EX-3 PRESS LF

GUDID EKUR1080992KA0

nA3.5B 50g

KURARAY NORITAKE DENTAL INC.

Dental appliance fabrication material, ceramic
Primary Device IDEKUR1080992KA0
NIH Device Record Keybf677e2f-1860-4f5d-94a7-3cd3275aa538
Commercial Distribution StatusIn Commercial Distribution
Brand NameEX-3 PRESS LF
Version Model Number108-0992KA
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
HIBCCEKUR1080992KA0 [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 LF]

EKUR1082011KA0MRP 10g
EKUR1081991KA0Internal Stain Bright 3g
EKUR1081981KA0Internal Stain Fluoro 3g
EKUR1081971KA0Internal Stain D+ 3g
EKUR1081961KA0Internal Stain C+ 3g
EKUR1081951KA0Internal Stain B+ 3g
EKUR1081941KA0Internal Stain A+ 3g
EKUR1081931KA0Internal Stain Salmon Pink 3g
EKUR1081921KA0Internal Stain Red 3g
EKUR1081911KA0Internal Stain Reddish Brown 3g
EKUR1081901KA0Internal Stain Earth Brown 3g
EKUR1081891KA0Internal Stain Cervical 3 3g
EKUR1081881KA0Internal Stain Cervical 2 3g
EKUR1081871KA0Internal Stain Cervical 1 3g
EKUR1081861KA0Internal Stain Mamelon Orange 2 3g
EKUR1081851KA0Internal Stain Mamelon Orange 1 3g
EKUR1081841KA0Internal Stain Incisal Blue 2 3g
EKUR1081831KA0Internal Stain Incisal Blue 1 3g
EKUR1081821KA0Internal Stain Gray 3g
EKUR1081811KA0Internal Stain White 3g
EKUR1081804KA0External Stain Glaze 30g
EKUR1081801KA0External Stain Glaze 10g
EKUR1081791KA0External Stain D+ 3g
EKUR1081781KA0External Stain C+ 3g
EKUR1081771KA0External Stain B+ 3g
EKUR1081761KA0External Stain A+ 3g
EKUR1081751KA0External Stain Red 3g
EKUR1081741KA0External Stain Pink 3g
EKUR1081731KA0External Stain Salmon Pink 3g
EKUR1081721KA0External Stain Reddish Brown 3g
EKUR1081711KA0External Stain Earth Brown 3g
EKUR1081701KA0External Stain Cervical 3 3g
EKUR1081691KA0External Stain Cervical 2 3g
EKUR1081681KA0External Stain Cervical 1 3g
EKUR1081671KA0External Stain Yellow 3g
EKUR1081661KA0External Stain Orange 2 3g
EKUR1081651KA0External Stain Orange 1 3g
EKUR1081641KA0External Stain Green 2 3g
EKUR1081631KA0External Stain Green 1 3g
EKUR1081621KA0External Stain Blue 3g
EKUR1081611KA0External Stain Black 3g
EKUR1081601KA0External Stain Pure White 3g
EKUR1081591KA0External Stain Gray 3g
EKUR1081582KA0AD-T 50g
EKUR1081581KA0AD-T 10g
EKUR1081572KA0AD-B 50g
EKUR1081571KA0AD-B 10g
EKUR1081562KA0Tissue 7 50g
EKUR1081561KA0Tissue 7 10g
EKUR1081552KA0Tissue 6 50g

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