OSUNG MND

Primary DI
08800075622396
Brand
OSUNG MND
Company
OSUNG MND Co., Ltd.
Model
WLG1
Device description
A device designed to be used during the planning and post-osteotomy stages of a dental implantation procedure, prior to surgical implant placement/fixation, to measure/determine various lengths (e.g., drill depth of the osteotomy cavity, mucosal height, distance between implants/teeth for determining the mesiodistal position of the implant) and/or angles [e.g., direction of the perforation in relation to the antagonist arch], typically to help select an appropriate final prosthetic abutment to be installed. It is typically graduated and may be a hand-held instrument or a stand-alone device placed intraorally; some types are intended for use during x-ray imaging. This is a reusable device.
Published
2024-03-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EILGauge, Depth, Instrument, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EILGauge, Depth, Instrument, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800075622396PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800075622396088000756223968800075622396

GMDN Terms#

Term, Definition table
TermDefinition
Dental implantation depth/angle gauge, reusableA device designed to be used during the planning and post-osteotomy stages of a dental implantation procedure, prior to surgical implant placement/fixation, to measure/determine various lengths (e.g., drill depth of the osteotomy cavity, mucosal height, distance between implants/teeth for determining the mesiodistal position of the implant) and/or angles [e.g., direction of the perforation in relation to the antagonist arch], typically to help select an appropriate final prosthetic abutment to be installed. It is typically graduated and may be a hand-held instrument or a stand-alone device placed intraorally; some types are intended for use during x-ray imaging. 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

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