FDA.reportPublic FDA data

Capo Natural B 3, 4 g

Primary DI
ESDG2320461
Brand
Capo Natural B 3, 4 g
Company
Schütz Dental GmbH
Model
232046
Device description
Capo Natural is a light-curing composite containing ultrafine, radiopaque glass filler and is indicated for placing fillings using adhesive techniques.
Published
2016-11-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EBCSealant, Pit And Fissure, And Conditioner
EBFMaterial, Tooth Shade, Resin
EMACement, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBCSealant, Pit And Fissure, And ConditionerDental2
EBFMaterial, Tooth Shade, ResinDental2
EMACement, DentalDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
ESDG2320461PrimaryHIBCC0

GMDN Terms#

Term, Definition table
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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315830349
Device count
1
Lot or batch
true
Expiration date on label
true

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Primary DI, Brand, Model table
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ESDG6500111FuturaJet Pink Transparent veined6500112016-09-12
ESDG6500121FuturaJet Pink Opaque6500122016-09-12
ESDG6500131FuturaJet Pink6500132016-09-12
ESDG6500141FuturaJet Pink veined6500142016-09-12
ESDG6500151FuturaJet Clear6500152016-09-12
ESDG6500201FuturaJet Pink Transparent6500202016-09-12
ESDG6500211FuturaJet Pink Transparent Veined6500212016-09-12
ESDG6500221FuturaJet Pink Opaque6500222016-09-12
ESDG6500231FuturaJet Pink6500232016-09-12
ESDG6500241FuturaJet Pink veined6500242016-09-12
ESDG6500251FuturaJet Clear6500252016-09-12
ESDG6500501FuturaJet Pink Transparent6500502016-09-12
ESDG6500611FuturaJet Liquid6500612016-09-12
ESDG6500621FuturaJet Liquid6500622016-09-12
ESDG6501101FuturaPress LT Pink Transparent6501102016-09-12
ESDG6501111FuturaPress LT Pink Transparent veined6501112016-09-12
ESDG6501121FuturaPress LT Pink Opaque6501122016-09-12
ESDG6501131FuturaPress LT Pink6501132016-09-12

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