Implant Mini

GUDID 06947600310044

BIO CONCEPT CO.,LTD

Dental implant system

• Primary Device ID: 06947600310044
• NIH Device Record Key: 4ad35ea2-a854-425a-889e-3b2a2e5d909c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Implant Mini
• Version Model Number: 311040
• 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	06947600310044 [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: 2020-07-17
• Device Publish Date: 2020-07-09

On-Brand Devices [Implant Mini]

• 06947600310051: 311050
• 06947600310044: 311040
• 06947600310037: 311030
• 06947600310020: 311020
• 06947600310013: 311010