Standard Implant

GUDID 06947600300366

BIO CONCEPT CO.,LTD

Dental implant system

• Primary Device ID: 06947600300366
• NIH Device Record Key: 59c33d5c-0cc5-4269-81df-d85bc03bf3fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Standard Implant
• Version Model Number: 013140
• 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	06947600300366 [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 [Standard Implant]

• 06947600300427: 013200
• 06947600300410: 013190
• 06947600300403: 013180
• 06947600300380: 013160
• 06947600300373: 013150
• 06947600300366: 013140
• 06947600300359: 013130
• 06947600300335: 013110
• 06947600300328: 013100
• 06947600300311: 013090
• 06947600300304: 013080
• 06947600300298: 013070
• 06947600300274: 013050
• 06947600300267: 013040
• 06947600300250: 013030
• 06947600300243: 013020
• 06947600300236: 013010