HEALING ABUTMENT SLIM 4035-5HA (SLIM)

GUDID D78540355HASLIM0

(SLIM) 4.0mm ENGAGE HEALING ABUTMENT 3.5MM PLATFORM, 5MM LENGTH

OCO BIOMEDICAL INC

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: D78540355HASLIM0
• NIH Device Record Key: a1b2da4a-713b-4cb5-a2ff-61e6945f6947
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HEALING ABUTMENT SLIM
• Version Model Number: 4.0mm ENGAGE HEALING ABUTMENT 3.5MM PLATFORM, 5MM
• Catalog Number: 4035-5HA (SLIM)
• 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	D78540355HASLIM0 [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

[D78540355HASLIM0]

Moist Heat or Steam Sterilization

[D78540355HASLIM0]

Moist Heat or Steam Sterilization

[D78540355HASLIM0]

Moist Heat or Steam Sterilization

[D78540355HASLIM0]

Moist Heat or Steam Sterilization

[D78540355HASLIM0]

Moist Heat or Steam Sterilization

[D78540355HASLIM0]

Moist Heat or Steam Sterilization

[D78540355HASLIM0]

Moist Heat or Steam Sterilization

[D78540355HASLIM0]

Moist Heat or Steam Sterilization

[D78540355HASLIM0]

Moist Heat or Steam Sterilization

[D78540355HASLIM0]

Moist Heat or Steam Sterilization

[D78540355HASLIM0]

Moist Heat or Steam Sterilization

[D78540355HASLIM0]

Moist Heat or Steam Sterilization

[D78540355HASLIM0]

Moist Heat or Steam Sterilization

[D78540355HASLIM0]

Moist Heat or Steam Sterilization

[D78540355HASLIM0]

Moist Heat or Steam Sterilization

[D78540355HASLIM0]

Moist Heat or Steam Sterilization

[D78540355HASLIM0]

Moist Heat or Steam Sterilization

[D78540355HASLIM0]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-22
• Device Publish Date: 2024-02-14

On-Brand Devices [HEALING ABUTMENT SLIM]

• D78540355HASLIM0: (SLIM) 4.0mm ENGAGE HEALING ABUTMENT 3.5MM PLATFORM, 5MM LENGTH
• D78540353HASLIM0: (SLIM) 4.0mm ENGAGE HEALING ABUTMENT 3.5MM PLATFORM, 3MM LENGTH
• D78550455HASLIM0: (SLIM) 5.0MM ENGAGE HEALING ABUTMENT 4.5MM PLATFORM, 5MM LENGTH
• D78550453HASLIM0: (SLIM) 5.0MM ENGAGE HEALING ABUTMENT 4.5MM PLATFORM, 3MM LENGTH
• D78560575HASLIM0: (SLIM) 6.0MM ENGAGE HEALING ABUTMENT 5.7MM PLATFORM, 5MM LENGTH
• D78560573HASLIM0: (SLIM) 6.0MM ENGAGE HEALING ABUTMENT 5.7MM PLATFORM, 3MM LENGTH