FDA.reportPublic FDA data

MOUNT EXTENSION

Primary DI
08800020861290
Brand
MOUNT EXTENSION
Company
SNUCONE Co.,LTD.
Model
GME
Published
2026-05-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800020861290PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800020861290088000208612908800020861290

GMDN Terms#

Term, Definition table
TermDefinition
Dental drill bit extensionA device intended to be attached to the shaft of a normal dental drill bit in order to lengthen it, providing greater accessibility and/or drilling capacity during a dental procedure. It is typically made of a high-grade metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
9999999999snucone@naver.com

Regulatory Flags#

DUNS number
688806132
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
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800020807151SNUCONE TISSUE LEVEL IMPLANT SYSTEMEIOA-4810-72026-09-22
08800020807168SNUCONE TISSUE LEVEL IMPLANT SYSTEMEIOA-4820-72026-09-22
08800020807175SNUCONE TISSUE LEVEL IMPLANT SYSTEMEIOA-4830-72026-09-22
08800020807182SNUCONE TISSUE LEVEL IMPLANT SYSTEMEIOA-4840-72026-09-22
08800020807199SNUCONE TISSUE LEVEL IMPLANT SYSTEMEIOA-6010-52026-09-22
08800020807205SNUCONE TISSUE LEVEL IMPLANT SYSTEMEIOA-6020-52026-09-22
08800020807212SNUCONE TISSUE LEVEL IMPLANT SYSTEMEIOA-6030-52026-09-22
08800020807229SNUCONE TISSUE LEVEL IMPLANT SYSTEMEIOA-6040-52026-09-22
08800020807236SNUCONE TISSUE LEVEL IMPLANT SYSTEMEIOA-6010-72026-09-22
08800020807243SNUCONE TISSUE LEVEL IMPLANT SYSTEMEIOA-6020-72026-09-22
08800020807250SNUCONE TISSUE LEVEL IMPLANT SYSTEMEIOA-6030-72026-09-22
08800020807267SNUCONE TISSUE LEVEL IMPLANT SYSTEMEIOA-6040-72026-09-22
08800020807311SNUCONE TISSUE LEVEL IMPLANT SYSTEMEINA-4810-72026-09-22
08800020807328SNUCONE TISSUE LEVEL IMPLANT SYSTEMEINA-4820-72026-09-22
08800020807335SNUCONE TISSUE LEVEL IMPLANT SYSTEMEINA-4830-72026-09-22
08800020807342SNUCONE TISSUE LEVEL IMPLANT SYSTEMEINA-4840-72026-09-22
08800020807359SNUCONE TISSUE LEVEL IMPLANT SYSTEMEINA-6010-52026-09-22
08800020807366SNUCONE TISSUE LEVEL IMPLANT SYSTEMEINA-6020-52026-09-22
08800020807373SNUCONE TISSUE LEVEL IMPLANT SYSTEMEINA-6030-52026-09-22
08800020807380SNUCONE TISSUE LEVEL IMPLANT SYSTEMEINA-6040-52026-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03701045246398KONTACTBIOTECH DENTALNDP2026-10-26
03701045279471KONTACTBIOTECH DENTALNDP2026-10-26
03701045279488KONTACTBIOTECH DENTALNDP2026-10-26
03701045279495KONTACTBIOTECH DENTALNDP2026-10-26
03701045279501KONTACTBIOTECH DENTALNDP2026-10-26
03701045279518KONTACTBIOTECH DENTALNDP2026-10-26
03701045279525KONTACTBIOTECH DENTALNDP2026-10-26
03701045279532KONTACTBIOTECH DENTALNDP2026-10-26
03701045279549KONTACTBIOTECH DENTALNDP2026-10-26
03701045279556KONTACTBIOTECH DENTALNDP2026-10-26
03701045279563KONTACTBIOTECH DENTALNDP2026-10-26
03701045279570KONTACTBIOTECH DENTALNDP2026-10-26
03701045279587KONTACTBIOTECH DENTALNDP2026-10-26
03701045279594KONTACTBIOTECH DENTALNDP2026-10-26
03701045279600KONTACTBIOTECH DENTALNDP2026-10-26
03701045279617KONTACTBIOTECH DENTALNDP2026-10-26
03701045279624KONTACTBIOTECH DENTALNDP2026-10-26
03701045279631KONTACTBIOTECH DENTALNDP2026-10-26
03701045279648KONTACTBIOTECH DENTALNDP2026-10-26
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