Visalys CemCore 13574

GUDID E217135741

Visalys CemCore Translucent Normal pack 1 x 5 ml + Accessories

Kettenbach GmbH & Co. KG

Dental composite resin
Primary Device IDE217135741
NIH Device Record Key48be036a-a307-4d62-92b6-2fa50e6b1db6
Commercial Distribution StatusIn Commercial Distribution
Brand NameVisalys CemCore
Version Model Number13574
Catalog Number13574
Company DUNS316803246
Company NameKettenbach GmbH & Co. KG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE217135741 [Primary]

FDA Product Code

EBFMaterial, Tooth Shade, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-12-03
Device Publish Date2019-11-25

On-Brand Devices [Visalys CemCore]

E217135761Visalys CemCore Dark (A4) Normal pack 1 x 5 ml + Accessories
E217135751Visalys CemCore Bleach Normal pack 1 x 5 ml + Accessories
E217135741Visalys CemCore Translucent Normal pack 1 x 5 ml + Accessories
E217135731Visalys CemCore Opaque Normal pack 1 x 5 ml + Accessories
E217135721Visalys CemCore Universal (A2/A3) Normal pack 1 x 5 ml + Accessories
E21713572Visalys CemCore Universal (A2/A3) Normal pack 1 x 5 ml + Accessories
E217135701Visalys CemCore Universal (A2/A3) Starter pack 1 x 2,5 ml VCC, 2 ml TP, 2 ml RP + Accessories

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