NON ENGAGING WAXING SLEEVE 4TSI-NO

GUDID D7854TSINO0

4.0mm TSI OCTA WAXING SLEEVE W/ SCREW

OCO BIOMEDICAL INC

Dental implant suprastructure, permanent, preformed

• Primary Device ID: D7854TSINO0
• NIH Device Record Key: 99911fc5-7079-4e2c-8862-d3f77d0c2e08
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NON ENGAGING WAXING SLEEVE
• Version Model Number: 4.0mm TSI OCTA WAXING SLEEVE W/ SCREW
• Catalog Number: 4TSI-NO
• 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: false
• 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	D7854TSINO0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090174

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-07
• Device Publish Date: 2024-02-28

On-Brand Devices [NON ENGAGING WAXING SLEEVE]

• D7855TSINO0: 5.0mm TSI NON-OCTA WAXING SLEEVE W/ SCREW
• D7854TSINO0: 4.0mm TSI OCTA WAXING SLEEVE W/ SCREW