OSUNG MND

Primary DI
08800075612915
Brand
OSUNG MND
Company
OSUNG MND Co., Ltd.
Model
FSH3-7
Device description
A hand-held manual dental instrument that has various forms of ridged cutting surfaces at its working end(s) designed to scrape and smooth during a periodontal procedure. It is typically a one-piece instrument available in a variety of sizes and working end designs, including straight and curved ends, and often double-ended with a central handle; it is made of metal [e.g., stainless steel, titanium (Ti)]. This device is typically used to remove gross supragingival calculus, smooth the cementoenamel junction (CEJ), and remove overhanging margins of dental restorations. This is a reusable device.
Published
2024-02-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EKAFile, Margin Finishing, Operative

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKAFile, Margin Finishing, OperativeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800075612915PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800075612915088000756129158800075612915

GMDN Terms#

Term, Definition table
TermDefinition
Periodontal file/rasp, manualA hand-held manual dental instrument that has various forms of ridged cutting surfaces at its working end(s) designed to scrape and smooth during a periodontal procedure. It is typically a one-piece instrument available in a variety of sizes and working end designs, including straight and curved ends, and often double-ended with a central handle; it is made of metal [e.g., stainless steel, titanium (Ti)]. This device is typically used to remove gross supragingival calculus, smooth the cementoenamel junction (CEJ), and remove overhanging margins of dental restorations. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
688207479
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800075629524OSUNG MNDBSF-BHCL2026-05-14
08800075629531OSUNG MNDBSF-5P-BHCL2026-05-14
08800075628749OSUNG MNDCRP019EF2026-04-01
08800075628756OSUNG MNDFBL0192026-04-01
08800075628763OSUNG MNDRP015EF2026-04-01
08800075628770OSUNG MNDCRP019SF2026-04-01
08800075628787OSUNG MNDFBL019SF2026-04-01
08800075628794OSUNG MNDRP015SF2026-04-01
08800075628800OSUNG MNDCIS0122026-04-01
08800075628817OSUNG MNDCIS013F2026-04-01
08800075628824OSUNG MNDCIS0162026-04-01
08800075628831OSUNG MNDCISS0132026-04-01
08800075628848OSUNG MNDCISS0162026-04-01
08800075628855OSUNG MNDDCM009F2026-04-01
08800075628862OSUNG MNDDCXL018F2026-04-01
08800075628879OSUNG MNDDCXXL014F2026-04-01
08800075628886OSUNG MNDFBL0232026-04-01
08800075628893OSUNG MNDFBL0252026-04-01
08800075628909OSUNG MNDFSM0102026-04-01
08800075628916OSUNG MNDFSS009F2026-04-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800075612953OSUNG MNDOSUNG MND Co., Ltd.EKA2024-02-27
08800075612960OSUNG MNDOSUNG MND Co., Ltd.EKA2024-02-27
08800075623294OSUNG MNDOSUNG MND Co., Ltd.EKA2024-02-27
08800075612922OSUNG MNDOSUNG MND Co., Ltd.EKA2024-02-19
00840105207481ZOLL-DENTALZoll-DentalEKA2021-03-10
00840105207498ZOLL-DENTALZoll-DentalEKA2021-03-10
00840105207504ZOLL-DENTALZoll-DentalEKA2021-03-10
00840105207511ZOLL-DENTALZoll-DentalEKA2021-03-10
00840105207528ZOLL-DENTALZoll-DentalEKA2021-03-10
00840105207535ZOLL-DENTALZoll-DentalEKA2021-03-10
00840105207542ZOLL-DENTALZoll-DentalEKA2021-03-10
10889950004293HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKA2020-11-12
10889950004316HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKA2020-11-12
10889950041427HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKA2020-11-12
10889950123673HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKA2020-11-12
10889950004309HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKA2020-11-12