FDA.reportPublic FDA data

Visalys CemCore

Primary DI
E217135701
Brand
Visalys CemCore
Company
Kettenbach GmbH & Co. KG
Model
13570
Catalog number
13570
Device description
Visalys CemCore Universal (A2/A3) Starter pack 1 x 2,5 ml VCC, 2 ml TP, 2 ml RP + Accessories
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
KLEAgent, Tooth Bonding, Resin

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E217135701PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental composite resin kitA collection of non-sterile substances intended for professional use during dental restoration and prosthesis installation/repair which includes composite resin material and additional materials to support restoration (e.g., etching solution, bonding agent, primer, prosthesis bonding agents, unfilled resin sealant/coating agents), and may include dedicated disposable devices associated with application; it does not include non-resin-based cements nor dental prosthesis. 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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Primary DI, Brand, Company table
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08809518340668Once-Fil FlowMEDICLUS CO.,LTDEBF2026-05-28
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08809254453943Dual CoreVERICOM CO., LTD.EBF2026-05-27
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