FDA.report

OSUNG MND

Primary DI
08800075605382
Brand
OSUNG MND
Company
OSUNG MND Co., Ltd.
Model
EXCL65-66
Device description
A hand-held manual dental instrument designed for cutting, scraping, and removing the carious dentine of a decayed tooth or other pathological bone tissue within the oral cavity. It is made of high-grade stainless steel typically designed as a double-ended instrument, having a central handle, with small, sharp, spoon-, scoop-, or spatula-shaped blades that have sharp cutting/gouging edges. This is a reusable device.
Published
2024-03-04
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
EKCExcavator, Dental, Operative

Product Code Classifications

CodeDeviceSpecialtyClass
EKCExcavator, Dental, OperativeDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800075605382PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800075605382088000756053828800075605382

GMDN Terms

TermDefinition
Dental excavator, reusableA hand-held manual dental instrument designed for cutting, scraping, and removing the carious dentine of a decayed tooth or other pathological bone tissue within the oral cavity. It is made of high-grade stainless steel typically designed as a double-ended instrument, having a central handle, with small, sharp, spoon-, scoop-, or spatula-shaped blades that have sharp cutting/gouging edges. 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
00348783008456Premier ExcavatorsPREMIER DENTAL PRODUCTS COMPANYEKC2026-03-17
00348783008586Premier ExcavatorsPREMIER DENTAL PRODUCTS COMPANYEKC2026-03-17
00348783008678Premier ExcavatorsPREMIER DENTAL PRODUCTS COMPANYEKC2026-03-17
00840018674219Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKC2026-02-11
00840018667693Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKC2026-02-10
00840018667709Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKC2026-02-10
00840018666511Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKC2026-02-09
00840018666979Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKC2026-02-09
00840018662575Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKC2026-01-29
00840018661394Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKC2026-01-28
05010058178113InstrapacROBINSON HEALTHCARE LIMITEDEKC2025-06-23
05010058182691InstrapacROBINSON HEALTHCARE LIMITEDEKC2025-06-23
05010058080348InstrapacROBINSON HEALTHCARE LIMITEDEKC2025-06-18
00889813065341Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKC2024-12-18
00889813065402Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKC2024-12-18
00889813065327Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKC2024-11-30
00889813065358Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKC2024-11-30
00889813065365Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKC2024-11-30
00889813065389Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKC2024-11-30
00889813065426Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKC2024-11-30
00889813065433Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKC2024-11-30
00889813065440Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKC2024-11-30
00889813065334Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKC2024-10-01
00889813065372Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKC2024-10-01
00889813065396Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKC2024-10-01
00889813065419Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKC2024-10-01
00813677024503PDT, Inc.PDT, INC.EKC2024-06-27
00813677024954PDT, Inc.PDT, INC.EKC2024-06-26
00842517109063Karl SchumacherKarl Schumacher Dental, LLCEKC2024-05-06
00842517109070Karl SchumacherKarl Schumacher Dental, LLCEKC2024-05-06