Eagle-Dual-Cured Core Build-Up Material in Auto-Mix Cartridges 1020

GUDID D83610201

Eagle-Dual-Cure Core Build-Up Material Auto-Mix System • Convenient working time in self-cure mode. • Light-cure properties of the material facilitate cure of the product. • Well balanced x-ray opacity permits tooth structure, pins, and posts to be easily distinguishable from material. • Does not require refrigeration; long shelf-life at ambient temperatures. • Significantly saves chair-time due to its auto-mix system. • Intra-oral tips permit application of the material directly into the tooth.

DENT ZAR, INC.

Dental composite resin

• Primary Device ID: D83610201
• NIH Device Record Key: 0d5b9c36-5f3a-45cd-9b6a-71a68791ef5f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eagle-Dual-Cured Core Build-Up Material in Auto-Mix Cartridges
• Version Model Number: 1020
• Catalog Number: 1020
• Company DUNS: 789664455
• Company Name: DENT ZAR, INC.
• Device Count: 3
• 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: 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	D83610200 [Unit of Use]
HIBCC	D83610201 [Primary]

FDA Product Code

• EBF: Material, Tooth Shade, 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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-03

Devices Manufactured by DENT ZAR, INC.

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• D836PSLFH9 - LED Curing Light: 2022-03-15 A mains electricity (AC-powered), hand-held, device intended to be used to activate the polymerization of: 1) a dental resin-bas
• D836QXGZK2 - Dental Diamond Burs: 2022-03-15 Dental burs are a vital tool required for almost every dental treatment and procedure. They are necessary for cutting, grinding,
• D83600080 - Acorn Nano Micro Hybrid-Syringe Shade A1: 2018-07-06 Acorn composite suitable for: Class III, IV, V, as well as, class I and II restorations. Fabrication of extra orally tempered in
• D83600090 - Acorn Nano Micro Hybrid-Syringe Shade A2: 2018-07-06 Acorn composite suitable for: Class III, IV, V, as well as, class I and II restorations. Fabrication of extra orally tempered in
• D83600100 - Acorn Nano Micro Hybrid-Syringe Shade A3: 2018-07-06 Acorn composite suitable for: Class III, IV, V, as well as, class I and II restorations. Fabrication of extra orally tempered in
• D83600110 - Acorn Nano Micro Hybrid-Syringe Shade B2: 2018-07-06 Acorn composite suitable for: Class III, IV, V, as well as, class I and II restorations. Fabrication of extra orally tempered in
• D83600120 - Acorn Nano Micro Hybrid-Syringe Shade A4: 2018-07-06 Acorn composite suitable for: Class III, IV, V, as well as, class I and II restorations. Fabrication of extra orally tempered in