CERABIEN™ ZR

GUDID EKUR1041800KA0

LUSTER COMPLETE KIT

KURARAY NORITAKE DENTAL INC.

Dental appliance fabrication material, ceramic

• Primary Device ID: EKUR1041800KA0
• NIH Device Record Key: ac6f981b-52b3-45fb-9e54-d3f602a022a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CERABIEN™ ZR
• Version Model Number: 104-1800KA
• 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	EKUR1041800KA0 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-08
• Device Publish Date: 2019-04-30

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