FDA.report

OSUNG MND

Primary DI
08800075604873
Brand
OSUNG MND
Company
OSUNG MND Co., Ltd.
Model
CV3S
Device description
A hand-held manual dental instrument intended to be used for producing and perfecting anatomical forms in dental amalgam restorations, typically by cutting, scraping, paring, and smoothing finishes and modelling patterns intraorally. It will typically be a double-ended instrument with working ends of various shapes and designs, and a central handle. This is a reusable device.
Published
2024-02-21
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
EKHCarver, Dental Amalgam, Operative

Product Code Classifications

CodeDeviceSpecialtyClass
EKHCarver, Dental Amalgam, OperativeDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800075604873PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800075604873088000756048738800075604873

GMDN Terms

TermDefinition
Dental restoration carver, amalgam, reusableA hand-held manual dental instrument intended to be used for producing and perfecting anatomical forms in dental amalgam restorations, typically by cutting, scraping, paring, and smoothing finishes and modelling patterns intraorally. It will typically be a double-ended instrument with working ends of various shapes and designs, and a central handle. 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
00348783009156Premier CarversPREMIER DENTAL PRODUCTS COMPANYEKH2026-03-17
00348783009231Premier CarversPREMIER DENTAL PRODUCTS COMPANYEKH2026-03-17
00840018674035Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKH2026-02-11
00840018674134Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKH2026-02-11
00840018674141Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKH2026-02-11
00840018674158Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKH2026-02-11
05010058180185InstrapacROBINSON HEALTHCARE LIMITEDEKH2025-06-23
00889813066058Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKH2025-02-12
00889813066065Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKH2025-02-12
00889813066089Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKH2025-02-12
00889813066096Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKH2025-02-12
00889813066102Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKH2025-02-12
00889813066119Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKH2025-02-12
00889813066126Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKH2025-02-12
00889813066133Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKH2025-02-12
00889813066140Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKH2025-02-12
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00813677025111PDT, Inc.PDT, INC.EKH2024-07-05
00813677021465PDT, Inc.PDT, INC.EKH2024-06-27
00842517106970Karl SchumacherKarl Schumacher Dental, LLCEKH2024-05-06
00842517106987Karl SchumacherKarl Schumacher Dental, LLCEKH2024-05-06
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00842517107014Karl SchumacherKarl Schumacher Dental, LLCEKH2024-05-06
00842517107021Karl SchumacherKarl Schumacher Dental, LLCEKH2024-05-06
00842517107038Karl SchumacherKarl Schumacher Dental, LLCEKH2024-05-06
00842517118225Karl SchumacherKarl Schumacher Dental, LLCEKH2024-05-06
00842517118683Karl SchumacherKarl Schumacher Dental, LLCEKH2024-05-06
00842517118690Karl SchumacherKarl Schumacher Dental, LLCEKH2024-05-06
00842517118706Karl SchumacherKarl Schumacher Dental, LLCEKH2024-05-06