PANAVIA SA Cement Universal

GUDID EKUR004202KA1

Handmix (Universal (A2))

KURARAY NORITAKE DENTAL INC.

Dental composite resin
Primary Device IDEKUR004202KA1
NIH Device Record Keyd8543d94-1e33-4ebf-9f41-8c3d6bb472ce
Commercial Distribution StatusIn Commercial Distribution
Brand NamePANAVIA SA Cement Universal
Version Model Number#4202-KA
Company DUNS697119498
Company NameKURARAY NORITAKE DENTAL INC.
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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEKUR004202KA1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EMACement, Dental

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-06-26
Device Publish Date2019-06-18

On-Brand Devices [PANAVIA SA Cement Universal ]

EKUR004221KA1Automix Endo tip (SS)
EKUR004218KA1Automix Mixing tip
EKUR004217KA1Automix Trial (Translucent)
EKUR004216KA1Automix Trial (Universal (A2))
EKUR004214KA1Automix (Translucent)
EKUR004213KA1Automix (White)
EKUR004212KA1Automix (Universal (A2))
EKUR004211KA1Automix Value Pack (Translucent)
EKUR004210KA1Automix Value Pack (Universal (A2))
EKUR004204KA1Handmix (Translucent)
EKUR004203KA1Handmix (White)
EKUR004202KA1Handmix (Universal (A2))

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