Visalys Temp A1 USA Normal pack 13780US

GUDID E21713780US1

Visalys Temp A1 Normal pack

Kettenbach GmbH & Co. KG

Dental crown/bridge, temporary
Primary Device IDE21713780US1
NIH Device Record Key54fab8d3-f2d1-43f6-9586-c662e295dca3
Commercial Distribution Discontinuation2017-01-11
Commercial Distribution StatusNot in Commercial Distribution
Brand NameVisalys Temp A1 USA Normal pack
Version Model Number13780US
Catalog Number13780US
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
HIBCCE21713780US1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBGCrown And Bridge, Temporary, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-15

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E217172261 - Mixing Tips2025-08-22 Mixing tips, grey, 50 tips
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E217220111 - Mixing Tips2025-08-15 Mixing tips, red, ø 4.0 mm 8 tips

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