SCREENING PORCELAIN

GUDID EKUR1060141KA0

GM ORANGE 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: EKUR1060141KA0
• NIH Device Record Key: ff9d6581-7cd6-478a-9054-f49005c19798
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SCREENING PORCELAIN
• Version Model Number: 106-0141KA
• 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	EKUR1060141KA0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K884356

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 [SCREENING PORCELAIN]

• EKUR1060201KA0: SR GRAY 10g
• EKUR1060191KA0: S BROWN 10g
• EKUR1060181KA0: MR GLAY 10g
• EKUR1060171KA0: M BROWN 10g
• EKUR1060161KA0: GIL 10g
• EKUR1060151KA0: GM WHITE 10g
• EKUR1060141KA0: GM ORANGE 10g
• EKUR1060131KA0: NW0.5G 10g
• EKUR1060121KA0: NW0G 10g
• EKUR1060111KA0: D3G 10g
• EKUR1060101KA0: D2G 10g
• EKUR1060091KA0: C2G 10g
• EKUR1060081KA0: C1G 10g
• EKUR1060071KA0: B3G 10g
• EKUR1060061KA0: B2G 10g
• EKUR1060051KA0: B1G 10g
• EKUR1060041KA0: A3G 10g
• EKUR1060031KA0: A2G 10g
• EKUR1060021KA0: A1G 10g
• EKUR1060010KA0: SCREENING PORCELAIN KIT 170g