FDA.reportPublic FDA data

OSUNG MND

Primary DI
08800075628909
Brand
OSUNG MND
Company
OSUNG MND Co., Ltd.
Model
FSM010
Device description
A rotary cutting device made of high-grade steel with the working end coated with particles of diamond, 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 single-use device.
Published
2026-04-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
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
08800075628909PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800075628909088000756289098800075628909

GMDN Terms#

Term, Definition table
TermDefinition
Diamond dental bur, single-useA rotary cutting device made of high-grade steel with the working end coated with particles of diamond, 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 single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
688207479
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
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
08800075629524OSUNG MNDBSF-BHCL2026-05-14
08800075629531OSUNG MNDBSF-5P-BHCL2026-05-14
08800075628749OSUNG MNDCRP019EF2026-04-01
08800075628756OSUNG MNDFBL0192026-04-01
08800075628763OSUNG MNDRP015EF2026-04-01
08800075628770OSUNG MNDCRP019SF2026-04-01
08800075628787OSUNG MNDFBL019SF2026-04-01
08800075628794OSUNG MNDRP015SF2026-04-01
08800075628800OSUNG MNDCIS0122026-04-01
08800075628817OSUNG MNDCIS013F2026-04-01
08800075628824OSUNG MNDCIS0162026-04-01
08800075628831OSUNG MNDCISS0132026-04-01
08800075628848OSUNG MNDCISS0162026-04-01
08800075628855OSUNG MNDDCM009F2026-04-01
08800075628862OSUNG MNDDCXL018F2026-04-01
08800075628879OSUNG MNDDCXXL014F2026-04-01
08800075628886OSUNG MNDFBL0232026-04-01
08800075628893OSUNG MNDFBL0252026-04-01
08800075628916OSUNG MNDFSS009F2026-04-01
08800075628923OSUNG MNDIM008F2026-04-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776426736MillenniumAvalign Technologies, Inc.EJL2026-08-19
00190776426743MillenniumAvalign Technologies, Inc.EJL2026-08-19
04099797000726Drill for CT-tubeALTATEC GmbHEJL2026-08-17
04099797000733Drill for CT-tubeALTATEC GmbHEJL2026-08-17
04099797010664Surgery set CERALOG® PROGRESSIVE-LINE FlexALTATEC GmbHEJL2026-08-17
04099797011661Guide Template drillALTATEC GmbHEJL2026-08-17
04099797011678Guide Template drillALTATEC GmbHEJL2026-08-17
04099797011920Drill extensionALTATEC GmbHEJL2026-08-17
04099797012026Depth stopALTATEC GmbHEJL2026-08-17
04099797012033Depth stopALTATEC GmbHEJL2026-08-17
04099797012040Depth stopALTATEC GmbHEJL2026-08-17
04099797012057Depth stopALTATEC GmbHEJL2026-08-17
04099797012064Depth stopALTATEC GmbHEJL2026-08-17
04099797012071Depth stopALTATEC GmbHEJL2026-08-17
04099797012088Depth stopALTATEC GmbHEJL2026-08-17
04099797012095Depth stopALTATEC GmbHEJL2026-08-17
04099797012101Depth stopALTATEC GmbHEJL2026-08-17
04099797012118Point drillALTATEC GmbHEJL2026-08-17
04099797012125SCREW-LINE Form drillALTATEC GmbHEJL2026-08-17
04099797012132SCREW-LINE TapALTATEC GmbHEJL2026-08-17
04099797012354Pilot drill SetALTATEC GmbHEJL2026-08-17
04099797012361Pilot drill SetALTATEC GmbHEJL2026-08-17
04099797012378SCREW-LINE Form drillALTATEC GmbHEJL2026-08-17
04099797012385SCREW-LINE Form drillALTATEC GmbHEJL2026-08-17
04099797012392SCREW-LINE Form drillALTATEC GmbHEJL2026-08-17
04099797012408PROGRESSIVE-LINE Dense bone drillALTATEC GmbHEJL2026-08-17
04099797012415PROGRESSIVE-LINE Dense bone drillALTATEC GmbHEJL2026-08-17
04099797012422PROGRESSIVE-LINE Dense bone drillALTATEC GmbHEJL2026-08-17
04099797012439PROGRESSIVE-LINE Dense bone drillALTATEC GmbHEJL2026-08-17
04099797012446PROGRESSIVE-LINE Dense bone drill 2ALTATEC GmbHEJL2026-08-17