TEETHMATE™ DESENSITIZER

GUDID EKUR001215KA1

Introductory Set

KURARAY NORITAKE DENTAL INC.

Dental coating, tooth-desensitizing Dental coating, tooth-desensitizing Dental coating, tooth-desensitizing Dental coating, tooth-desensitizing Dental coating, tooth-desensitizing Dental coating, tooth-desensitizing Dental coating, tooth-desensitizing Dental coating, tooth-desensitizing Dental coating, tooth-desensitizing

• Primary Device ID: EKUR001215KA1
• NIH Device Record Key: 2d9cb783-ae3a-4c87-ae54-700109ea829a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TEETHMATE™ DESENSITIZER
• Version Model Number: #1215-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	EKUR001215KA1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131068

FDA Product Code

• EJK: Liner, Cavity, Calcium Hydroxide

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: 2019-02-07
• Device Publish Date: 2017-02-17

On-Brand Devices [TEETHMATE™ DESENSITIZER ]

• EKUR001217KA1: LIQUID
• EKUR001216KA1: POWDER
• EKUR001215KA1: Introductory Set
• EKUR001210KA1: Set