Noritake Super Porcelain EX-3

GUDID EKUR1023091KA0

Aqua Blue1 10g

KURARAY NORITAKE DENTAL INC.

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• Primary Device ID: EKUR1023091KA0
• NIH Device Record Key: ed02f70d-eba3-4f8b-95a7-030cdfc8c5a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Noritake Super Porcelain EX-3
• Version Model Number: 102-3091KA
• Company DUNS: 697119498
• Company Name: KURARAY NORITAKE DENTAL INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EKUR1023091KA0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193060
• Premarket Notification: K884356

FDA Product Code

• EIH: Powder, Porcelain

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-24
• Device Publish Date: 2017-02-17

On-Brand Devices [Noritake Super Porcelain EX-3]

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• EKUR1024582KA0: LT Coral 50g
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• EKUR1024573KA0: LT Royal Blue 200g
• EKUR1024572KA0: LT Royal Blue 50g
• EKUR1024571KA0: LT Royal Blue 10g
• EKUR1024563KA0: LT Super Luster 200g
• EKUR1024562KA0: LT Super Luster 50g
• EKUR1024561KA0: LT Super Luster 10g
• EKUR1024553KA0: LTx 200g
• EKUR1024552KA0: LTx 50g
• EKUR1024551KA0: LTx 10g
• EKUR1024543KA0: T Clear 200g
• EKUR1024542KA0: T Clear 50g
• EKUR1024541KA0: T Clear 10g
• EKUR1020190KA0: LUSTER COMPLETE KIT
• EKUR1020170KA0: ENAMEL / TRANSLUCENT COMPLETE KIT
• EKUR1020010KA0: FULL KIT 620g
• EKUR1020692KA0: PONP1.5 6g
• EKUR1020682KA0: POEW 6g
• EKUR1020672KA0: POEW0 6g
• EKUR1020662KA0: POnD4 6g
• EKUR1020652KA0: POnD3 6g
• EKUR1020642KA0: POnD2 6g
• EKUR1020632KA0: POnC4 6g
• EKUR1020622KA0: POnC3 6g
• EKUR1020612KA0: POnC2 6g
• EKUR1020602KA0: POnC1 6g
• EKUR1020592KA0: POnB4 6g
• EKUR1020582KA0: POnB3 6g
• EKUR1020572KA0: POnB2 6g
• EKUR1020562KA0: POnB1 6g
• EKUR1020552KA0: POnA4 6g
• EKUR1020542KA0: POnA3.5 6g
• EKUR1020532KA0: POnA3 6g
• EKUR1020522KA0: POnA2 6g
• EKUR1020512KA0: POnA1 6g
• EKUR1020502KA0: POD4 6g
• EKUR1020492KA0: POD3 6g
• EKUR1020482KA0: POD2 6g
• EKUR1020472KA0: POC4 6g
• EKUR1020462KA0: POC3 6g
• EKUR1020452KA0: POC2 6g
• EKUR1020442KA0: POC1 6g
• EKUR1020432KA0: POB4 6g
• EKUR1020422KA0: POB3 6g
• EKUR1020412KA0: POB2 6g
• EKUR1020402KA0: POB1 6g
• EKUR1020392KA0: POA4 6g
• EKUR1020382KA0: POA3.5 6g