FDA.reportPublic FDA data

Visalys CemCore Try In Paste

Primary DI
E217135931
Brand
Visalys CemCore Try In Paste
Company
Kettenbach GmbH & Co. KG
Model
13593
Catalog number
13593
Device description
Visalys CemCore Try In Paste Opaque 1 x 1,4 ml + 5 Application tips
Published
2019-11-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
EBFMaterial, Tooth Shade, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E217135931PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
316803246
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
E217119291Futar11929119292026-04-02
E217150601Visalys Bulk Fill150602026-03-05
E217150611Visalys Bulk Fill150612026-03-05
E217150621Visalys Bulk Fill150622026-03-05
E217150681Visalys Bulk150682026-03-05
E217150761Visalys BioCeramic Block15076150762026-01-09
E217150751Visalys BioCeramic Block150752026-01-19
E217150851Visalys BioCeramic Block15085150852026-01-19
E217150701Visalys BioCeramic Block15070150702026-01-09
E217150711Visalys BioCeramic Block15071150712026-01-09
E217150721Visalys BioCeramic Block15072150722026-01-09
E217150731Visalys BioCeramic Block15073150732026-01-09
E217150741Visalys BioCeramic Block15074150742026-01-09
E217150801Visalys BioCeramic Block15080150802026-01-09
E217150811Visalys BioCeramic Block15081150812026-01-09
E217150821Visalys BioCeramic Block15082150822026-01-09
E217150831Visalys BioCeramic Block15083150832026-01-09
E217150841Visalys BioCeramic Block15084150842026-01-09
E217150861Visalys BioCeramic Block15086150862026-01-09
E217150871Visalys BioCeramic Block15087150872026-01-09

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