FLUSH HEALING SCREW 5.0 FLUSH HS

GUDID D78550FLUSHHS0

5.0mm FLUSH HEALING SCREW

OCO BIOMEDICAL INC

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: D78550FLUSHHS0
• NIH Device Record Key: 1e05212d-92ca-4b63-a2be-a5ff03c626b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FLUSH HEALING SCREW
• Version Model Number: 5.0mm FLUSH HEALING SCREW
• Catalog Number: 5.0 FLUSH HS
• 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	D78550FLUSHHS0 [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

[D78550FLUSHHS0]

Moist Heat or Steam Sterilization

[D78550FLUSHHS0]

Moist Heat or Steam Sterilization

[D78550FLUSHHS0]

Moist Heat or Steam Sterilization

[D78550FLUSHHS0]

Moist Heat or Steam Sterilization

[D78550FLUSHHS0]

Moist Heat or Steam Sterilization

[D78550FLUSHHS0]

Moist Heat or Steam Sterilization

[D78550FLUSHHS0]

Moist Heat or Steam Sterilization

[D78550FLUSHHS0]

Moist Heat or Steam Sterilization

[D78550FLUSHHS0]

Moist Heat or Steam Sterilization

[D78550FLUSHHS0]

Moist Heat or Steam Sterilization

[D78550FLUSHHS0]

Moist Heat or Steam Sterilization

[D78550FLUSHHS0]

Moist Heat or Steam Sterilization

[D78550FLUSHHS0]

Moist Heat or Steam Sterilization

[D78550FLUSHHS0]

Moist Heat or Steam Sterilization

[D78550FLUSHHS0]

Moist Heat or Steam Sterilization

[D78550FLUSHHS0]

Moist Heat or Steam Sterilization

[D78550FLUSHHS0]

Moist Heat or Steam Sterilization

[D78550FLUSHHS0]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-23
• Device Publish Date: 2024-02-15

On-Brand Devices [FLUSH HEALING SCREW]

• D78550FLUSHHS0: 5.0mm FLUSH HEALING SCREW
• D785325FLUSHHS0: 3.25mm FLUSH HEALING SCREW