PANAVIA™ V5

GUDID EKUR003630KA1

Try-in Paste (Soft White (B0.5))

KURARAY NORITAKE DENTAL INC.

Dental composite resin kit

• Primary Device ID: EKUR003630KA1
• NIH Device Record Key: 45ad3c2d-28ce-4caa-915c-52321c45da72
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PANAVIA™ V5
• Version Model Number: #3630-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	EKUR003630KA1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150704

FDA Product Code

• EMA: Cement, Dental

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: 2023-06-08
• Device Publish Date: 2023-05-31

On-Brand Devices [PANAVIA™ V5]

• EKUR003635KA1: Tooth Primer
• EKUR003629KA1: Endo tip (S)
• EKUR003626KA1: Mixing tip
• EKUR003625KA1: Try-in Paste (Opaque)
• EKUR003624KA1: Try-in Paste (White)
• EKUR003623KA1: Try-in Paste (Brown (A4))
• EKUR003622KA1: Try-in Paste (Clear)
• EKUR003621KA1: Try-in Paste (Universal (A2))
• EKUR003615KA1: Paste (Opaque)
• EKUR003614KA1: Paste (White)
• EKUR003613KA1: Paste (Brown (A4))
• EKUR003612KA1: Paste (Clear)
• EKUR003611KA1: Paste (Universal (A2))
• EKUR003608KA1: Sample Pack (Universal(A2))
• EKUR003605KA1: Introductory Kit (Clear)
• EKUR003604KA1: Introductory Kit (Universal (A2))
• EKUR003602KA1: Standard Kit (Clear)
• EKUR003601KA1: Standard Kit (Universal (A2))
• EKUR003630KA1: Try-in Paste (Soft White (B0.5))