FDA.report

IPS Empress Direct

Primary DI
DIVO740800AN0
Brand
IPS Empress Direct
Company
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Model
740800AN
Catalog number
740800AN
Device description
Empress Direct Ref. 10x0.2g A2 Enamel, Empress Direct Ref. 10x0.2g A2 Dentin, Empress Direct Ref. 10x0.2g A3 Dentin, Empress Direct Ref. 10x0.2g A3 Enamel, Empress Direct Ref. 10x0.2g Trans 30, Empress Direct Ref. 10x0.2g Opal, Empress Direct Effect Ref. 1x1.8g Opal, SPR Empress Direct Effect Color ocker, SPR Empress Direct Effect Color weiss, AdheSE Universal 0.5ml VivaPen (BULK)
Published
2020-07-28
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
EBFMATERIAL, TOOTH SHADE, RESIN

Product Code Classifications

CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
DIVO740800AN1PrimaryHIBCC0
DVIV740800AN1PrimaryHIBCC0
DIVO740800AN0Unit of UseHIBCC0

GMDN Terms

TermDefinition
Dental composite resinA non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.

Sterilization Methods

Method

Regulatory Flags

DUNS number
448015938
Device count
64
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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