Kera Ti5-Disc 98,5 x 22 mm

GUDID EDWAT100452221

Ti6Al4V based dental alloy for milling, grade 5, Dimension: 98,5 mm x 22 mm

Eisenbacher Dentalwaren ED GmbH

Dental casting non-noble alloy
Primary Device IDEDWAT100452221
NIH Device Record Key95013f48-043a-48fa-8f48-3a2b21c15301
Commercial Distribution StatusIn Commercial Distribution
Brand NameKera Ti5-Disc 98,5 x 22 mm
Version Model NumberT10045222
Company DUNS344231006
Company NameEisenbacher Dentalwaren ED GmbH
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEDWAT100452221 [Primary]

FDA Product Code

EJHAlloy, Metal, Base

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-14
Device Publish Date2020-02-06

Devices Manufactured by Eisenbacher Dentalwaren ED GmbH

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EDWA130412161 - Kera®Soft-Disc 98,0 x 16 mm2023-07-03 Non-precious-metal dental milling alloy on cobalt-base, type 4; Dimension: 98,0 mm x 16 mm
EDWA130412201 - Kera®Soft-Disc 98,0 x 20 mm2023-07-03 Non-precious-metal dental milling alloy on cobalt-base, type 4; Dimension: 98,0 mm x 20 mm
EDWA131412181 - Kera®Soft-Disc 98,0 x 18 mm2023-07-03 Non-precious-metal dental milling alloy on cobalt-base, type 4; Dimension: 98,0 mm x 18 mm
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