Two Stage Bone Level Implant 32508 Engage Plus

GUDID D78532508ENGPLS0

3.25mm diameter X 8mm length Engage Plus Bone Level Implant

OCO BIOMEDICAL INC

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• Primary Device ID: D78532508ENGPLS0
• NIH Device Record Key: 06b72b9c-bd29-4542-95c7-dd428a9095ca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Two Stage Bone Level Implant
• Version Model Number: EngagePlus
• Catalog Number: 32508 Engage Plus
• 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
ICCBBA	D78532508ENGPLS0 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-10
• Device Publish Date: 2019-10-02

On-Brand Devices [Two Stage Bone Level Implant]

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• D7856010ENGPLS0: 6mm diameter X 10mm length Bone Level Implant
• D7856008ENGPLS0: 6mm diameter X 8mm length Bone Level Implant
• D7855016ENGPLS0: 5mm diameter X 16mm length Bone Level Implant
• D7855014ENGPLS0: 5mm diameter X 14mm length Bone Level Implant
• D7855012ENGPLS0: 5mm diameter X 12mm length Bone Level Implant
• D7855010ENGPLS0: 5mm diameter X 10mm length Bone Level Implant
• D7855008ENGPLS0: 5mm diameter X 8mm length Bone Level Implant
• D7854016ENGPLS0: 4mm diameter X 16mm length Bone Level Implant
• D7854014ENGPLS0: 4mm diameter X 14mm length Bone Level Implant
• D7854012ENGPLS0: 4mm diameter X 12mm length Bone Level Implant
• D7854010ENGPLS0: 4mm diameter X 10mm length Bone Level Implant
• D7854008ENGPLS0: 4mm diameter X 8mm length Bone Level Implant
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• D78532514ENGPLS0: 3.25mm diameter X 14mm length Bone Level Implant
• D78532512ENGPLS0: 3.25mm diameter X 12mm length Bone Level Implant
• D78532510ENGPLS0: 3.25mm diameter X 10mm length Engage Plus Bone Level Implant
• D78532508ENGPLS0: 3.25mm diameter X 8mm length Engage Plus Bone Level Implant