One Piece Crown & Bridge Dental Implant ISI 4008 CB

GUDID D785ISI4008CB0

One Piece Crown & Bridge Dental Implant: 4.0mm Diameter X 8mm Length

OCO BIOMEDICAL INC

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• Primary Device ID: D785ISI4008CB0
• NIH Device Record Key: 59fefcc6-2a98-423c-a0e6-b7e00810632c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: One Piece Crown & Bridge Dental Implant
• Version Model Number: Crown & Bridge
• Catalog Number: ISI 4008 CB
• 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	D785ISI4008CB0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033392

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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