FDA.reportPublic FDA data

KOMET Surgical Bur

Primary DI
E226000108G11
Brand
KOMET Surgical Bur
Company
Gebr. Brasseler GmbH & Co. KG
Model
H1.316.018.G1
Catalog number
H1.316.018
Published
2023-01-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
false

Product Codes#

Code, Name table
CodeName
GFFBUR, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFFBur, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E226000108G11PrimaryHIBCC0
E226000108G18Unit 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.

Regulatory Flags#

DUNS number
317409001
Device count
5
DM exempt
true
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 DIBrandModelCatalogPublished
14053613001738KOMET Surgical BurNC0310.010..M0NC0310.010.2023-01-31
E226000085G11KOMET Dental Tungsten Carbide BursH1.314.006.G1H1.314.0062023-01-19
E226000087AL1KOMET Dental Tungsten Carbide BursH1.314.008.ALH1.314.0082023-01-19
E226000091G11KOMET Dental Tungsten Carbide BursH1.314.014.G1H1.314.0142023-01-24
E226000092A11KOMET Dental Tungsten Carbide BursH1.314.016.A1H1.314.0162023-01-24
E226000104AL1KOMET Surgical BurH1.316.010.ALH1.316.0102023-01-24
E226000104G11KOMET Surgical BurH1.316.010.G1H1.316.0102023-01-24
E226000106AL1KOMET Surgical BurH1.316.014.ALH1.316.0142023-01-27
E226000109G11KOMET Surgical BurH1.316.023.G1H1.316.0232023-01-31
E226000150AU1KOMET Dental Tungsten Carbide BursH2.313.008.AUH2.313.0082023-01-31
14053613286302Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.422S05.005.422S2026-10-05
14053613286326Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.423S05.005.423S2026-10-05
14053613286418Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.465S05.005.465S2026-10-05
14053613286432Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.441S05.005.441S2026-10-05
14053613286661Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.203S05.005.203S2026-10-05
14053613286708Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.303S05.005.303S2026-10-05
14053613286814Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.519.200S05.519.200S2026-10-05
14053613287026Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.002S05.005.002S2026-10-05
E226000077AU1KOMET Dental Tungsten Carbide BursH1.313.010.AUH1.313.0102023-01-19
E226000081AU1KOMET Dental Tungsten Carbide BursH1.313.018.AUH1.313.0182023-01-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817438028762N/AOmega Surgical Instruments IncGFF2026-10-05
14053613298343KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2026-09-30
14053613298350KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2026-09-30
14053613293133KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2026-09-25
05051471225985De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGFF2026-08-01
00817438028724N/AOmega Surgical Instruments IncGFF2026-07-24
00817438028755N/AOmega Surgical Instruments IncGFF2026-07-21
10080196377244MEDLINEMEDLINE INDUSTRIES, INC.GFF2025-01-29
10080196385560MEDLINEMEDLINE INDUSTRIES, INC.GFF2025-01-29
14053613001493KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-31
14053613001738KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-31
E226000109G11KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-31
E226000106AL1KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-27
E226000104AL1KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-24
E226000104G11KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-24
10845854012581VORTEX, STERLINGConmed CorporationGFF2023-01-19
10845854012598VORTEX, STERLINGConmed CorporationGFF2023-01-19
10845854017791STERLINGConmed CorporationGFF2023-01-19
10845854029626STERLINGConmed CorporationGFF2023-01-19
10845854029671LIGHTNING, STERLINGConmed CorporationGFF2023-01-19
10845854040621ULTRATIGERConmed CorporationGFF2023-01-19
10080196377299MedlineMEDLINE INDUSTRIES, INC.GFF2022-05-12
10080196385577MedlineMEDLINE INDUSTRIES, INC.GFF2022-05-12
10884389198537MedlineMEDLINE INDUSTRIES, INC.GFF2022-05-12
10653160274797CenturionCENTURION MEDICAL PRODUCTS CORPORATIONGFF2022-01-01
10653160276982CenturionCENTURION MEDICAL PRODUCTS CORPORATIONGFF2022-01-01
10653160281672CenturionCENTURION MEDICAL PRODUCTS CORPORATIONGFF2022-01-01
10653160282402CenturionCENTURION MEDICAL PRODUCTS CORPORATIONGFF2022-01-01
10653160290797CenturionCENTURION MEDICAL PRODUCTS CORPORATIONGFF2022-01-01
10653160321668CenturionCENTURION MEDICAL PRODUCTS CORPORATIONGFF2022-01-01