CERABIEN™ ZR

GUDID EKUR1045651KA0

FC PASTE STAIN GREEN1 3g

KURARAY NORITAKE DENTAL INC.

Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic

• Primary Device ID: EKUR1045651KA0
• NIH Device Record Key: c13dbb08-a0de-405f-812a-843ea48f3bb7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CERABIEN™ ZR
• Version Model Number: 104-5651KA
• 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	EKUR1045651KA0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170834

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: 2017-11-30

On-Brand Devices [CERABIEN™ ZR]

• EKUR1045923KA0: LT Coral 200g
• EKUR1045922KA0: LT Coral 50g
• EKUR1045921KA0: LT Coral 10g
• EKUR1045913KA0: LT Royal Blue 200g
• EKUR1045912KA0: LT Royal Blue 50g
• EKUR1045911KA0: LT Royal Blue 10g
• EKUR1045903KA0: LT Super Luster 200g
• EKUR1045902KA0: LT Super Luster 50g
• EKUR1045901KA0: LT Super Luster 10g
• EKUR1045893KA0: LTx 200g
• EKUR1045892KA0: LTx 50g
• EKUR1045891KA0: LTx 10g
• EKUR1045883KA0: T Clear 200g
• EKUR1045882KA0: T Clear 50g
• EKUR1045881KA0: T Clear 10g
• EKUR1041800KA0: LUSTER COMPLETE KIT
• EKUR1041780KA0: ENAMEL / TRANSLUCENT COMPLETE KIT
• EKUR1260152KA0: Forming Liquid 100ml
• EKUR1260122KA0: IS Liquid 100ml
• EKUR1260111KA0: IS Liquid 10ml
• EKUR1045870KA0: FC PASTE STAIN BASIC KIT 26g
• EKUR1045861KA0: FC PASTE STAIN CLR GLAZE 5g
• EKUR1045851KA0: FC PASTE STAIN GLAZE 5g
• EKUR1045841KA0: FC PASTE STAIN FLUORO 3g
• EKUR1045831KA0: FC PASTE STAIN VALUE 3g
• EKUR1045821KA0: FC PASTE STAIN WHITE 3g
• EKUR1045811KA0: FC PASTE STAIN D+ 3g
• EKUR1045801KA0: FC PASTE STAIN C+ 3g
• EKUR1045791KA0: FC PASTE STAIN B+ 3g
• EKUR1045781KA0: FC PASTE STAIN A+ 3g
• EKUR1045771KA0: FC PASTE STAIN RED 3g
• EKUR1045761KA0: FC PASTE STAIN PINK 3g
• EKUR1045751KA0: FC PASTE STAIN SALMON PINK 3g
• EKUR1045741KA0: FC PASTE STAIN REDDISH BROWN 3g
• EKUR1045731KA0: FC PASTE STAIN EARTH BROWN 3g
• EKUR1045721KA0: FC PASTE STAIN CERVICAL3 3g
• EKUR1045711KA0: FC PASTE STAIN CERVICAL2 3g
• EKUR1045701KA0: FC PASTE STAIN CERVICAL1 3g
• EKUR1045691KA0: FC PASTE STAIN MAMELON ORANGE2 3g
• EKUR1045681KA0: FC PASTE STAIN MAMELON ORANGE1 3g
• EKUR1045671KA0: FC PASTE STAIN YELLOW 3g
• EKUR1045661KA0: FC PASTE STAIN GREEN2 3g
• EKUR1045651KA0: FC PASTE STAIN GREEN1 3g
• EKUR1045641KA0: FC PASTE STAIN BLUE 3g
• EKUR1045631KA0: FC PASTE STAIN GRAYISH BLUE 3g
• EKUR1045621KA0: FC PASTE STAIN DARK GRAY 3g
• EKUR1045611KA0: FC PASTE STAIN LIGHT GRAY
• EKUR1045601KA0: FC PASTE STAIN BLACK 3g
• EKUR1045590KA0: FC PASTE STAIN KIT 85g
• EKUR1045581KA0: External Stain VC Glaze 10g