Ceramill PEEK by JUVORA™ Oyster White

GUDID 05055948229315

CERAMILL PEEK by JUVORA™ 760404, Oyster White 98x20 – 1 unit

JUVORA LIMITED

Dental appliance fabrication material, thermoplastic
Primary Device ID05055948229315
NIH Device Record Key6761f851-79bc-467c-babd-b1b725adceef
Commercial Distribution StatusIn Commercial Distribution
Brand NameCeramill PEEK by JUVORA™ Oyster White
Version Model Number760404
Company DUNS218501322
Company NameJUVORA LIMITED
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+4401253898000
Emailinfo@juvoradental.com

Device Dimensions

Outer Diameter98 Millimeter
Height20 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS105055948229315 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBIResin, Denture, Relining, Repairing, Rebasing

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-02-21
Device Publish Date2019-01-21

On-Brand Devices [Ceramill PEEK by JUVORA™ Oyster White]

05055948229315CERAMILL PEEK by JUVORA™ 760404, Oyster White 98x20 – 1 unit
05055948229308CERAMILL PEEK by JUVORA™ 760403, Oyster White 98x12 – 1 unit
05055948229292CERAMILL PEEK by JUVORA™ 760394, Oyster White 71x20 – 1 unit
05055948229254CERAMILL PEEK by JUVORA™ 760393, Oyster White 71x13 – 1 unit

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