Home GUDID E226100105738 KOMET Root Canal Files
Primary DI E226100105738
Brand KOMET Root Canal Files
Company Gebr. Brasseler GmbH & Co. KG
Model PRQ4L21.204.045.G1
Catalog number PRQ4L21.204.045
Published 2023-02-01
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name EKS FILE, PULP CANAL, ENDODONTIC
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class EKS File, Pulp Canal, Endodontic Dental 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status E226100105731 Primary HIBCC 0 E226100105738 Unit of Use HIBCC 0
GMDN Terms# Term, Definition table Term Definition Rotary/reciprocating endodontic file/rasp, single-use A dental endpiece designed to be attached to a rotary or reciprocating dental power tool handpiece to debride and enlarge the root canal and smooth its walls by cutting or abrasion. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and its working end has a polygonal cross-section with edges. It may also be referred to as a rotary or engine file, or reamer. This is a single-use device.
Regulatory Flags# DUNS number 317409001 Device count 6 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 14053613286364 Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II 05.005.431S 05.005.431S 2026-10-01 14053613286395 Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II 05.005.433S 05.005.433S 2026-10-01 14053613286425 Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II 05.005.442S 05.005.442S 2026-10-01 14053613286449 Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II 05.005.451S 05.005.451S 2026-10-01 14053613286456 Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II 05.005.452S 05.005.452S 2026-10-01 14053613286470 Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II 05.005.453S 05.005.453S 2026-10-01 14053613286487 Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II 05.005.454S 05.005.454S 2026-10-01 14053613286494 Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II 05.005.445S 05.005.445S 2026-10-01 14053613286722 Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II 05.005.305S 05.005.305S 2026-10-01 14053613286777 Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II 05.005.005S 05.005.005S 2026-10-01 14053613286784 Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II 05.519.106S 05.519.106S 2026-10-01 14053613286791 Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II 05.519.113S 05.519.113S 2026-10-01 14053613286944 Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II 05.519.304S 05.519.304S 2026-10-01 14053613001493 KOMET Surgical Bur NC0303.004..M0 NC0303.004. 2023-01-31 E226000081AU1 KOMET Dental Tungsten Carbide Burs H1.313.018.AU H1.313.018 2023-01-19 14053613298343 KOMET Surgical Bur S27261.501..M0 S27261.501. 2026-09-30 14053613298350 KOMET Surgical Bur S27262.501..M0 S27262.501. 2026-09-30 E226000077AU1 KOMET Dental Tungsten Carbide Burs H1.313.010.AU H1.313.010 2023-01-19 E226100004991 KOMET Dental Diamond Instruments S5878.314.016.A2 S5878.314.016 2023-02-01 14053613286630 Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II 05.005.201S 05.005.201S 2026-09-28
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