Noritake Super Porcelain Ti-22

GUDID EKUR1050731KA0

CV-3 10g

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: EKUR1050731KA0
• NIH Device Record Key: 352dbbe7-9c31-4a9f-817d-6b7618336733
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Noritake Super Porcelain Ti-22
• Version Model Number: 105-0731KA
• 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	EKUR1050731KA0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K992024

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 [Noritake Super Porcelain Ti-22]

• EKUR1051161KA0: AD-T 10g
• EKUR1051151KA0: AD-B 10g
• EKUR1051149KA0: Stain GLAZE 5g
• EKUR1050961KA0: LIGHT TISSUE 10g
• EKUR1050951KA0: DARK TISSUE 10g
• EKUR1050941KA0: CORAL PINK 10g
• EKUR1050931KA0: BROWN 10g
• EKUR1050921KA0: PINK 10g
• EKUR1050911KA0: ORANGE 10g
• EKUR1050901KA0: LIGHT ORANGE 10g
• EKUR1050891KA0: GREEN 10g
• EKUR1050881KA0: BLUE 10g
• EKUR1050871KA0: YELLOW 10g
• EKUR1050861KA0: GRAY 10g
• EKUR1050851KA0: WHITE 10g
• EKUR1050841KA0: CREAMY WHITE 10g
• EKUR1050831KA0: INCISAL AUREOLA 10g
• EKUR1050821KA0: CREAMY ENAMEL 10g
• EKUR1050811KA0: SUN BRIGHT 10g
• EKUR1050801KA0: T Blue 10g
• EKUR1050791KA0: LT1 10g
• EKUR1050781KA0: LT0 10g
• EKUR1050771KA0: T2 10g
• EKUR1050761KA0: T1 10g
• EKUR1050751KA0: T0 10g
• EKUR1050741KA0: CV-4 10g
• EKUR1050731KA0: CV-3 10g
• EKUR1050721KA0: CV-2 10g
• EKUR1050711KA0: CV-1 10g
• EKUR1050701KA0: E3 10g
• EKUR1050691KA0: E2 10g
• EKUR1050681KA0: E1 10g
• EKUR1050671KA0: D4B 10g
• EKUR1050661KA0: D3B 10g
• EKUR1050651KA0: D2B 10g
• EKUR1050641KA0: C4B 10g
• EKUR1050631KA0: C3B 10g
• EKUR1050621KA0: C2B 10g
• EKUR1050611KA0: C1B 10g
• EKUR1050601KA0: B4B 10g
• EKUR1050591KA0: B3B 10g
• EKUR1050581KA0: B2B 10g
• EKUR1050571KA0: B1B 10g
• EKUR1050561KA0: A4B 10g
• EKUR1050551KA0: A3.5B 10g
• EKUR1050541KA0: A3B 10g
• EKUR1050531KA0: A2B 10g
• EKUR1050521KA0: A1B 10g
• EKUR1050511KA0: M-BROWN 10g
• EKUR1050501KA0: M-CERVICAL 10g