Fixture Pick-up Impression Coping,Regular

GUDID 06947600314264

BIO CONCEPT CO.,LTD

Dental implant system

• Primary Device ID: 06947600314264
• NIH Device Record Key: 0c8fab8f-a308-4e81-8b8b-40d05da2ddd3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fixture Pick-up Impression Coping,Regular
• Version Model Number: 362240
• 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: 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	06947600314264 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192274

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-20
• Device Publish Date: 2020-07-10

On-Brand Devices [Fixture Pick-up Impression Coping,Regular]

• 06947600314288: 362260
• 06947600314271: 362250
• 06947600314264: 362240
• 06947600314257: 362230
• 06947600314240: 362220
• 06947600314233: 362210
• 06947600312437: 362520
• 06947600312420: 362510
• 06947600312413: 362500
• 06947600312345: 362490