K-ETCHANT Syringe

GUDID EKUR003253KA1

Needle tips (E)

KURARAY NORITAKE DENTAL INC.

Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution

• Primary Device ID: EKUR003253KA1
• NIH Device Record Key: 8cd20d76-435a-49e9-a69a-e4cd1e61bc45
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: K-ETCHANT Syringe
• Version Model Number: #3253-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	EKUR003253KA0 [Unit of Use]
HIBCC	EKUR003253KA1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133078

FDA Product Code

• KLE: Agent, Tooth Bonding, 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 [K-ETCHANT Syringe]

• EKUR003253KA1: Needle tips (E)