GS III System

GUDID 08800040630234

Osstem Implant Co., Ltd.

Screw endosteal dental implant, two-piece

• Primary Device ID: 08800040630234
• NIH Device Record Key: 439fc0b4-8548-41d3-8032-4002ac0a9ea0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GS III System
• Version Model Number: GS3S5010R
• 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	08800040630234 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091208

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

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: 2022-12-06
• Device Publish Date: 2022-11-28

Devices Manufactured by Osstem Implant Co., Ltd.

• 08800271219987 - Bone Compaction KIT: 2024-10-04
• 08800271219994 - Bone Compaction KIT: 2024-10-04
• 08800271220013 - Bone Compaction Drill: 2024-10-04
• 08800271220020 - Bone Compaction Drill: 2024-10-04
• 08800271220037 - Bone Compaction Drill: 2024-10-04
• 08800271220044 - Bone Compaction Drill: 2024-10-04
• 08800271220051 - Bone Compaction Drill: 2024-10-04
• 08800271220068 - Bone Compaction Drill: 2024-10-04