105891105892016-09-21
EDMG1107100Luxatemp® Fluorescence1107101107102016-09-21
EDMG1107190Luxatemp® Fluorescence1107191107192016-09-23
EDMG1107220Luxatemp® Fluorescence1107221107222016-09-23
EDMG1107230Luxatemp® Fluorescence1107231107232016-09-23
EDMG2123841LuxaBond - Total Etch2123842123842016-09-23
EDMG2133201TECO2133202133202016-09-22
EDMG2130801Vitique2130802130802016-09-22

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D800TMAB0108Temp PremiumZIRKONZAHN SRLPOW2018-07-25
D800TMAB0110Temp PremiumZIRKONZAHN SRLPOW2018-07-25
D800TMAB0112Temp PremiumZIRKONZAHN SRLPOW2018-07-25
D800TMAB0114Temp PremiumZIRKONZAHN SRLPOW2018-07-25
D800TMAB0116Temp PremiumZIRKONZAHN SRLPOW2018-07-25
D800TMAB0118Temp PremiumZIRKONZAHN SRLPOW2018-07-25
D800TMAB0120Temp PremiumZIRKONZAHN SRLPOW2018-07-25
D800TMAB0122Temp PremiumZIRKONZAHN SRLPOW2018-07-25
D800TMAB0124Temp PremiumZIRKONZAHN SRLPOW2018-07-25
D800TMAB0126Temp PremiumZIRKONZAHN SRLPOW2018-07-25
D800TMAB0128Temp PremiumZIRKONZAHN SRLPOW2018-07-25
D800TMAB0130Temp PremiumZIRKONZAHN SRLPOW2018-07-25
D800TMAB0208Temp PremiumZIRKONZAHN SRLPOW2018-07-25
D800TMAB0210Temp PremiumZIRKONZAHN SRLPOW2018-07-25
D800TMAB0212Temp PremiumZIRKONZAHN SRLPOW2018-07-25
D800TMAB0214Temp PremiumZIRKONZAHN SRLPOW2018-07-25