FDA.report

Telio CAD

Primary DI
DIVO6381231
Brand
Telio CAD
Company
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Model
638123
Catalog number
638123
Device description
materials for inlays, onlays, crowns and bridges
Published
2016-12-05
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
EBGCROWN AND BRIDGE, TEMPORARY, RESIN

Product Code Classifications

CodeDeviceSpecialtyClass
EBGCrown And Bridge, Temporary, ResinDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
DIVO6381231PrimaryHIBCC0
DIVO6381230Unit of UseHIBCC0

GMDN Terms

TermDefinition
Dental crown/bridge resin, temporaryA material [e.g., polymethylmethacrylate (PMMA)] intended to make a temporary crown or bridge prosthesis for use until a permanent restoration is fabricated.

Sterilization Methods

Method

Regulatory Flags

DUNS number
448015938
Device count
5
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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Primary DIBrandCompanyProduct codePublished
08800055726946C&B 5.0 HybridARUM DENTISTRY Co., Ltd.EBG2026-03-10
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06971437944158UltraPrint Temp C&B UVGUANGZHOU HEYGEARS IMC.INCEBG2026-03-04
06971437944165UltraPrint Temp C&B UVGUANGZHOU HEYGEARS IMC.INCEBG2026-03-04
06971437944172UltraPrint Temp C&B UVGUANGZHOU HEYGEARS IMC.INCEBG2026-03-04
06971437944189UltraPrint Temp C&B UVGUANGZHOU HEYGEARS IMC.INCEBG2026-03-04
06971437944196UltraPrint Temp C&B UVGUANGZHOU HEYGEARS IMC.INCEBG2026-03-04
E235DD18B1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02
E235DD20A1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02
E235DD20B1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02
E235DD25A1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02
E235DD25A2MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02
E235DD30A1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02
E235DD30A2MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02
E235DD30B1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02
E235DD35A1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02
E235DD35A2MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02
E235D18B1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02
E235D20A1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02
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E235D30A2MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02
E235D30B1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02
E235D35A1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02
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