FDA.reportPublic FDA data

MANI CARBIDE BURS

Primary DI
04546951601515
Brand
MANI CARBIDE BURS
Company
MANI, INC.
Model
7 (CA)
Device description
MANI CARBIDE BURS
Published
2026-04-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
04546951601515PrimaryGS10
74546951601514Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04546951601515045469516015154546951601515
7454695160151474546951601514

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
690622428
Device count
10
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14546951639997MANI MICRO FORCEPSSquare 25G 360 Grip 33mm2026-09-18
14546951640009MANI MICRO FORCEPSRound 25G 360 Grip 33mm2026-09-18
14546951640016MANI MICRO FORCEPSILM 25G 360 Grip 33mm2026-09-18
14546951640023MANI MICRO FORCEPSSquare 27G 360 Grip 33mm2026-09-18
14546951640030MANI MICRO FORCEPSRound 27G 360 Grip 33mm2026-09-18
14546951640047MANI MICRO FORCEPSILM 27G 360 Grip 33mm2026-09-18
14546951640054MANI MICRO FORCEPSEXFine 27G 360 Grip 33mm2026-09-18
14546951640061MANI MICRO FORCEPSSquare 25G 360 Grip 28mm2026-09-18
14546951640078MANI MICRO FORCEPSRound 25G 360 Grip 28mm2026-09-18
14546951640085MANI MICRO FORCEPSILM 25G 360 Grip 28mm2026-09-18
14546951640092MANI MICRO FORCEPSSquare 27G 360 Grip 28mm2026-09-18
14546951640108MANI MICRO FORCEPSRound 27G 360 Grip 28mm2026-09-18
14546951640115MANI MICRO FORCEPSILM 27G 360 Grip 28mm2026-09-18
14546951640122MANI MICRO FORCEPSEXFine 27G 360 Grip 28mm2026-09-18
14546951616721MANI Ophthalmic KnifeMSL24CH Slit-Angled 2.4mm CH2026-07-23
14546951627383MANI Ophthalmic KnifeMSL22CH Slit-Angled 2.2mm CH2026-07-23
14546951627390MANI Ophthalmic KnifeMSL27CH Slit-Angled 2.75mm CH2026-07-23
14546951638990MANI Ophthalmic KnifeMSL16MV-02 Slit Angled 1.6mm2026-04-23
14546951618787MANI TRABECULOTOMY HOOKMTH-S TRABECULOTOMY HOOK Straight Type2026-04-29
04546951534219MANI CARBIDE BURS6 (CA)2026-04-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810194409387AiraAIRA, LLCEJL2026-08-25
00810194409431AiraAIRA, LLCEJL2026-08-25
00810194409448AiraAIRA, LLCEJL2026-08-25
00810194409462AiraAIRA, LLCEJL2026-08-25
00810194409486AiraAIRA, LLCEJL2026-08-25
00810194409523AiraAIRA, LLCEJL2026-08-25
00810194409547AiraAIRA, LLCEJL2026-08-25
00810194409554AiraAIRA, LLCEJL2026-08-25
00810194409585AiraAIRA, LLCEJL2026-08-25
00810194409592AiraAIRA, LLCEJL2026-08-25
00810194409608AiraAIRA, LLCEJL2026-08-25
00810194409622AiraAIRA, LLCEJL2026-08-25
00810194409646AiraAIRA, LLCEJL2026-08-25
00810194409776AiraAIRA, LLCEJL2026-08-25
00810194409837AiraAIRA, LLCEJL2026-08-25
00810194409912AiraAIRA, LLCEJL2026-08-25
00810194409943AiraAIRA, LLCEJL2026-08-25
00810194409950AiraAIRA, LLCEJL2026-08-25
00810194409981AiraAIRA, LLCEJL2026-08-25
00810226100022AiraAIRA, LLCEJL2026-08-25
00810226100060AiraAIRA, LLCEJL2026-08-25
00810226100138AiraAIRA, LLCEJL2026-08-25
00810226100213AiraAIRA, LLCEJL2026-08-25
00810226100268AiraAIRA, LLCEJL2026-08-25
00810226100275AiraAIRA, LLCEJL2026-08-25
00810226100572AiraAIRA, LLCEJL2026-08-25
00810226100985AiraAIRA, LLCEJL2026-08-25
00810226101043AiraAIRA, LLCEJL2026-08-25
00810226101050AiraAIRA, LLCEJL2026-08-25
00810226101081AiraAIRA, LLCEJL2026-08-25