CERABIEN™

GUDID EKUR1030193KA0

SBA4 200g

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: EKUR1030193KA0
• NIH Device Record Key: 8778362c-a3cd-4210-8286-3a3bc2d514ad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CERABIEN™
• Version Model Number: 103-0193KA
• 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	EKUR1030193KA0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K992023

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 [CERABIEN™]

• EKUR1031722KA0: AD-T 50g
• EKUR1031712KA0: AD-B 50g
• EKUR1031701KA0: AD-T 10g
• EKUR1031691KA0: AD-B 10g
• EKUR1031681KA0: Internal Stain Bright 3g
• EKUR1031671KA0: Internal Stain D+ 3g
• EKUR1031661KA0: Internal Stain C+ 3g
• EKUR1031651KA0: Internal Stain B+ 3g
• EKUR1031641KA0: Internal Stain A+ 3g
• EKUR1031631KA0: Internal Stain Salmon Pink 3g
• EKUR1031621KA0: Internal Stain Red 3g
• EKUR1031611KA0: Internal Stain Reddish Brown 3g
• EKUR1031601KA0: Internal Stain Earth Brown 3g
• EKUR1031591KA0: Internal Stain Cervical3 3g
• EKUR1031581KA0: Internal Stain Cervical2 3g
• EKUR1031571KA0: Internal Stain Cervical1 3g
• EKUR1031561KA0: Internal Stain Mamelon Orange2 3g
• EKUR1031551KA0: Internal Stain Mamelon Orange1 3g
• EKUR1031541KA0: Internal Stain Incisal Blue2 3g
• EKUR1031531KA0: Internal Stain Incisal Blue1 3g
• EKUR1031521KA0: Internal Stain White 3g
• EKUR1031511KA0: External Stain Glaze 10g
• EKUR1031501KA0: External Stain D+ 3g
• EKUR1031491KA0: External Stain C+ 3g
• EKUR1031481KA0: External Stain B+ 3g
• EKUR1031471KA0: External Stain A+ 3g
• EKUR1031461KA0: External Stain Red 3g
• EKUR1031451KA0: External Stain Pink 3g
• EKUR1031441KA0: External Stain Salmon Pink 3g
• EKUR1031431KA0: External Stain Reddish Brown 3g
• EKUR1031421KA0: External Stain Earth Brown 3g
• EKUR1031411KA0: External Stain Cervical3 3g
• EKUR1031401KA0: External Stain Cervical2 3g
• EKUR1031391KA0: External Stain Cervical1 3g
• EKUR1031381KA0: External Stain Yellow 3g
• EKUR1031371KA0: External Stain Orange-2 3g
• EKUR1031361KA0: External Stain Orange-1 3g
• EKUR1031351KA0: External Stain Green-2 3g
• EKUR1031341KA0: External Stain Green-1 3g
• EKUR1031331KA0: External Stain Blue 3g
• EKUR1031321KA0: External Stain Black 3g
• EKUR1031311KA0: External Stain Pure White 3g
• EKUR1031301KA0: External Stain Gray 3g
• EKUR1031292KA0: LIGHT TISSUE 50g
• EKUR1031291KA0: LIGHT TISSUE 10g
• EKUR1031282KA0: DARK TISSUE 50g
• EKUR1031281KA0: DARK TISSUE 10g
• EKUR1031272KA0: MAMELON-2 50g
• EKUR1031271KA0: MAMELON-2 10g
• EKUR1031262KA0: MAMELON-1 50g