Hiossen Prosthetic System

GUDID 08809892359027

Osstem Implant Co., Ltd.

Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08809892359027
• NIH Device Record Key: c62351ed-7405-4422-aa8b-d68dd37d750b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hiossen Prosthetic System
• Version Model Number: MGW100TH
• 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	08809892359027 [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

[08809892359027]

Moist Heat or Steam Sterilization

[08809892359027]

Moist Heat or Steam Sterilization

[08809892359027]

Moist Heat or Steam Sterilization

[08809892359027]

Moist Heat or Steam Sterilization

[08809892359027]

Moist Heat or Steam Sterilization

[08809892359027]

Moist Heat or Steam Sterilization

[08809892359027]

Moist Heat or Steam Sterilization

[08809892359027]

Moist Heat or Steam Sterilization

[08809892359027]

Moist Heat or Steam Sterilization

[08809892359027]

Moist Heat or Steam Sterilization

[08809892359027]

Moist Heat or Steam Sterilization

[08809892359027]

Moist Heat or Steam Sterilization

[08809892359027]

Moist Heat or Steam Sterilization

[08809892359027]

Moist Heat or Steam Sterilization

[08809892359027]

Moist Heat or Steam Sterilization

[08809892359027]

Moist Heat or Steam Sterilization

[08809892359027]

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