FDA.report

Capo Bulk Fill Compules

Primary DI
ESDG2321111
Brand
Capo Bulk Fill Compules
Company
Schütz Dental GmbH
Model
232111
Device description
Light-curing, flowable dental filling composite
Published
2016-09-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
EBFMaterial, Tooth Shade, Resin

Product Code Classifications

CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
ESDG2321111PrimaryHIBCC0

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.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius25 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
315830349
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
ESDG6875531CoCr laser welding wire 0.35 mm6875532017-01-30
ESDG6875541CoCr laser welding wire 0.5 mm6875542017-01-30
ESDG6246711Tizian Ceramic Opaque Dentin A26246712016-09-08
ESDG6246721Tizian Ceramic Opaque Dentin A36246722016-09-08
ESDG6246731Tizian Ceramic Opaque Dentin A3.56246732016-09-08
ESDG6246741Tizian Ceramic Opaque Dentin A46246742016-09-08
ESDG6246761Tizian Ceramic Opaque Dentin B26246762016-09-08
ESDG6246771Tizian Ceramic Opaque Dentin B36246772016-09-08
ESDG6246801Tizian Ceramic Opaque Dentin C26246802016-09-08
ESDG6246811Tizian Ceramic Opaque Dentin C36246812016-09-08
ESDG6246831Tizian Ceramic Opaque Dentin D26246832016-09-08
ESDG6246861Tizian Ceramic Transparent Tclear TC6246862016-09-08
ESDG6246871Tizian Ceramic Transparent Tclear TC6246872016-09-08
ESDG6246881Tizian Ceramic Transparent Orange T36246882016-09-08
ESDG6246891Tizian Ceramic Transparent Brown T46246892016-09-08
ESDG6246901Tizian Ceramic Transparent Grey T56246902016-09-08
ESDG6246911Tizian Ceramic Transparent Blue T66246912016-09-08
ESDG6246921Tizian Ceramic Transparent Light-Blue T76246922016-09-08
ESDG6247011Tizian Ceramic Opaquer A16247012016-09-08
ESDG6247021Tizian Ceramic Opaquer A26247022016-09-08

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