Tapered Effect Implant

GUDID 06947600300519

BIO CONCEPT CO.,LTD

Dental implant system

• Primary Device ID: 06947600300519
• NIH Device Record Key: 400c6f49-c3c1-4c15-9d88-4a1056e157f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tapered Effect Implant
• Version Model Number: 014090
• 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	06947600300519 [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 [Tapered Effect Implant]

• 06947600300533: 014110
• 06947600300526: 014100
• 06947600300519: 014090
• 06947600300502: 014080
• 06947600300496: 014070
• 06947600300489: 014060
• 06947600300472: 014050
• 06947600300465: 014040
• 06947600300458: 014030
• 06947600300441: 014020
• 06947600300434: 014010