FDA.reportPublic FDA data

KOMET Dental Tungsten Carbide Burs

Primary DI
E226000161G11
Brand
KOMET Dental Tungsten Carbide Burs
Company
Gebr. Brasseler GmbH & Co. KG
Model
H2.314.010.G1
Catalog number
H2.314.010
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
EJLBUR, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJLBur, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E226000161G11PrimaryHIBCC0
E226000161G18Unit 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
E226000160A61KOMET Dental Tungsten Carbide BursH2.314.009.A6H2.314.0092023-01-31
E226000161A11KOMET Dental Tungsten Carbide BursH2.314.010.A1H2.314.0102023-01-31
E226000163AU1KOMET Dental Tungsten Carbide BursH2.314.014.AUH2.314.0142023-01-31
E226000165G11KOMET Dental Tungsten Carbide BursH2.314.018.G1H2.314.0182023-01-31
E226000200A11KOMET Dental Tungsten Carbide BursH7.314.006.A1H7.314.0062023-01-31
E226000295AL1KOMET Dental Tungsten Carbide BursH21.314.009.ALH21.314.0092023-01-31
E226000331AL1KOMET Dental Tungsten Carbide BursH23.314.009.ALH23.314.0092023-01-31
E226000402AU1KOMET Surgical BurH31.316.012.AUH31.316.0122023-01-31
E226000404A21KOMET Surgical BurH31.316.016.A2H31.316.0162023-01-31
14053613295632Reciprocating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II, UNIUM05.005.905S05.005.905S2026-10-20
14053613295656Reciprocating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II, UNIUM05.005.907S05.005.907S2026-10-20
14053613286692Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.301S05.005.301S2026-10-19
14053613286975Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.072S05.005.072S2026-10-19
14053613286999Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.074S05.005.074S2026-10-19
14053613287002Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.075S05.005.075S2026-10-19
14053613287019Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.302S05.005.302S2026-10-19
14053613286562Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.501S05.005.501S2026-10-14
14053613286654Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.202S05.005.202S2026-10-14
14053613286906Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.519.190S05.519.190S2026-10-14
14053613298657KOMET GUIDE PIN/SCREWGP004.076.030.M4GP004.076.0302026-10-14

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Primary DI, Brand, Company table
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