PANAVIA SA Cement Universal

GUDID EKUR004218KA1

Automix Mixing tip

KURARAY NORITAKE DENTAL INC.

Dental composite resin

• Primary Device ID: EKUR004218KA1
• NIH Device Record Key: 093b3317-c1bb-4130-b071-1dbf676a9c99
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PANAVIA SA Cement Universal
• Version Model Number: #4218-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	EKUR004218KA0 [Unit of Use]
HIBCC	EKUR004218KA1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183537

FDA Product Code

• KLE: Agent, Tooth Bonding, Resin

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-01
• Device Publish Date: 2019-06-21

On-Brand Devices [PANAVIA SA Cement Universal ]

• EKUR004221KA1: Automix Endo tip (SS)
• EKUR004218KA1: Automix Mixing tip
• EKUR004217KA1: Automix Trial (Translucent)
• EKUR004216KA1: Automix Trial (Universal (A2))
• EKUR004214KA1: Automix (Translucent)
• EKUR004213KA1: Automix (White)
• EKUR004212KA1: Automix (Universal (A2))
• EKUR004211KA1: Automix Value Pack (Translucent)
• EKUR004210KA1: Automix Value Pack (Universal (A2))
• EKUR004204KA1: Handmix (Translucent)
• EKUR004203KA1: Handmix (White)
• EKUR004202KA1: Handmix (Universal (A2))