FDA.reportPublic FDA data

Ceramco 3

Primary DI
D0013039201
Brand
Ceramco 3
Company
Dentsply Professional
Model
303920
Catalog number
303920
Device description
Ceramco 3 Shade Series Dentin 423 10g
Published
2024-10-03
Public version status
Update
Distribution status
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
D0013039201PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)243-1942Prosthetics-Regualtory@dentsplysirona.com

Regulatory Flags#

DUNS number
144140845
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D00381950011Cavitron®81950012016-09-23
D00381702011Cavitron®817020181702012026-01-20
D00381702031Cavitron®81702032016-09-23
D00377602011Cavitron®77602012016-09-23
D00377602051Cavitron®77602052016-09-23
D0013032800Ceramco 33032803032802026-02-20
D0013031901Ceramco 33031903031902024-10-02
D0013032801Ceramco 33032803032802024-10-02
D0013034001Ceramco 33034003034002024-10-02
D0013034601Ceramco 33034603034602024-10-02
D0013035601Ceramco 33035603035602024-10-03
D0013035701Ceramco 33035703035702024-10-03
D0013036301Ceramco 33036303036302024-10-03
D0013038401Ceramco 33038403038402024-10-03
D0013050011Ceramco 33050013050012024-10-02
D0013050051Ceramco 33050053050052024-10-02
D0013050201Ceramco 33050203050202024-10-02
D0013050221Ceramco 33050223050222024-10-02
D0013051041Ceramco 33051043051042024-10-02
D0013051151Ceramco 33051153051152024-10-02

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Primary DI, Brand, Company table
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