LED Curing Light 2023

GUDID D836PSLFH9

A mains electricity (AC-powered), hand-held, device intended to be used to activate the polymerization of: 1) a dental resin-based material in the oral cavity; and/or 2) a surgical adhesive/sealant during an open-surgery procedure. It typically includes a light source [e.g., halogen, fluorescent, light-emitting diode (LED)] that emits light in the visible, or less frequently, ultraviolet spectrum, mounted in a handpiece that is typically attached to or used with a portable control unit or charging station.

DENT ZAR, INC.

Dental/surgical polymerization lamp

• Primary Device ID: D836PSLFH9
• NIH Device Record Key: ef86d2b0-527c-46dd-af83-09d22c74d3df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LED Curing Light
• Version Model Number: 1
• Catalog Number: 2023
• Company DUNS: 789664455
• Company Name: DENT ZAR, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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	D836PSLFH9 [Primary]

FDA Product Code

• EAY: Light, Fiber Optic, Dental

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-03-15
• Device Publish Date: 2022-03-07

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: 2022-03-15A mains electricity (AC-powered), hand-held, device intended to be used to activate the polymerization of: 1) a dental resin-based material in the oral cavity; and/or 2) a surgical adhesive/sealant during an open-surgery procedure. It typically includes a light source [e.g., halogen, fluorescent, light-emitting diode (LED)] that emits light in the visible, or less frequently, ultraviolet spectrum, mounted in a handpiece that is typically attached to or used with a portable control unit or charging station.
• 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