Two Stage Bone Level Dental Implant 4010 ENGAGE

GUDID D7854010ENGAGE0

Two Stage Bone Level Dental Implant: 4.0mm Diameter X 10mm length

OCO BIOMEDICAL INC

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• Primary Device ID: D7854010ENGAGE0
• NIH Device Record Key: dea2b031-aa36-4523-a473-9bcf3cb641ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Two Stage Bone Level Dental Implant
• Version Model Number: Engage
• Catalog Number: 4010 ENGAGE
• Company DUNS: 094146123
• Company Name: OCO BIOMEDICAL INC
• 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: true
• 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
HIBCC	D7854010ENGAGE0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090174

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-03-14

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