Bone Screw

GUDID 08800040644095

Osstem Implant Co., Ltd.

Screw endosteal dental implant, one-piece

• Primary Device ID: 08800040644095
• NIH Device Record Key: 8775a1cb-d6a7-4543-ae3b-20333d4174cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bone Screw
• Version Model Number: BSCH1203
• Company DUNS: 689051793
• Company Name: Osstem Implant Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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	08800040644095 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K251569

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]

• 08800040644132: BSCH1205
• 08800040644118: BSCH1204
• 08800040644095: BSCH1203