Noritake Super Porcelain Ti-22

GUDID EKUR1050641KA0

C4B 10g

KURARAY NORITAKE DENTAL INC.

Dental appliance fabrication material, ceramic

• Primary Device ID: EKUR1050641KA0
• NIH Device Record Key: 464caea9-fff6-4bad-a3cf-e0119498e862
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Noritake Super Porcelain Ti-22
• Version Model Number: 105-0641KA
• 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	EKUR1050641KA0 [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