FDA.report

IPS Style Ceram

Primary DI
DIVO701899EN1
Brand
IPS Style Ceram
Company
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Model
701899EN
Catalog number
701899EN
Device description
"IPS Style Ceram Paste Opaq 5g A2, IPS Style Ceram Deep Dentin A2 5g, IPS Style Ceram Dentin A2 5g, IPS Style Ceram Incisal I2 5g, IPS Style Ceram Transpa neutral 5g, IPS Style Ceram Mamelon light 5g, IPS Style Ceram Occ. Dentin orange 5g, IPS Style Ceram Opal Effect 1 5g, IPS Style Ceram One 2 5g, Ivocolor Shade Dentin SD2 3g, IPS Ivocolor Essence 1.8g E01 white, IPS Ivocolor Essence 1.8g E04 sunset, IPS Ivocolor Glaze Paste 3g, Ivocolor Mixing Liquid allround 15ml, IPS Paste Opaq. Liquid 15ml, Build-Up Liquid 15ml allround "
Published
2019-11-12
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
DIVO701899EN1PrimaryHIBCC0
DIVO701899EN0Unit 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
16
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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07615208590296Tetric CAD6921946921942026-01-13
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07615208590265Tetric CAD6921926921922026-01-13

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