FDA.reportPublic FDA data

Duceram® love

Primary DI
EDD153605190130
Brand
Duceram® love
Company
DeguDent GmbH
Model
Duceram love Dentine Gum 2 20g
Catalog number
5360519013
Published
2016-09-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
EIHPOWDER, PORCELAIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIHPowder, PorcelainDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EDD153605190130PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, ceramicA dental material made of ceramic materials (e.g., zirconium oxide) intended to be used to manufacture a final dental prosthesis (e.g., a dental implant, removable dentures, crown, bridge) for patient use. It is used to create implantable and removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight20Gram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00keep dry

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+49061815950Info.Degudent-de@dentsplysirona.com
+011(49)061815950Info.Degudent-de@dentsplysirona.com

Regulatory Flags#

DUNS number
329532225
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EDD153654001130Celtra ®CELTRA PRESS Starter Kit53654001132016-11-23
EDD153654301130CEREC TesseraCEREC TESSERA Starter Kit53654301132021-02-26
EDD153603112330Duceragold® KissDuceragold Kiss Dentine Bleach BL1 20g53603112332016-09-21
EDD153603112630Duceragold® KissDuceragold Kiss Dentine Bleach BL4 20g53603112632016-09-21
EDD153654340250CEREC TesseraMT A3 A16 S53654340252025-04-15
EDD153654340350CEREC TesseraMT A3,5 A16 S53654340352025-04-15
EDD153654345150CEREC TesseraMT A2 A16 L53654345152025-04-15
EDD153654345250CEREC TesseraMT A3 A16 L53654345252025-04-15
EDD153654345350CEREC TesseraMT A3,5 A16 L53654345352025-04-15
EDD153603012500Duceragold® KissDuceragold Kiss improved Paste-Opaque BL1/BL2 3ml53603012502016-09-21
EDD153603012600Duceragold® KissDuceragold Kiss improved Paste-Opaque BL3/BL4 3ml53603012602016-09-21
EDD153603112430Duceragold® KissDuceragold Kiss Dentine Bleach BL2 20g53603112432016-09-21
EDD153603112530Duceragold® KissDuceragold Kiss Dentine Bleach BL3 20g53603112532016-09-21
EDD153654312450CEREC TesseraHT A4, C1453654312452025-03-18
EDD153654315450CEREC TesseraMT A4, C1453654315452025-03-18
EDD153654315650CEREC TesseraMT B2, C1453654315652025-03-18
EDD153654316050CEREC TesseraMT C2, C1453654316052025-03-18
EDD153654600010CERECMono A153654600012025-02-26
EDD153654600020CERECMono A253654600022025-02-26
EDD153654600030CERECMono A353654600032025-02-26

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