One Piece O-Ball Dental Implant ISI 4008 OB

GUDID D785ISI4008OB0

One Piece O-Ball Dental Implant: 4.0mm Diameter X 8mm length

OCO BIOMEDICAL INC

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• Primary Device ID: D785ISI4008OB0
• NIH Device Record Key: 39a041e6-47c7-4937-95c2-7f9cb85688dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: One Piece O-Ball Dental Implant
• Version Model Number: O-Ball
• Catalog Number: ISI 4008 OB
• 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	D785ISI4008OB0 [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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• D785ISI4014OB0: One Piece O-Ball Dental Implant: 4.0mm Diameter X 14mm length
• D785ISI4012OB0: One Piece O-Ball Dental Implant: 4.0mm Diameter X 12mm length
• D785ISI4010OB0: One Piece O-Ball Dental Implant: 4.0mm Diameter X 10mm Length
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• D785ISI32516OB0: One Piece O-Ball Dental Implant: 3.25mm Diameter X 16mm Length
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