FDA.reportPublic FDA data

KOMET Dental Tungsten Carbide Burs

Primary DI
E226000493AU1
Brand
KOMET Dental Tungsten Carbide Burs
Company
Gebr. Brasseler GmbH & Co. KG
Model
H41.314.023.AU
Catalog number
H41.314.023
Published
2023-01-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EJLBUR, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJLBur, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E226000493AU1PrimaryHIBCC0
E226000493AU8Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Carbide dental bur, reusableA rotary cutting device made of high-grade steel, the working end of which is made from, or coated with, tungsten carbide, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, e.g., teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
317409001
Device count
5
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14053613286364Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.431S05.005.431S2026-10-01
14053613286395Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.433S05.005.433S2026-10-01
14053613286425Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.442S05.005.442S2026-10-01
14053613286449Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.451S05.005.451S2026-10-01
14053613286456Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.452S05.005.452S2026-10-01
14053613286470Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.453S05.005.453S2026-10-01
14053613286487Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.454S05.005.454S2026-10-01
14053613286494Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.445S05.005.445S2026-10-01
14053613286722Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.305S05.005.305S2026-10-01
14053613286777Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.005S05.005.005S2026-10-01
14053613286784Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.519.106S05.519.106S2026-10-01
14053613286791Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.519.113S05.519.113S2026-10-01
14053613286944Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.519.304S05.519.304S2026-10-01
14053613001493KOMET Surgical BurNC0303.004..M0NC0303.004.2023-01-31
E226000081AU1KOMET Dental Tungsten Carbide BursH1.313.018.AUH1.313.0182023-01-19
14053613298343KOMET Surgical BurS27261.501..M0S27261.501.2026-09-30
14053613298350KOMET Surgical BurS27262.501..M0S27262.501.2026-09-30
E226000077AU1KOMET Dental Tungsten Carbide BursH1.313.010.AUH1.313.0102023-01-19
E226100004991KOMET Dental Diamond InstrumentsS5878.314.016.A2S5878.314.0162023-02-01
14053613286630Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.201S05.005.201S2026-09-28

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