PANAVIA™ SA Cement Plus Handmix

GUDID EKUR003357KA1

Trial (Universal(A2))

KURARAY NORITAKE DENTAL INC.

Dental composite resin

• Primary Device ID: EKUR003357KA1
• NIH Device Record Key: 0bccb24f-7b7f-4868-ac37-3c67b8a0b874
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PANAVIA™ SA Cement Plus Handmix
• Version Model Number: #3357-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	EKUR003357KA1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142623

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 Handmix]

• EKUR003359KA1: Trial (Translucent)
• EKUR003357KA1: Trial (Universal(A2))
• EKUR003356KA1: Double Pack (Translucent)
• EKUR003355KA1: Double Pack (Universal(A2))
• EKUR003354KA1: (Translucent)
• EKUR003353KA1: (White)
• EKUR003352KA1: (Universal(A2))