FDA.report

OSUNG MND

Primary DI
08800075626172
Brand
OSUNG MND
Company
OSUNG MND Co., Ltd.
Model
2MHS1
Device description
A hand-held, manual device designed to hold and facilitate manipulation of a non-powered, non-rotary dental instrument (e.g., endodontic file/rasp, implant extractor). It is designed to accept the patient-contact endpiece (not included) for ease of handling. This is a reusable device.
Published
2024-02-23
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
EJBHandle, Instrument, Dental

Product Code Classifications

CodeDeviceSpecialtyClass
EJBHandle, Instrument, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800075626172PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800075626172088000756261728800075626172

GMDN Terms

TermDefinition
Manual non-rotary dental instrument handleA hand-held, manual device designed to hold and facilitate manipulation of a non-powered, non-rotary dental instrument (e.g., endodontic file/rasp, implant extractor). It is designed to accept the patient-contact endpiece (not included) for ease of handling. This is a reusable 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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00348783010206Premier Mirror HandlesPREMIER DENTAL PRODUCTS COMPANYEJB2026-03-17
G1493807306TBS DentalACME ENTERPRISE.EJB2026-03-02
00841013120459Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EJB2026-01-06
00841013120466Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EJB2026-01-06
30371347019668Advance Dental ProductsThe Atlanta Dental Supply CompanyEJB2025-11-18
30371347019675Advance Dental ProductsThe Atlanta Dental Supply CompanyEJB2025-11-18
30371347019682Advance Dental ProductsThe Atlanta Dental Supply CompanyEJB2025-11-18
30371347019699Advance Dental ProductsThe Atlanta Dental Supply CompanyEJB2025-11-18
00371347017724Advance Dental ProductsThe Atlanta Dental Supply CompanyEJB2025-11-18
00371347017748Advance Dental ProductsThe Atlanta Dental Supply CompanyEJB2025-11-18
00883205032164Slide PackerULTRADENT PRODUCTS, INC.EJB2025-08-21
00883205032157Slide PackerULTRADENT PRODUCTS, INC.EJB2025-08-19
08806343925183ever KITShinhung MST Co., Ltd.EJB2025-07-28
08806343925213TAPER KITShinhung MST Co., Ltd.EJB2025-07-28
08806343925220GUIDE KITShinhung MST Co., Ltd.EJB2025-07-28
08057639710567Specialist OrganizerMC BIO SRLEJB2025-06-23
08057639710574Tip with Indexable StopMC BIO SRLEJB2025-06-23
08057639710598Offset Tip SPMC BIO SRLEJB2025-06-23
08057639710604Long Tip SPMC BIO SRLEJB2025-06-23
08057639710628GBR MODULAR SETMC BIO SRLEJB2025-06-23
08057639712066Handle - Straight MDFMC BIO SRLEJB2025-06-23
08057639712073Handle - Straight - ErgalMC BIO SRLEJB2025-06-23
08057639712080Handle - Straight SP (TiN)MC BIO SRLEJB2025-06-23
08057639712097Handle - Asym. - ErgalMC BIO SRLEJB2025-06-23
08057639712103Handle - Asym. - SP (TiN)MC BIO SRLEJB2025-06-23
08057639712110Handle - Asym. - TitaniumMC BIO SRLEJB2025-06-23
08056992093119Starter SetMC BIO SRLEJB2025-06-20
08056992093126Basic SetMC BIO SRLEJB2025-06-20
08056992093133Advance SetMC BIO SRLEJB2025-06-20
08806343922328Short Drill KitShinhung MST Co., Ltd.EJB2025-06-16