Multi Angled Abutment system

GUDID 08800000925349

Osstem Implant Co., Ltd.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08800000925349
• NIH Device Record Key: 99195746-a57b-47d8-a9a3-185f9dd0c94a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Multi Angled Abutment system
• Version Model Number: HGMAA317MHW
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800000925349 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132067

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08800000925349]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-08
• Device Publish Date: 2015-10-16

On-Brand Devices [Multi Angled Abutment system]

• 08800000925370: HGMATSM
• 08800000925363: HGMATSS
• 08800000925356: HGMAA217MHW
• 08800000925349: HGMAA317MHW
• 08800000925332: HGMAA417MHW
• 08800000925325: HGMAA330MHW
• 08800000925318: HGMAA430MHW
• 08800000925301: HGMAA530MHW
• 08800000925295: HGMAA217SHW
• 08800000925288: HGMAA317SHW
• 08800000925271: HGMAA417SHW
• 08800000925264: HGMAA330SHW
• 08800000925257: HGMAA430SHW
• 08800000925240: HGMAA530SHW