FDA.report

OSUNG MND

Primary DI
08800075623997
Brand
OSUNG MND
Company
OSUNG MND Co., Ltd.
Model
PLG0-1
Device description
A hand-held manual dental instrument intended for packing amalgam or direct filling gold (Au). It may be smooth or serrated in design and flat or curved in shape. 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
EKGCondenser, Amalgam And Foil, Operative

Product Code Classifications

CodeDeviceSpecialtyClass
EKGCondenser, Amalgam And Foil, OperativeDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800075623997PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800075623997088000756239978800075623997

GMDN Terms

TermDefinition
Dental amalgam condenser, reusableA hand-held manual dental instrument intended for packing amalgam or direct filling gold (Au). It may be smooth or serrated in design and flat or curved in shape. 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

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00840018671867Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKG2026-02-10
00840018671904Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKG2026-02-10
00840018666092Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKG2026-02-09
00840018662506Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKG2026-01-29
00840018663275Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKG2026-01-29
00840018661325Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKG2026-01-28
00840018661387Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKG2026-01-28
00840018661769Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKG2026-01-28
00840018661936Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKG2026-01-28
05010058178106InstrapacROBINSON HEALTHCARE LIMITEDEKG2025-06-23
00889813065976Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKG2024-12-12
00889813065952Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKG2024-11-30
00889813065969Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKG2024-11-30
00889813065983Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKG2024-11-30
00889813065990Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKG2024-11-30
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00889813066027Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKG2024-11-30
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00889813066010Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKG2024-10-01
00842517118553Karl SchumacherKarl Schumacher Dental, LLCEKG2024-05-06
00842517118560Karl SchumacherKarl Schumacher Dental, LLCEKG2024-05-06
00842517118577Karl SchumacherKarl Schumacher Dental, LLCEKG2024-05-06
00842517118584Karl SchumacherKarl Schumacher Dental, LLCEKG2024-05-06
00842517118591Karl SchumacherKarl Schumacher Dental, LLCEKG2024-05-06
08800075604668OSUNG MNDOSUNG MND Co., Ltd.EKG2024-03-04
08800075604675OSUNG MNDOSUNG MND Co., Ltd.EKG2024-03-04
08800075609670OSUNG MNDOSUNG MND Co., Ltd.EKG2024-03-04
08800075609717OSUNG MNDOSUNG MND Co., Ltd.EKG2024-03-04