MULTI UNIT TEMP MU TEMP

GUDID D785MUTEMP0

MULTI-UNIT TITANIUM TEMPORARY (Includes prosthetic screw)

OCO BIOMEDICAL INC

Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: D785MUTEMP0
• NIH Device Record Key: 69df282f-3dc3-4dca-8d04-1f4e1f5f4501
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MULTI UNIT TEMP
• Version Model Number: MULTI-UNIT TITANIUM TEMPORARY INCLUDES PROSTHETIC
• Catalog Number: MU TEMP
• 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	D785MUTEMP0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090174

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[D785MUTEMP0]

Moist Heat or Steam Sterilization

[D785MUTEMP0]

Moist Heat or Steam Sterilization

[D785MUTEMP0]

Moist Heat or Steam Sterilization

[D785MUTEMP0]

Moist Heat or Steam Sterilization

[D785MUTEMP0]

Moist Heat or Steam Sterilization

[D785MUTEMP0]

Moist Heat or Steam Sterilization

[D785MUTEMP0]

Moist Heat or Steam Sterilization

[D785MUTEMP0]

Moist Heat or Steam Sterilization

[D785MUTEMP0]

Moist Heat or Steam Sterilization

[D785MUTEMP0]

Moist Heat or Steam Sterilization

[D785MUTEMP0]

Moist Heat or Steam Sterilization

[D785MUTEMP0]

Moist Heat or Steam Sterilization

[D785MUTEMP0]

Moist Heat or Steam Sterilization

[D785MUTEMP0]

Moist Heat or Steam Sterilization

[D785MUTEMP0]

Moist Heat or Steam Sterilization

[D785MUTEMP0]

Moist Heat or Steam Sterilization

[D785MUTEMP0]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-26
• Device Publish Date: 2024-02-16

Devices Manufactured by OCO BIOMEDICAL INC

• D785002CAPWOBN0 - HOUSING CAP WITH O-RING: 2024-07-04 002 CAP WITH O-RING INSERTED (002BN900)
• D785325SB0 - SCAN BODY: 2024-07-04 TSI/ERI 3.25MM SCAN BODY
• D78540SB0 - SCAN BODY: 2024-07-04 TSI/ERI 4.0MM SCAN BODY
• D78550SB0 - SCAN BODY: 2024-07-04 TSI/ERI 5.0MM SCAN BODY
• D78562000 - Complete Surgical Kit: 2024-07-04 Complete Surgical Kit Caddy
• D78562010 - Small Diameter Surgical Kit: 2024-07-04 Small Diameter Surgical Kit Caddy
• D78562020 - Osteotome Tray: 2024-07-04 Osteotome Tray
• D78562050 - Engage Compact Kit: 2024-07-04 Engage Compact Kit Case