FDA.reportPublic FDA data

KOMET Dental Tungsten Carbide Burs

Primary DI
E226000297A21
Brand
KOMET Dental Tungsten Carbide Burs
Company
Gebr. Brasseler GmbH & Co. KG
Model
H21.314.012.A2
Catalog number
H21.314.012
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
E226000297A21PrimaryHIBCC0
E226000297A28Unit 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
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14053613286586Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.106S05.005.106S2026-10-07
14053613286593Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.102S05.005.102S2026-10-07
14053613286616Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.104S05.005.104S2026-10-07
14053613286647Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.405S05.005.405S2026-10-07
14053613286678Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.204S05.005.204S2026-10-07
14053613286746Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.007S05.005.007S2026-10-07
14053613286760Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.004S05.005.004S2026-10-07
14053613286951Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.519.305S05.519.305S2026-10-07
14053613286968Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.071S05.005.071S2026-10-07
14053613295663Reciprocating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II, UNIUM05.005.909S05.005.909S2026-10-07
14053613295670Reciprocating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II, UNIUM05.005.912S05.005.912S2026-10-07
14053613295687Reciprocating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II, UNIUM05.005.913S05.005.913S2026-10-07
14053613298145Oscillating Saw Blade for Arthrex 300AR-300-001AR-300-0012026-10-07
14053613298152Oscillating Saw Blade for Arthrex 300AR-300-002AR-300-0022026-10-07
14053613298169Oscillating Saw Blade for Arthrex 300AR-300-004AR-300-0042026-10-07
14053613298176Oscillating Saw Blade for Arthrex 300AR-300-005AR-300-0052026-10-07
14053613298183Oscillating Saw Blade for Arthrex 300AR-300-006AR-300-0062026-10-07
14053613298190Oscillating Saw Blade for Arthrex 300AR-300-007AR-300-0072026-10-07
14053613298206Reciprocating Saw Blade for ConMed®/Linvatec® Hall®AR-400-201AR-400-2012026-10-07

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