DENT ZAR, INC.

Address:22156 Sherman Way, Unit B,Canoga Park,CA,91303,US

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Device Description : Orion is a light-cure core build-up material. It has, virtually, unlimited worki Orion is a light-cure core build-up material. It has, virtually, unlimited working time. Material is easy to carve and contour, due to it, moderately hard filler. It is moldable, non-sticky yet adhesive consistency. Material has long shelf life at ambient temperatures and its X-ray opaque.

Device Class :

Duns Number: 789664455

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 5

Device Description : Eagle-Dual-Cure Core Build-Up Material Auto-Mix System• Convenient working time 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.

Device Class :

Duns Number: 789664455

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 3

- Catalog Number : 1021

Device Description : Alphaseal is a visible light cured cavity liner. It has a light paste consistenc 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

Device Class :

Duns Number: 789664455

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 4

- Catalog Number : 2023

Device Description : A mains electricity (AC-powered), hand-held, device intended to be used to activ 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.

Device Class : 1

Duns Number: 789664455

Premarket Exempt : Yes

Product Code : EAY

Prescription Use : Yes

Device Count : 1

- Catalog Number : 2022

Device Description : Dental burs are a vital tool required for almost every dental treatment and proc Dental burs are a vital tool required for almost every dental treatment and procedure. They are necessary for cutting, grinding, and removing hard and soft tissue and are designed to attach to the rotary dental handpiece for fast and efficient dental work.

Device Class : 1

Duns Number: 789664455

Premarket Exempt : Yes

Product Code : DZP

Prescription Use : Yes

Device Count : 1

- Catalog Number : 2024

Device Description : A rotary endpiece designed to be attached to a dental power tool handpiece to pr A rotary endpiece designed to be attached to a dental power tool handpiece to produce an abrasive rotation typically for polishing and smoothing natural or restorative dental materials (e.g., crown) during a dental procedure. Also referred to as a polisher, it is available in various forms (e.g., conical), sizes, and materials [e.g., silicone, rubber, metal, diamond, silicon carbide, aluminium oxide]. This is a reusable device.

Device Class : 1

Duns Number: 789664455

Premarket Exempt : Yes

Product Code : EJR

Prescription Use : No

Device Count : 1