Bonding Agent (Self-Cure) Part A & Part B 1018

GUDID D83610181

• Simple and fast application technique. • Compatible with all light-cured, and self-cured restorative materials and cements. • Long shelf-life with no need for refrigeration. • Economical. • No pulp irritation.

DENT ZAR, INC.

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• Primary Device ID: D83610181
• NIH Device Record Key: d4ac9435-27bf-4f64-9c91-a8acc9a57042
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bonding Agent (Self-Cure) Part A & Part B
• Version Model Number: 1018
• Catalog Number: 1018
• Company DUNS: 789664455
• Company Name: DENT ZAR, 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D83610181 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012794

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: 2016-09-03

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