FDA.report

MANI CARBIDE BURS

Primary DI
74546951534591
Brand
MANI CARBIDE BURS
Company
MANI, INC.
Model
1557
Device description
MANI CARBIDE BURS
Published
2022-10-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
04546951534592PrimaryGS10
74546951534591Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04546951534592045469515345924546951534592
7454695153459174546951534591

GMDN Terms

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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
690622428
Device count
10
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
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
74546951616426MANI MICRO FORCEPSSquare Type 27G2026-03-03
74546951616433MANI MICRO FORCEPSRound Type 27G2026-03-03
74546951616440MANI MICRO FORCEPSEXFine Type 27G2026-03-03
74546951619090MANI MICRO FORCEPSSquare Type 25G2026-03-03
74546951619106MANI MICRO FORCEPSRound Type 25G2026-03-03
74546951635595MANI MICRO FORCEPSILM 25G Slim Grip 33mm2026-03-03
74546951635601MANI MICRO FORCEPSILM 27G Slim Grip 33mm2026-03-03
74546951635618MANI MICRO FORCEPSSquare 25G Slim Grip 28mm2026-03-03
74546951635625MANI MICRO FORCEPSRound 25G Slim Grip 28mm2026-03-03
74546951635632MANI MICRO FORCEPSILM 25G Slim Grip 28mm2026-03-03
74546951635649MANI MICRO FORCEPSSquare 27G Slim Grip 28mm2026-03-03
74546951635656MANI MICRO FORCEPSRound 27G Slim Grip 28mm2026-03-03
74546951635663MANI MICRO FORCEPSILM 27G Slim Grip 28mm2026-03-03
74546951635670MANI MICRO FORCEPSEXFine 27G Slim Grip 28mm2026-03-03
74546951635687MANI MICRO FORCEPSSquare 25G Wide Grip 33mm2026-03-03
74546951635694MANI MICRO FORCEPSRound 25G Wide Grip 33mm2026-03-03
74546951635700MANI MICRO FORCEPSILM 25G Wide Grip 33mm2026-03-03
74546951635717MANI MICRO FORCEPSSquare 27G Wide Grip 33mm2026-03-03
74546951635724MANI MICRO FORCEPSRound 27G Wide Grip 33mm2026-03-03
74546951635731MANI MICRO FORCEPSILM 27G Wide Grip 33mm2026-03-03

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
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