FDA.report

IPS InLine

Primary DI
DIVO631849EN1
Brand
IPS InLine
Company
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Model
631849EN
Catalog number
631849EN
Device description
IPS InLine System Opaquer, IPS InLine System Shade, IPS InLine System Shade Incisal, IPS InLine System Stains, IPS InLine System Glaze Paste, IPS InLine One Dentcisal Powder, IPS InLine System Add-on (690°C), IPS Inline System Build-Up Liquid P/L, IPS InLine System Glaze and Stain Liquid, IPS InLine System Opaquer Liquid, IPS Model Sealer, IPS Ceramic Separating Liquid, var. accessories
Published
2018-09-27
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
false

Related Records

Product Codes

CodeName
EIHPOWDER, PORCELAIN

Product Code Classifications

CodeDeviceSpecialtyClass
EIHPowder, PorcelainDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
DIVO631849EN1PrimaryHIBCC0

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
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
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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07615208486254OptraSculpt639793AN639793AN2026-01-15
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07615208590296Tetric CAD6921946921942026-01-13
07615208590258Tetric CAD6921936921932026-01-13
07615208590265Tetric CAD6921926921922026-01-13

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