Bone Level Implant

GUDID 06947600305118

BIO CONCEPT CO.,LTD

Dental implant system

• Primary Device ID: 06947600305118
• NIH Device Record Key: dc245009-20c6-4c16-9f92-b731c0def5f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bone Level Implant
• Version Model Number: 112020
• 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: true
• 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	06947600305118 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150388

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

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]

• 06947600305231: 113040
• 06947600305217: 113030
• 06947600305194: 113020
• 06947600305170: 113010
• 06947600305156: 112040
• 06947600305132: 112030
• 06947600305118: 112020
• 06947600305095: 112010
• 06947600305071: 111040
• 06947600305057: 111030
• 06947600305033: 111020
• 06947600305019: 111010