Creation Willi Geller 620039

GUDID ECWG6200391

ZI-CT/ Transpa NT neutral

KLEMA Dentalprodukte GmbH

Dental appliance fabrication material, ceramic
Primary Device IDECWG6200391
NIH Device Record Key7e30d6c3-c93b-4c2c-88e0-81f203cd1fdc
Commercial Distribution StatusIn Commercial Distribution
Brand NameCreation Willi Geller
Version Model Number620039
Catalog Number620039
Company DUNS301063590
Company NameKLEMA Dentalprodukte GmbH
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 Usefalse
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCECWG6200391 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EIHPowder, Porcelain

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-24
Device Publish Date2017-01-16

On-Brand Devices [Creation Willi Geller]

ECWGC300300V651Creapearl C3 V65
ECWGB200300V651Creapearl B2 V65
ECWGA351400U701Creapearl A3,5 U7
ECWGA351100U101Creapearl A3,5 U1
ECWGA350800A751Creapearl A3,5 A75
ECWGA350400V681Creapearl A3,5 V68
ECWGA350300V651Creapearl A3,5 V65
ECWGA301500U901Creapearl A3 U9
ECWGA301200U301Creapearl A3 U3
ECWGA301000A791Creapearl A3 A79
ECWGA300900A781Creapearl A3 A78
ECWGA300800A751Creapearl A3 A75
ECWGA300700A731Creapearl A3 A73
ECWGA300600A711Creapearl A3 A71
ECWGA300500V691Creapearl A3 V69
ECWGA201500U901Creapearl A2 U9
ECWGA201000A791Creapearl A2 A79
ECWGA200900A781Creapearl A2 A78
ECWGA200800A751Creapearl A2 A75
ECWGA200100V611Creapearl A2 V61
ECWGA100900A781Creapearl A1 A78
ECWG7005511CP/ Enamel Intensive SI-01+
ECWG7005411CP/ Enamel Intensive SI-01 light yellow
ECWG7005271CP/ Enamel E57
ECWG6521691ZI-F/ Approx. Dentine AD-2 orange
ECWG6521681ZI-F/ Approx. Dentine AD-1 light yellow
ECWG6521561ZI-F/ Neck Transpa HT-56 ochre
ECWG6521541ZI-F/ Neck Transpa HT-54 honey
ECWG6521531ZI-F/ Neck Transpa HT-53 sand
ECWG6521521ZI-F/ Neck Transpa HT-52 kaki
ECWG6521511ZI-F/ Neck Transpa HT-51 iridescent
ECWG6521441ZI-F/ Opaque Dentine OD-44 cuba
ECWG6521431ZI-F/ Opaque Dentine OD-43 ivory
ECWG6521411ZI-F/ Opaque Dentine OD-41 orange
ECWG6521371ZI-F/ Opaque Dentine OD-37 curry
ECWG6521321ZI-F/ Opaque Dentine OD-32 havanna
ECWG6520901ZI-F/ Correction Powder KM
ECWG6520861ZI-F/ Effect Enamel SO-11 orange
ECWG6520851ZI-F/ Effect Enamel SO-10 blue
ECWG6520831ZI-F/ Effect Enamel PS-3 orange
ECWG6520811ZI-F/ Effect Enamel PS-0 white
ECWG6520801ZI-F/ Transpa TI-5 grey
ECWG6520791ZI-F/ Transpa TI-4 yellow
ECWG6520781ZI-F/ Transpa TI-3 pink
ECWG6520771ZI-F/ Transpa TI-2 white
ECWG6520761ZI-F/ Transpa TI-1 blue
ECWG6520751ZI-F/ Transpa OT opal
ECWG6520741ZI-F/ Transpa NT neutral
ECWG6520731ZI-F/ Clear CL-O
ECWG6520701ZI-F/ Effect Enamel SI-06 heavy orange

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