EX-3 PRESS

GUDID EKUR1080531KA0

LnA3 2g×5

KURARAY NORITAKE DENTAL INC.

Dental appliance fabrication material, ceramic
Primary Device IDEKUR1080531KA0
NIH Device Record Key15bbfd9b-5c4e-44e4-b402-38ba4b561e37
Commercial Distribution StatusIn Commercial Distribution
Brand NameEX-3 PRESS
Version Model Number108-0531KA
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
HIBCCEKUR1080531KA0 [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 Date2017-02-17

On-Brand Devices [EX-3 PRESS]

EKUR1260241KA0Paste Opaque Liquid 10ml
EKUR1080952KA0ET0 5g×5
EKUR1080951KA0ET0 5g×5
EKUR1080942KA0EWY 5g×5
EKUR1080941KA0EWY 2g×5
EKUR1080932KA0EW 5g×5
EKUR1080931KA0EW 2g×5
EKUR1080922KA0EW0 5g×5
EKUR1080921KA0EW0 2g×5
EKUR1080912KA0EW00 5g×5
EKUR1080911KA0EW00 2g×5
EKUR1080902KA0HNW0.5 5g×5
EKUR1080901KA0HNW0.5 2g×5
EKUR1080892KA0HNW0 5g×5
EKUR1080891KA0HNW0 2g×5
EKUR1080882KA0HNP2.5 5g×5
EKUR1080881KA0HNP2.5 2g×5
EKUR1080872KA0HNP1.5 5g×5
EKUR1080871KA0HNP1.5 2g×5
EKUR1080862KA0HND4 5g×5
EKUR1080861KA0HND4 2g×5
EKUR1080852KA0HND3 5g×5
EKUR1080851KA0HND3 2g×5
EKUR1080842KA0HND2 5g×5
EKUR1080841KA0HND2 2g×5
EKUR1080832KA0HnC4 5g×5
EKUR1080831KA0HnC4 2g×5
EKUR1080822KA0HnC3 5g×5
EKUR1080821KA0HnC3 2g×5
EKUR1080812KA0HnC2 5g×5
EKUR1080811KA0HnC2 2g×5
EKUR1080802KA0HnC1 5g×5
EKUR1080801KA0HnC1 2g×5
EKUR1080792KA0HnB4 5g×5
EKUR1080791KA0HnB4 2g×5
EKUR1080782KA0HnB3 5g×5
EKUR1080781KA0HnB3 2g×5
EKUR1080772KA0HnB2 5g×5
EKUR1080771KA0HnB2 2g×5
EKUR1080762KA0HnB1 5g×5
EKUR1080761KA0HnB1 2g×5
EKUR1080752KA0HnA4 5g×5
EKUR1080751KA0HnA4 2g×5
EKUR1080742KA0HnA3.5 5g×5
EKUR1080741KA0HnA3.5 2g×5
EKUR1080732KA0HnA3 5g×5
EKUR1080731KA0HnA3 2g×5
EKUR1080722KA0HnA2 5g×5
EKUR1080721KA0HnA2 2g×5
EKUR1080712KA0HnA1 5g×5

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