Max Bond LC Agent A

GUDID 18522530060198

Agent A for Max Bond LC Bonding Agent

J. MORITA U.S.A., INC

Dentine bonding agent/set

• Primary Device ID: 18522530060198
• NIH Device Record Key: d142d184-4b06-45b3-b7c2-10b3a2c21595
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Max Bond LC Agent A
• Version Model Number: 28200200
• Company DUNS: 021866033
• Company Name: J. MORITA U.S.A., 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: 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
GS1	18522530060198 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060882

FDA Product Code

• KLE: Agent, Tooth Bonding, Resin

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: 2016-09-22

On-Brand Devices [Max Bond LC Agent A]

• 18522530060198: Agent A for Max Bond LC Bonding Agent
• 10852253006196: Agent A for Max Bond LC Bonding Agent