Link Abutment for CEREC

GUDID 08800000965406

Osstem Implant Co., Ltd.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08800000965406
• NIH Device Record Key: a2a615dc-c1c0-4ca0-9cf6-f38bb3900ec7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Link Abutment for CEREC
• Version Model Number: HGCTBMHW
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800000965406 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160519

FDA Product Code

• NHA: ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Sterilization

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

[08800000965406]

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: 2017-03-31

On-Brand Devices [Link Abutment for CEREC]

• 08800000965437: HGCTBRNW
• 08800000965420: HGCTBRHW
• 08800000965413: HGCTBMNW
• 08800000965406: HGCTBMHW