CLEARFIL MAJESTY™ ES-2

GUDID EKUR003117KA1

PLT (B2)

KURARAY NORITAKE DENTAL INC.

Dental composite resin

• Primary Device ID: EKUR003117KA1
• NIH Device Record Key: bf610d2c-1020-4b2b-9247-f9b3b2bc9dcc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CLEARFIL MAJESTY™ ES-2
• Version Model Number: #3117-KA
• Company DUNS: 697119498
• Company Name: KURARAY NORITAKE DENTAL INC.
• Device Count: 20
• 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: true
• 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	EKUR003117KA0 [Unit of Use]
HIBCC	EKUR003117KA1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121583

FDA Product Code

• EBF: Material, Tooth Shade, Resin

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-02-17

On-Brand Devices [CLEARFIL MAJESTY™ ES-2]

• EKUR003157KA1: PLT (Gray)
• EKUR003156KA1: PLT (Blue)
• EKUR003155KA1: PLT (Amber)
• EKUR003154KA1: PLT (Clear)
• EKUR003153KA1: PLT (WD)
• EKUR003152KA1: PLT (XWD)
• EKUR003151KA1: PLT (A4D)
• EKUR003150KA1: PLT (A3.5D)
• EKUR003149KA1: PLT (A3D)
• EKUR003148KA1: PLT (A2D)
• EKUR003147KA1: PLT (A1D)
• EKUR003146KA1: PLT (WE)
• EKUR003145KA1: PLT (XWE)
• EKUR003144KA1: PLT (A4E)
• EKUR003143KA1: PLT (A3.5E)
• EKUR003142KA1: PLT (A3E)
• EKUR003141KA1: PLT (A2E)
• EKUR003140KA1: PLT (A1E)
• EKUR003127KA1: PLT (W)
• EKUR003126KA1: PLT (XW)
• EKUR003125KA1: PLT (D3)
• EKUR003124KA1: PLT (D2)
• EKUR003123KA1: PLT (C4)
• EKUR003122KA1: PLT (C3)
• EKUR003121KA1: PLT (C2)
• EKUR003120KA1: PLT (C1)
• EKUR003119KA1: PLT (B4)
• EKUR003118KA1: PLT (B3)
• EKUR003117KA1: PLT (B2)
• EKUR003116KA1: PLT (B1)
• EKUR003115KA1: PLT (KA6)
• EKUR003114KA1: PLT (A4)
• EKUR003113KA1: PLT (A3.5)
• EKUR003112KA1: PLT (A3)
• EKUR003111KA1: PLT (A2)
• EKUR003110KA1: PLT (A1)
• EKUR003106KA1: PLT Trial (A2)
• EKUR003105KA1: PLT Premium Trial
• EKUR003101KA1: PLT Premium Starter Kit
• EKUR003100KA1: PLT Professional Kit
• EKUR003067KA1: Syringe (Gray)
• EKUR003066KA1: Syringe (Blue)
• EKUR003065KA1: Syringe (Amber)
• EKUR003064KA1: Syringe (Clear)
• EKUR003063KA1: Syringe (WD)
• EKUR003062KA1: Syringe (XWD)
• EKUR003061KA1: Syringe (A4D)
• EKUR003060KA1: Syringe (A3.5D)
• EKUR003059KA1: Syringe (A3D)
• EKUR003058KA1: Syringe (A2D)