3.0 O-Ball Dental Implant 3016 OB

GUDID D7853016OB0

3.0 O-Ball Dental Implant: 3.0mm Diameter X 16mm Length

OCO BIOMEDICAL INC

Screw endosteal dental implant, one-piece

• Primary Device ID: D7853016OB0
• NIH Device Record Key: e0cc341a-7855-4334-9840-7b383cd493b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3.0 O-Ball Dental Implant
• Version Model Number: 3.0 O-Ball
• Catalog Number: 3016 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	D7853016OB0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080115

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

On-Brand Devices [3.0 O-Ball Dental Implant]

• D7853016OB0: 3.0 O-Ball Dental Implant: 3.0mm Diameter X 16mm Length
• D7853012OB0: 3.0 O-Ball Dental Implant: 3.0mm Diameter X 12mm Length
• D7853010OB0: 3.0 O-Ball Dental Implant: 3.0mm Diameter X 10mm Length
• D7853008OB0: 3.0 O-Ball Dental Implant: 3.0mm Diameter X 8mm Length