Polishers 2024

GUDID D836TKJGX4

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.

DENT ZAR, INC.

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Primary Device IDD836TKJGX4
NIH Device Record Key98260cb3-a438-4f26-b472-a2110fac8436
Commercial Distribution StatusIn Commercial Distribution
Brand NamePolishers
Version Model Number1
Catalog Number2024
Company DUNS789664455
Company NameDENT ZAR, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD836TKJGX4 [Primary]

FDA Product Code

EJRAgent, Polishing, Abrasive, Oral Cavity

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-03-16
Device Publish Date2022-03-08

Devices Manufactured by DENT ZAR, INC.

D836TKJGX4 - Polishers2022-03-16A 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.
D836TKJGX4 - Polishers2022-03-16 A rotary endpiece designed to be attached to a dental power tool handpiece to produce an abrasive rotation typically for polishi
D836PSLFH9 - LED Curing Light2022-03-15 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 Burs2022-03-15 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 A12018-07-06 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 A22018-07-06 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 A32018-07-06 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 B22018-07-06 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 A42018-07-06 Acorn composite suitable for: Class III, IV, V, as well as, class I and II restorations. Fabrication of extra orally tempered in

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