Visalys CemCore Try In Paste

Primary DI
E217135901
Brand
Visalys CemCore Try In Paste
Company
Kettenbach GmbH & Co. KG
Model
13590
Catalog number
13590
Device description
Visalys CemCore Try In Paste Translucent 1 x 1,4 ml + 5 Application tips
Published
2019-11-25
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
E217135901PrimaryHIBCC0

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.

Regulatory Flags#

DUNS number
316803246
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
E217135911Visalys CemCore Try In Paste13591135912019-11-25
E217135921Visalys CemCore Try In Paste13592135922019-11-25
E217135931Visalys CemCore Try In Paste13593135932019-11-25
E217135941Visalys CemCore Try In Paste13594135942019-11-25
E217149401ProphyProtect149402026-06-08
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

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