FDA.reportPublic FDA data

KOMET Dental Tungsten Carbide Burs

Primary DI
E226000092A11
Brand
KOMET Dental Tungsten Carbide Burs
Company
Gebr. Brasseler GmbH & Co. KG
Model
H1.314.016.A1
Catalog number
H1.314.016
Published
2023-01-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
E226000092A11PrimaryHIBCC0

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
1
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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
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
E226000108G11KOMET Surgical BurH1.316.018.G1H1.316.0182023-01-31
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
08404535036985Brasseler USAPeter Brasseler Holdings, LLCEJL2026-10-01
00810194409387AiraAIRA, LLCEJL2026-08-25
00810194409431AiraAIRA, LLCEJL2026-08-25
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00810194409462AiraAIRA, LLCEJL2026-08-25
00810194409486AiraAIRA, LLCEJL2026-08-25
00810194409523AiraAIRA, LLCEJL2026-08-25
00810194409547AiraAIRA, LLCEJL2026-08-25
00810194409554AiraAIRA, LLCEJL2026-08-25
00810194409585AiraAIRA, LLCEJL2026-08-25
00810194409592AiraAIRA, LLCEJL2026-08-25
00810194409608AiraAIRA, LLCEJL2026-08-25
00810194409622AiraAIRA, LLCEJL2026-08-25
00810194409646AiraAIRA, LLCEJL2026-08-25
00810194409776AiraAIRA, LLCEJL2026-08-25
00810194409837AiraAIRA, LLCEJL2026-08-25
00810194409912AiraAIRA, LLCEJL2026-08-25
00810194409943AiraAIRA, LLCEJL2026-08-25
00810194409950AiraAIRA, LLCEJL2026-08-25
00810194409981AiraAIRA, LLCEJL2026-08-25
00810226100022AiraAIRA, LLCEJL2026-08-25
00810226100060AiraAIRA, LLCEJL2026-08-25
00810226100138AiraAIRA, LLCEJL2026-08-25
00810226100213AiraAIRA, LLCEJL2026-08-25
00810226100268AiraAIRA, LLCEJL2026-08-25
00810226100275AiraAIRA, LLCEJL2026-08-25
00810226100572AiraAIRA, LLCEJL2026-08-25
00810226100985AiraAIRA, LLCEJL2026-08-25
00810226101043AiraAIRA, LLCEJL2026-08-25
00810226101050AiraAIRA, LLCEJL2026-08-25