Esthetic Colorant

GUDID EKUR1270165KA0

OPAQUE 12ML

KURARAY NORITAKE DENTAL INC.

Dental appliance fabrication material, ceramic

• Primary Device ID: EKUR1270165KA0
• NIH Device Record Key: dc968c77-55d0-4d6a-9ba0-764a58a6ab70
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Esthetic Colorant
• Version Model Number: 127-0165KA
• 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	EKUR1270165KA0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220369

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: 2022-11-08
• Device Publish Date: 2022-10-31

On-Brand Devices [Esthetic Colorant]

• EKUR2270019KA0: LIQUID BRUSH PEN
• EKUR1270165KA0: OPAQUE 12ML
• EKUR1270155KA0: WHITE 12ML
• EKUR1270145KA0: PINK 12ML
• EKUR1270135KA0: VIOLET 12ML
• EKUR1270125KA0: BLUE 12ML
• EKUR1270115KA0: GRAY 12ML
• EKUR1270105KA0: ORANGE 12ML
• EKUR1270095KA0: BROWN 12ML
• EKUR1270085KA0: D PLUS 12ML
• EKUR1270075KA0: C PLUS 12ML
• EKUR1270065KA0: B PLUS 12ML
• EKUR1270055KA0: A PLUS 12ML
• EKUR1270010KA0: BASIC KIT 144ML