FDA.report

OSUNG MND

Primary DI
08800075615336
Brand
OSUNG MND
Company
OSUNG MND Co., Ltd.
Model
197TR-SS21
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
2024-02-28
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
true

Related Records

Product Codes

CodeName
DZPInstrument, Diamond, Dental

Product Code Classifications

CodeDeviceSpecialtyClass
DZPInstrument, Diamond, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800075615336PrimaryGS10

GMDN Terms

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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
688207479
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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
08800075628350OSUNG MNDBSF-5P2025-06-23
08800075627131OSUNG MNDSRTHD2025-04-11
08800075626714OSUNG MNDDCM010F2024-03-22
08800075626721OSUNG MNDDCM012F2024-03-22
08800075626738OSUNG MNDDCM014F2024-03-22
08800075626745OSUNG MNDDCM016F2024-03-22
08800075626752OSUNG MNDDCL010F2024-03-22
08800075626769OSUNG MNDDCL012F2024-03-22
08800075626776OSUNG MNDDCL014F2024-03-22
08800075626783OSUNG MNDDCL016F2024-03-22
08800075626790OSUNG MNDDCXL014F2024-03-22
08800075626806OSUNG MNDDCXL016F2024-03-22
08800075626813OSUNG MNDTRL010F2024-03-22
08800075626820OSUNG MNDTRL012F2024-03-22
08800075626837OSUNG MNDTRL014F2024-03-22
08800075626844OSUNG MNDTRXL012F2024-03-22
08800075626851OSUNG MNDTRXL014F2024-03-22
08800075626868OSUNG MNDPSM019C2024-03-22
08800075626875OSUNG MNDFBL019EF2024-03-22
08800075626882OSUNG MNDFBL025F2024-03-22

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D690W801014M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W801016M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W801018M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W801021C0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W801021M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W801023M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W801L016C0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W801L016M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W801L018M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W801L021M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W802014M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W802016M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W805010M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W805014C0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W805014M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W805016M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W811031M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W830008M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W830010M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16