K-ETCHANT Syringe

GUDID EKUR003253KA1

Needle tips (E)

KURARAY NORITAKE DENTAL INC.

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)