FDA.report

Cercon®

Primary DI
EDD15366102012
Brand
Cercon®
Company
DeguDent GmbH
Model
Cercon xt C2 disk 12
Catalog number
5366102012
Published
2017-03-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
EIHPOWDER, PORCELAIN

Product Code Classifications

CodeDeviceSpecialtyClass
EIHPowder, PorcelainDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
EDD15366102012PrimaryHIBCC0

GMDN Terms

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

TypeValueUnit
Outer Diameter105Millimeter

Sterilization Methods

Method

Contacts

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

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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
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
EDD153654600040CERECMono A3.553654600042025-02-26
EDD153654600050CERECMono A453654600052025-02-26
EDD153654600060CERECMono B153654600062025-02-26
EDD153654600070CERECMono B253654600072025-02-26
EDD153654600080CERECMono B353654600082025-02-26
EDD153654600110CERECMono C253654600112025-02-26
EDD153654600120CERECMono C353654600122025-02-26
EDD153654600150CERECMono D353654600152025-02-26

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