FDA.reportPublic FDA data

Cerec Zirconia+

Primary DI
EDD153654400050
Brand
Cerec Zirconia+
Company
DeguDent GmbH
Model
Cerec Zirconia+ mono 20/19, A4
Catalog number
5365440005
Published
2021-03-16
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
EIHPOWDER, PORCELAIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIHPowder, PorcelainDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EDD153654400050PrimaryHIBCC0

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.

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

Regulatory Flags#

DUNS number
329532225
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
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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