TEETHMATE™ F-1

GUDID EKUR001765KA1

Natural

KURARAY NORITAKE DENTAL INC.

Dental composite resin

• Primary Device ID: EKUR001765KA1
• NIH Device Record Key: d9c2a78c-d45b-4025-a5c9-39fd594b1580
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TEETHMATE™ F-1
• Version Model Number: #1765-KA
• 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	EKUR001765KA1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012742

FDA Product Code

• EBC: Sealant, Pit And Fissure, And Conditioner

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 [TEETHMATE™ F-1]

• EKUR001795KA1: Opaque
• EKUR001790KA1: Kit (Opaque)
• EKUR001765KA1: Natural
• EKUR001760KA1: Kit (Natural)