Bone Level Tapered Implant

GUDID 06947600303046

BIO CONCEPT CO.,LTD

Dental implant system

• Primary Device ID: 06947600303046
• NIH Device Record Key: 7352bd15-3ac7-40c9-96cb-2dcef2797b1a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bone Level Tapered Implant
• Version Model Number: 115010
• 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	06947600303046 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212364

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: 2022-09-08
• Device Publish Date: 2022-08-31

On-Brand Devices [Bone Level Tapered Implant]

• 06947600303213: 117060
• 06947600303206: 117050
• 06947600303190: 117040
• 06947600303183: 117030
• 06947600303176: 117020
• 06947600303169: 117010
• 06947600303152: 116060
• 06947600303145: 116050
• 06947600303138: 116040
• 06947600303121: 116030
• 06947600303114: 116020
• 06947600303107: 116010
• 06947600303091: 115060
• 06947600303084: 115050
• 06947600303077: 115040
• 06947600303060: 115030
• 06947600303053: 115020
• 06947600303046: 115010