Implant, Regular, Φ6.0mm, L15mm

GUDID 06947600313847

BIO CONCEPT Co., Ltd.

Dental implant system

• Primary Device ID: 06947600313847
• NIH Device Record Key: bb3035fe-06ee-4279-85c5-a15846d1b876
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Implant, Regular, Φ6.0mm, L15mm
• Version Model Number: 315070
• Company DUNS: 527603266
• Company Name: BIO CONCEPT 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: false
• 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	06947600313847 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192274

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: 2025-03-28
• Device Publish Date: 2025-03-20

Devices Manufactured by BIO CONCEPT Co., Ltd.

• 06936616987739 - Dome Drill,Φ5.5mm, L25mm: 2025-04-02
• 06936616987746 - Dome Drill,Φ7.0mm, L25mm: 2025-04-02
• 06936616987753 - Dome Drill,Φ7.0mm, L26mm: 2025-04-02
• 06936616987760 - Osteotome maxillary sinus elevation Drill,Φ2.8mm, L31mm: 2025-04-02
• 06936616987777 - Osteotome maxillary sinus elevation Drill,Φ2.8mm, L37mm: 2025-04-02
• 06936616987784 - Osteotome maxillary sinus elevation Drill,Φ3.1mm, L31mm: 2025-04-02
• 06936616987791 - Osteotome maxillary sinus elevation Drill,Φ3.1mm, L37mm: 2025-04-02
• 06936616987807 - Osteotome maxillary sinus elevation Drill,Φ3.3mm, L31mm: 2025-04-02