PANAVIA™ SA Cement Plus Automix

GUDID EKUR003389KA1

Trial（White）

KURARAY NORITAKE DENTAL INC.

Dental composite resin

• Primary Device ID: EKUR003389KA1
• NIH Device Record Key: d044ac6d-25d9-4230-9554-3b37909dbf41
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PANAVIA™ SA Cement Plus Automix
• Version Model Number: #3389-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	EKUR003389KA1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142625

FDA Product Code

• EMA: Cement, Dental

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 [PANAVIA™ SA Cement Plus Automix]

• EKUR003392KA1: Endo tip (SS)
• EKUR003391KA1: Mixing tip
• EKUR003390KA1: Trial（Translucent）
• EKUR003389KA1: Trial（White）
• EKUR003388KA1: Trial（Universal (A2)）
• EKUR003387KA1: Value Pack（Translucent）
• EKUR003385KA1: Value Pack（Universal (A2)）
• EKUR003384KA1: Translucent
• EKUR003383KA1: White
• EKUR003382KA1: Universal (A2)