FDA.report

KOMET Dental Tungsten Carbide Burs

Primary DI
E226100023402
Brand
KOMET Dental Tungsten Carbide Burs
Company
Gebr. Brasseler GmbH & Co. KG
Model
H1SU.316.014.GS
Catalog number
H1SU.316.014
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

Related Records

Product Codes

CodeName
EJLBUR, DENTAL

Product Code Classifications

CodeDeviceSpecialtyClass
EJLBur, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
E226100023402PackageHIBCC25In Commercial Distribution
E226100023401PrimaryHIBCC0

GMDN Terms

TermDefinition
Carbide dental bur, single-useA 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 single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
317409001
Device count
1
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

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24053613265496Steinmann PinSP-80005-00-00SP-80005-00-002026-03-20
24053613296209Bur, tapered, round shank08227100082271002026-03-20
24053613295929Bur, Round, round shank08226780082267802026-03-11
24053613295936Bur, Round, round shank08226790082267902026-03-11
24053613296131Bur, Round, round shank08227000082270002026-03-11
24053613296193Bur, tapered, round shank08227090082270902026-03-11
24053613296803Bur, Round, round shank08227750082277502026-03-11
24053613297121Bur, cylindrical, round shank08228070082280702026-03-11
24053613297190Bur, Egg / egg shaped, round shank08228140082281402026-03-11
24053613297206Bur, Egg / egg shaped, round shank08228150082281502026-03-11
24053613297220Bur, Round, round shank08228170082281702026-03-11
04053613298315Guide Pin Smooth800-05-215800-05-2152026-03-11
84053613294535Guide Pin Smooth800-05-215800-05-2152026-01-30
24053613295721Shannon Recta X-LargaG01 S5330G01 S53302026-01-23
24053613284978Saw Blade5109-098-0435109-098-0432022-12-08
E226048483R18KOMET Root Canal Files17331.654.012.R117331.654.0122026-01-13
14053613294581Tech Ancillary Pack150-00-002150-00-0022026-01-08
24053613294557Guide Drill Pin800-02-508800-02-5082026-01-06
14053613294574Tech Knee Pack150-00-001150-00-0012026-01-06
E226007158R18KOMET Root Canal Files17321.654.006.R117321.654.0062025-12-10

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00810126508317Sabur by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEJL2026-03-11
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