FDA.report

Migtools

Primary DI
07898730062015
Brand
Migtools
Company
MIG TOOLS INDUSTRIA E COMERCIO LTDA
Model
CAD CAM Burs
Device description
CAD/CAM BURS IMES T11 Ø2.5MM PMMA/WAX/PEEK COATED
Published
2025-02-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
EJLBur, Dental

Product Code Classifications

CodeDeviceSpecialtyClass
EJLBur, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07898730062015PrimaryGS10

GMDN Terms

TermDefinition
Steel dental bur, reusableA rotary cutting device made from high-grade carbon steel with the working end typically formed with cutting planes, e.g., spiralled flutes, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, such as teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials intended for use in the fabrication of dental devices. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
945033795
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

Primary DIBrandModelCatalogPublished
07898730060202MigtoolsMaxicut Burs2025-02-26
07898730060219MigtoolsMaxicut Burs2025-02-26
07898730060226MigtoolsMaxicut Burs2025-02-26
07898730060233MigtoolsMaxicut Burs2025-02-26
07898730060240MigtoolsMaxicut Burs2025-02-26
07898730060257MigtoolsMaxicut Burs2025-02-26
07898730060264MigtoolsMaxicut Burs2025-02-26
07898730060271MigtoolsMaxicut Burs2025-02-26
07898730060288MigtoolsMinicut Burs2025-02-26
07898730060301MigtoolsMaxicut Burs2025-02-26
07898730060318MigtoolsMaxicut Burs2025-02-26
07898730060325MigtoolsMaxicut Burs2025-02-26
07898730060332MigtoolsMaxicut Burs2025-02-26
07898730060349MigtoolsMaxicut Burs2025-02-26
07898730060356MigtoolsMaxicut Burs2025-02-26
07898730060363MigtoolsMaxicut Burs2025-02-26
07898730060370MigtoolsMaxicut Burs2025-02-26
07898730060387MigtoolsMaxicut Burs2025-02-26
07898730060394Migtools Maxicut Burs2025-02-26
07898730060400MigtoolsMaxicut Burs2025-02-26

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00810126508270Sabur by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEJL2026-03-11
00810126508294Sabur by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEJL2026-03-11
00810126508300Sabur by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEJL2026-03-11
00810126508317Sabur by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEJL2026-03-11
00810126508324Sabur by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEJL2026-03-11
07908738731940DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEJL2026-03-10
07908738730585DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEJL2026-03-10
07908738730592DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEJL2026-03-10
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07908738730721DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEJL2026-03-10
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07908738730790DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEJL2026-03-10
07908738730806DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEJL2026-03-10
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