CERABIEN™

GUDID EKUR1030773KA0

E2 200g

KURARAY NORITAKE DENTAL INC.

Dental appliance fabrication material, ceramic

• Primary Device ID: EKUR1030773KA0
• NIH Device Record Key: 65916b55-3b63-481a-96e1-d185faf6ce70
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CERABIEN™
• Version Model Number: 103-0773KA
• 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	EKUR1030773KA0 [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