Small Diameter Dental Implant SDI 2914 OB

GUDID D785SDI2914OB0

Small Diameter Dental Implant: 2.9mm Diameter X 14mm Length

OCO BIOMEDICAL INC

Screw endosteal dental implant, one-piece

• Primary Device ID: D785SDI2914OB0
• NIH Device Record Key: 4a3630cb-120b-4443-bce9-4f8d300a0541
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Small Diameter Dental Implant
• Version Model Number: SDI O-Ball
• Catalog Number: SDI 2914 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D785SDI2914OB0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011524

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: 2016-03-17

On-Brand Devices [Small Diameter Dental Implant]

• D785SDI2916OB0: Small Diameter Dental Implant: 2.9mm Diameter X 16mm length
• D785SDI2916CB0: Small Diameter Dental Implant: 2.9mm Diameter X 16mm Length
• D785SDI2914OB0: Small Diameter Dental Implant: 2.9mm Diameter X 14mm Length
• D785SDI2914CB0: Small Diameter Dental Implant: 2.9mm Diameter X 14mm Length
• D785SDI2912OB0: Small Diameter Dental Implant: 2.9mm Diameter X 12mm Length
• D785SDI2912CB0: Small Diameter Dental Implant: 2.9mm Diameter X 12mm Length
• D785SDI2910OB0: Small Diameter Dental Implant: 2.9mm Diameter X 10mm Length
• D785SDI2910CB0: Small Diameter Dental Implant: 2.9mm Diameter X 10mm Length
• D785SDI2908OB0: Small Diameter Dental Implant: 2.9mm Diameter X 8mm Length
• D785SDI2908CB0: Small Diameter Dental Implant: 2.9mm Diameter X 8mm Length
• D785SDI2516OB0: Small Diameter Dental Implant : 2.5mm Diameter X 16mm Length
• D785SDI2516CB0: Small Diameter Dental Implant: 2.5mm Diameter X 16mm Length
• D785SDI2514OB0: Small Diameter Dental Implant: 2.5mm Diameter X 14mm Length
• D785SDI2514CB0: Small Diameter Dental Implant: 2.5mm Diameter X 14mm Length
• D785SDI2512OB0: Small Diameter Dental Implant: 2.5mm Diameter X 12mm Length
• D785SDI2512CB0: Small Diameter Dental Implant: 2.5mm Diameter X 12mm Length
• D785SDI2510OB0: Small Diameter Dental Implant: 2.5mm Diameter X 10mm Length
• D785SDI2510CB0: Small Diameter Dental Implant: 2.5mm Diameter X 10mm Length
• D785SDI2216OB0: Small Diameter Dental Implant: 2.2mm Diameter X 16mm Length
• D785SDI2216CB0: Small Diameter Dental Implant: 2.2mm Diameter X 16mm Length
• D785SDI2214OB0: Small Diameter Dental Implant: 2.2mm Diameter X 14mm Length
• D785SDI2214CB0: Small Diameter Dental Implant: 2.2mm Diameter X 14mm Length
• D785SDI2212OB0: Small Diameter Dental Implant: 2.2mm Diameter X 12mm length
• D785SDI2212CB0: Small Diameter Dental Implant: 2.2mm Diameter X 12mm Length
• D785SDI2210OB0: Small Diameter Dental Implant: 2.2mm Diameter X 10mm Length
• D785SDI2210CB0: Small Diameter Implant: 2.2mm Diameter X 10mm Length