Bone Screw, Bone Tack

GUDID 08800000987354

Osstem Implant Co., Ltd.

Screw endosteal dental implant, one-piece

• Primary Device ID: 08800000987354
• NIH Device Record Key: 4cd03bbb-5726-4b93-b69a-07b5bdc53ba8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bone Screw, Bone Tack
• Version Model Number: BSCH2014
• 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: true
• 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	08800000987354 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182881

FDA Product Code

• DZL: Screw, Fixation, Intraosseous

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-17
• Device Publish Date: 2026-03-09

On-Brand Devices [Bone Screw, Bone Tack]

• 08800040654599: OBT3
• 08800000987361: BSCH2016
• 08800000987354: BSCH2014
• 08800000987347: BSCH2012
• 08800000987330: BSCH2010
• 08800000987323: BSCH2008
• 08800000987316: BSCH1408
• 08800000987309: BSCH1406
• 08800000987293: BSCH1404