Round bur

GUDID 06947600301431

BIO CONCEPT CO.,LTD

Dental implant system

• Primary Device ID: 06947600301431
• NIH Device Record Key: dc45a8a9-43d0-4d7c-ac39-f0d3e1d1ef13
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Round bur
• Version Model Number: 051010
• 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	06947600301431 [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

[06947600301431]

Moist Heat or Steam Sterilization

[06947600301431]

Moist Heat or Steam Sterilization

[06947600301431]

Moist Heat or Steam Sterilization

[06947600301431]

Moist Heat or Steam Sterilization

[06947600301431]

Moist Heat or Steam Sterilization

[06947600301431]

Moist Heat or Steam Sterilization

[06947600301431]

Moist Heat or Steam Sterilization

[06947600301431]

Moist Heat or Steam Sterilization

[06947600301431]

Moist Heat or Steam Sterilization

[06947600301431]

Moist Heat or Steam Sterilization

[06947600301431]

Moist Heat or Steam Sterilization

[06947600301431]

Moist Heat or Steam Sterilization

[06947600301431]

Moist Heat or Steam Sterilization

[06947600301431]

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 [Round bur]

• 06947600301455: 051030
• 06947600301448: 051020
• 06947600301431: 051010