PANAVIA™ 21

GUDID EKUR001054KA1

ED PRIMER Liquid B

KURARAY NORITAKE DENTAL INC.

Dental composite resin kit

• Primary Device ID: EKUR001054KA1
• NIH Device Record Key: 3141b976-76db-4975-b756-e339e387bc26
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PANAVIA™ 21
• Version Model Number: #1054-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	EKUR001054KA1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012438

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™ 21]

• EKUR001054KA1: ED PRIMER Liquid B
• EKUR001053KA1: ED PRIMER Liquid A
• EKUR000930KA1: DISPENSER
• EKUR000475KA1: OP Paste
• EKUR000470KA1: OP Kit
• EKUR000465KA1: TC Paste
• EKUR000460KA1: TC Kit
• EKUR000455KA1: EX Paste
• EKUR000450KA1: EX Kit
• EKUR000032KA1: OXYGUARD Ⅱ
• EKUR000016KA1: PANAVIA™ ETCHING AGENT V