FDA.reportPublic FDA data

CEREC Tessera

Primary DI
EDD153654301130
Brand
CEREC Tessera
Company
DeguDent GmbH
Model
CEREC TESSERA Starter Kit
Catalog number
5365430113
Published
2021-02-26
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
EDD153654301130PrimaryHIBCC0

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
Kit
true
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
EDD153671117130Cercon® ceram KissCercon ceram Kiss ht Dentine ht DA2, 20 g53671117132016-09-21
EDD153654001130Celtra ®CELTRA PRESS Starter Kit53654001132016-11-23
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800121750769Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121750776Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121750806Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121750837Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121750844Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121750875Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121750882Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121750899Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751117Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751124Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751131Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751148Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751193Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751209Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751254Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751261Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751278Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751285Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751339Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751346Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751353Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751360Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751377Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751384Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751803Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751810Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751827Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751834Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751889Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751896Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27