SDI Crown and Bridge Abutments (Ti) SDI 2.2/2.5 CB (Ti)

GUDID D785SDI2225CBTI0

2.2/2.5MM SDI C&B ABUTMENT

OCO BIOMEDICAL INC

Dental implant suprastructure, permanent, preformed

• Primary Device ID: D785SDI2225CBTI0
• NIH Device Record Key: bc1a8b25-f33d-4de6-9a9b-48ffb2780858
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SDI Crown and Bridge Abutments (Ti)
• Version Model Number: 2.2/2.5MM SDI C&B ABUTMENT
• Catalog Number: SDI 2.2/2.5 CB (Ti)
• 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: false
• 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	D785SDI2225CBTI0 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-08
• Device Publish Date: 2024-06-28

On-Brand Devices [SDI Crown and Bridge Abutments (Ti)]

• D785SDI2225CBTI0: 2.2/2.5MM SDI C&B ABUTMENT
• D785293325CBTI0: 2.9/3/3.25MM CONVERT OB TO CB ABUTMENT (TITANIUM)