Bone Level Implant Profile drill

GUDID 06947600306481

BIO CONCEPT CO.,LTD

Dental implant system

• Primary Device ID: 06947600306481
• NIH Device Record Key: 5fdb63a9-7547-4f1d-a3e7-6569988b0035
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bone Level Implant Profile drill
• Version Model Number: 150080
• 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06947600306481 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150388

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

[06947600306481]

Moist Heat or Steam Sterilization

[06947600306481]

Moist Heat or Steam Sterilization

[06947600306481]

Moist Heat or Steam Sterilization

[06947600306481]

Moist Heat or Steam Sterilization

[06947600306481]

Moist Heat or Steam Sterilization

[06947600306481]

Moist Heat or Steam Sterilization

[06947600306481]

Moist Heat or Steam Sterilization

[06947600306481]

Moist Heat or Steam Sterilization

[06947600306481]

Moist Heat or Steam Sterilization

[06947600306481]

Moist Heat or Steam Sterilization

[06947600306481]

Moist Heat or Steam Sterilization

[06947600306481]

Moist Heat or Steam Sterilization

[06947600306481]

Moist Heat or Steam Sterilization

[06947600306481]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-11-19
• Device Publish Date: 2016-09-01

On-Brand Devices [Bone Level Implant Profile drill]

• 06947600306528: 150120
• 06947600306511: 150110
• 06947600306498: 150090
• 06947600306481: 150080
• 06947600306467: 150060
• 06947600306450: 150050