FDA.report

IPS E.MAX CAD

Primary DI
DIVO690811AL0
Brand
IPS E.MAX CAD
Company
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Model
690811AL
Catalog number
690811
Device description
IPS e.max CAD for PrograMill I12 block, IPS e.max CAD for PrograMill C14 block, IPS e.max CAD for PrograMill B32 block, IPS Empress CAD for PrograMill I12 block, IPS Empress CAD for PrograMill C14 block, IPS Empress CAD for PrograMill C14 L block, IPS e.max ZirCAD for PrograMill C17 block, IPS e.max ZirCAD for PrograMill B45 block, Telio CAD for PrograMill B40L block, IPS Object Fix Putty, IPS e.max CAD Crystall./Glaze Liquid, IPS e.max CAD Crystall./Stains, IPS e.max CAD Crystall./Glaze Paste Fluo, IPS e.max CAD Crystall./Shade, IPS e.max CAD Crystallization Tray, Telio CS Desensitizer, SpeedCEM Plus, Adhese Universal, Variolink Esthetic DC, Monobond Etch & Prime, Ivoclean, Liquid Strip, var. accessories
Published
2020-03-02
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

Related Records

Product Codes

CodeName
EIHPOWDER, PORCELAIN

Product Code Classifications

CodeDeviceSpecialtyClass
EIHPowder, PorcelainDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
DIVO690811AL1PrimaryHIBCC0
DIVO690811AL0Unit of UseHIBCC0

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
448015938
Device count
19
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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07615208482423OptraSculpt759595AN759595AN2026-03-13
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07615208482768OptraSculpt760477AN760477AN2026-03-13
07615208315349Modeling Liquids Ceramic7015887015882026-03-05
07615208338027Modeling Liquids Ceramic6733746733742026-03-05
07615208338058Modeling Liquids Ceramic6733716733712026-03-05
07615208374292Modeling Liquids Ceramic6053666053662026-03-05
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07615208445602OptraSculpt683068AN683068AN2026-01-15
07615208486254OptraSculpt639793AN639793AN2026-01-15
07615208445947OptraSculpt639792AN639792AN2026-01-15
07615208590296Tetric CAD6921946921942026-01-13
07615208590258Tetric CAD6921936921932026-01-13
07615208590265Tetric CAD6921926921922026-01-13

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