Alphaseal Liner 1021

GUDID D83610211

Alphaseal is a visible light cured cavity liner. It has a light paste consistency to facilitate the application. OUTSTANDING FEATURES OF THE PRODUCT: • Fast and easy to apply • Economical • Compatible with all restoratives and cements • Mechanically strong and insoluble in oral fluids • Long shelf-life; no refrigeration required • Resistant to etching agents • X-ray opaque • Simplified handling; direct to tooth application

DENT ZAR, INC.

Calcium hydroxide dental cement Calcium hydroxide dental cement

• Primary Device ID: D83610211
• NIH Device Record Key: dcf583a2-dffd-40c5-84b5-9663d50ccbbe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alphaseal Liner
• Version Model Number: 1021
• Catalog Number: 1021
• Company DUNS: 789664455
• Company Name: DENT ZAR, INC.
• Device Count: 4
• 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	D83610210 [Unit of Use]
HIBCC	D83610211 [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: 2016-09-04

Devices Manufactured by DENT ZAR, INC.

• D836TKJGX4 - Polishers: 2022-03-16 A rotary endpiece designed to be attached to a dental power tool handpiece to produce an abrasive rotation typically for polishi
• 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