Round bur

GUDID 06947600301431

BIO CONCEPT CO.,LTD

Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system 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