Bone Profiler 1

GUDID 06947600304463

BIO CONCEPT CO.,LTD

Dental implant system

• Primary Device ID: 06947600304463
• NIH Device Record Key: 4f2a01ab-6ad3-48a5-a55c-5101e46abd3f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bone Profiler 1
• Version Model Number: 151200
• 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: false
• Lot Batch: true
• Serial Number: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	06947600304463 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212364

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[06947600304463]

Moist Heat or Steam Sterilization

[06947600304463]

Moist Heat or Steam Sterilization

[06947600304463]

Moist Heat or Steam Sterilization

[06947600304463]

Moist Heat or Steam Sterilization

[06947600304463]

Moist Heat or Steam Sterilization

[06947600304463]

Moist Heat or Steam Sterilization

[06947600304463]

Moist Heat or Steam Sterilization

[06947600304463]

Moist Heat or Steam Sterilization

[06947600304463]

Moist Heat or Steam Sterilization

[06947600304463]

Moist Heat or Steam Sterilization

[06947600304463]

Moist Heat or Steam Sterilization

[06947600304463]

Moist Heat or Steam Sterilization

[06947600304463]

Moist Heat or Steam Sterilization

[06947600304463]

Moist Heat or Steam Sterilization

[06947600304463]

Moist Heat or Steam Sterilization

[06947600304463]

Moist Heat or Steam Sterilization

[06947600304463]

Moist Heat or Steam Sterilization

[06947600304463]

Moist Heat or Steam Sterilization

[06947600304463]

Moist Heat or Steam Sterilization

[06947600304463]

Moist Heat or Steam Sterilization

[06947600304463]

Moist Heat or Steam Sterilization

[06947600304463]

Moist Heat or Steam Sterilization

[06947600304463]

Moist Heat or Steam Sterilization

[06947600304463]

Moist Heat or Steam Sterilization

[06947600304463]

Moist Heat or Steam Sterilization

[06947600304463]

Moist Heat or Steam Sterilization

[06947600304463]

Moist Heat or Steam Sterilization

[06947600304463]

Moist Heat or Steam Sterilization

[06947600304463]

Moist Heat or Steam Sterilization

[06947600304463]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-13
• Device Publish Date: 2022-09-05

Devices Manufactured by BIO CONCEPT CO.,LTD

• 06947600309055 - Scanbody for screw-retained abutment: 2024-11-29
• 06947600309079 - Scanbody for screw-retained abutment: 2024-11-29
• 06947600309109 - BLNC Digital Analog: 2024-11-29
• 06947600309116 - BLRC Digital Analog: 2024-11-29
• 06947600309123 - TLRN Digital Analog: 2024-11-29
• 06947600309130 - TLWN Digital Analog: 2024-11-29
• 06947600309147 - BL3.5 Screw-retained Abutment Digital Analog: 2024-11-29
• 06947600309154 - BL4.6 Screw-retained Abutment Digital Analog: 2024-11-29