Hiossen Prosthetic System

GUDID 08809892358983

Osstem Implant Co., Ltd.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08809892358983
• NIH Device Record Key: 9b77ba97-a810-4a6d-b5d0-909efd39311b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hiossen Prosthetic System
• Version Model Number: MGR100TH
• Company DUNS: 689051793
• Company Name: Osstem Implant Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(821)012-3412
• Email: chicson@osstem.com
• Phone: +1(821)012-3412
• Email: chicson@osstem.com
• Phone: +1(821)012-3412
• Email: chicson@osstem.com
• Phone: +1(821)012-3412
• Email: chicson@osstem.com
• Phone: +1(821)012-3412
• Email: chicson@osstem.com
• Phone: +1(821)012-3412
• Email: chicson@osstem.com
• Phone: +1(821)012-3412
• Email: chicson@osstem.com
• Phone: +1(821)012-3412
• Email: chicson@osstem.com
• Phone: +1(821)012-3412
• Email: chicson@osstem.com
• Phone: +1(821)012-3412
• Email: chicson@osstem.com
• Phone: +1(821)012-3412
• Email: chicson@osstem.com
• Phone: +1(821)012-3412
• Email: chicson@osstem.com
• Phone: +1(821)012-3412
• Email: chicson@osstem.com
• Phone: +1(821)012-3412
• Email: chicson@osstem.com
• Phone: +1(821)012-3412
• Email: chicson@osstem.com
• Phone: +1(821)012-3412
• Email: chicson@osstem.com
• Phone: +1(821)012-3412
• Email: chicson@osstem.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809892358983 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140507

FDA Product Code

• NHA: Abutment, implant, dental, endosseous

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[08809892358983]

Moist Heat or Steam Sterilization

[08809892358983]

Moist Heat or Steam Sterilization

[08809892358983]

Moist Heat or Steam Sterilization

[08809892358983]

Moist Heat or Steam Sterilization

[08809892358983]

Moist Heat or Steam Sterilization

[08809892358983]

Moist Heat or Steam Sterilization

[08809892358983]

Moist Heat or Steam Sterilization

[08809892358983]

Moist Heat or Steam Sterilization

[08809892358983]

Moist Heat or Steam Sterilization

[08809892358983]

Moist Heat or Steam Sterilization

[08809892358983]

Moist Heat or Steam Sterilization

[08809892358983]

Moist Heat or Steam Sterilization

[08809892358983]

Moist Heat or Steam Sterilization

[08809892358983]

Moist Heat or Steam Sterilization

[08809892358983]

Moist Heat or Steam Sterilization

[08809892358983]

Moist Heat or Steam Sterilization

[08809892358983]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-13
• Device Publish Date: 2023-11-04

On-Brand Devices [Hiossen Prosthetic System]

• 08800000963327: OAON01S
• 08800000925608: ETHLAP5M
• 08800000925592: ETHLAP7M
• 08800000925585: ETHLAP9M
• 08800000925578: ETHLAP5R
• 08800000925561: ETHLAP7R
• 08800000925554: ETHLAP9R
• 08800000925547: GSCHABSMT
• 08800000925530: GSCHABSST
• 08800000925523: HGNCA401MHW
• 08800000925516: HGNCA403MHW
• 08800000925509: HGNCA401MNW
• 08800000925493: HGNCA403MNW
• 08800000925486: HGNCA451SHW
• 08800000925479: HGNCA453SHW
• 08800000925462: HGNCA451SNW
• 08800000925455: HGNCA453SNW
• 08800000925448: ORN1C
• 08800000925431: ORN1R
• 08800000925424: ORN1
• 08800000925417: MGR100TH
• 08800000925400: MGW100TH
• 08800000925394: MGR200TH
• 08800000925387: MGW200TH
• 08809892359041: MGW200TH
• 08809892359027: MGW100TH
• 08809892359003: MGR200TH
• 08809892358983: MGR100TH