Bone Level Implant Abutment 4035-4OB

GUDID D78540354OB0

4mm O-Ball Abutment 4mm Diameter 4mm Collar

OCO BIOMEDICAL INC

Dental implant system Dental implant system Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed

• Primary Device ID: D78540354OB0
• NIH Device Record Key: b780ccd6-4ad5-41f6-a3dd-2ec4a94c57cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bone Level Implant Abutment
• Version Model Number: 4mm O-Ball Abutment
• Catalog Number: 4035-4OB
• 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: true
• Manufacturing Date: false
• 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	D78540354OB0 [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

[D78540354OB0]

Moist Heat or Steam Sterilization

[D78540354OB0]

Moist Heat or Steam Sterilization

[D78540354OB0]

Moist Heat or Steam Sterilization

[D78540354OB0]

Moist Heat or Steam Sterilization

[D78540354OB0]

Moist Heat or Steam Sterilization

[D78540354OB0]

Moist Heat or Steam Sterilization

[D78540354OB0]

Moist Heat or Steam Sterilization

[D78540354OB0]

Moist Heat or Steam Sterilization

[D78540354OB0]

Moist Heat or Steam Sterilization

[D78540354OB0]

Moist Heat or Steam Sterilization

[D78540354OB0]

Moist Heat or Steam Sterilization

[D78540354OB0]

Moist Heat or Steam Sterilization

[D78540354OB0]

Moist Heat or Steam Sterilization

[D78540354OB0]

Moist Heat or Steam Sterilization

[D78540354OB0]

Moist Heat or Steam Sterilization

[D78540354OB0]

Moist Heat or Steam Sterilization

[D78540354OB0]

Moist Heat or Steam Sterilization

[D78540354OB0]

Moist Heat or Steam Sterilization

[D78540354OB0]

Moist Heat or Steam Sterilization

[D78540354OB0]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-04-11

On-Brand Devices [Bone Level Implant Abutment]

• D7856057PA0: 6mm Peek Temporary Straight Abutment 6mm Diameter
• D7856057CAA0: 6mm Custom Angled 15 Degree Abutment 6mm Diameter
• D78560573SA0: 6mm Straight Abutment 6mm Diameter 3mm Collar
• D78560572SA0: 6mm Straight Abutment 6mm Diameter 2mm Collar
• D78560572OB0: 6mm O-Ball Abutment 6mm Diameter 2mm Collar
• D78560572CB0: 6mm Crown & Bridge Abutment 6mm Diameter 2mm Collar For multiple unit restorations only (not fo
• D78560571SA0: 6mm Straight Abutment 6mm Diameter 1mm Collar
• D78560571OB0: 6mm O-Ball Abutment 6mm Diameter 1mm Collar
• D7855045PA0: 5mm PEEK Temporart Straight Abutment 5mm Diameter
• D7855045CAA0: 5mm Custom Angled 15 Degree Abutment 5mm Diameter
• D78550454OB0: 5mm O-Ball Abutment 5mm Diameter 4mm Collar
• D78550453SA0: 5mm Straight Abutment 5mm Diameter 3mm Collar
• D78550453OB0: 5mm O-Ball Abutment 5mm Diameter 3mm Collar
• D78550452SA0: 5mm Straight Abutment 5mm Diameter 2mm Collar
• D78550452OB0: 5mm O-Ball Abutment 5mm Diameter 2mm Collar
• D78550452CB0: 5mm Crown & Bridge Abutment 5mm Diameter 2mm Collar For multiple unit restorations only (not for
• D78550451SA0: 5mm Straight Abutment 5mm Diameter 1mm Collar
• D7854035PA0: 4mm PEEK Temporary Straight Abutment 4mm Diameter
• D7854035CAA0: 4mm Custom Angled 15 Degree Abutment 4mm Diameter
• D78540354OB0: 4mm O-Ball Abutment 4mm Diameter 4mm Collar
• D78540353SA0: 4mm Straight Abutment 4mm Diameter 3mm Collar
• D78540353OB0: 4mm O-Ball Abutment 4mm Diameter 3mm Collar
• D78540352SA0: 4mm Straight Abutment 4mm Diameter 2mm Collar
• D78540352OB0: 4mm O-Ball Abutment 4mm Diameter 2mm Collar
• D78540352CB0: 4mm Crown & Bridge Abutment 4mm Diameter 2mm Collar For multiple unit restorations only (not for
• D78540351SA0: 4mm Straight Abutment 4mm Diameter 1mm Collar
• D78532530PA0: 3.25mm PEEK Temporary Straight Abutment 3.25mm Diameter
• D78532530CAA0: 3.25mm Custom Angled 15 Degree Abutment 3.25mm Diameter
• D785325304OB0: 3.25mm O-Ball Abutment 3.25mm Diameter 4mm Collar
• D785325303SA0: 3.25mm Straight Abutment 3.25mm Diameter 3mm Collar
• D785325303OB0: 3.25mm O-Ball Abutment 3.25mm Diameter 3mm Collar
• D785325302SA0: 3.25mm Straight Abutment 4mm Diameter 2mm Collar
• D785325302OB0: 3.25mm O-Ball Abutment 3.25mm Diameter 2mm Collar
• D785325302CB0: 3.25mm Crown & Bridge Abutment 3.25mm Diameter 2mm Collar For multiple unit restorations only (n
• D785325301SA0: 3.25mm Straight Abutment 3.25mm Diameter 1mm Collar
• D785325301CB0: 3.25mm Crown & Bridge Abutment 3.25mm Diameter 1mm Collar For multiple unit restorations only (n