FDA.reportPublic FDA data

OSUNG MND

Primary DI
08800075621320
Brand
OSUNG MND
Company
OSUNG MND Co., Ltd.
Model
RDSET
Device description
A collection of devices used to apply and remove a rubber dam, which is created chairside and placed over the crown of a patient's tooth or teeth in order to eliminate saliva or to prevent the patient swallowing liquid/dental material during dental surgery. It typically consists of rubber dam material, clamps, forceps, punch, frame, and tray. 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

Product Codes#

Code, Name table
CodeName
EEFClamp, Rubber Dam

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EEFClamp, Rubber DamDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800075621320PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800075621320088000756213208800075621320

GMDN Terms#

Term, Definition table
TermDefinition
Rubber dam kitA collection of devices used to apply and remove a rubber dam, which is created chairside and placed over the crown of a patient's tooth or teeth in order to eliminate saliva or to prevent the patient swallowing liquid/dental material during dental surgery. It typically consists of rubber dam material, clamps, forceps, punch, frame, and tray. 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
G879RDC000DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC12A0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC12AB0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC13A0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC13AB0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC140DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC14A0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC20DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC2000DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC2010DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC201B0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC2020DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC202B0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC2030DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC2040DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC2050DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC2060DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC206B0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC2070DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC207B0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC2080DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC2090DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC2100DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC210B0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC2110DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC211B0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC2120DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC240DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC24B0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC250DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22