Bone Level Implant Abutment 4035-3SA

GUDID D78540353SA0

4mm Straight Abutment 4mm Diameter 3mm Collar

OCO BIOMEDICAL INC

Dental implant system

• Primary Device ID: D78540353SA0
• NIH Device Record Key: fb880a4b-a714-43df-b21c-d07a1077d74a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bone Level Implant Abutment
• Version Model Number: 4mm Straight Abutment
• Catalog Number: 4035-3SA
• 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	D78540353SA0 [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

[D78540353SA0]

Moist Heat or Steam Sterilization

[D78540353SA0]

Moist Heat or Steam Sterilization

[D78540353SA0]

Moist Heat or Steam Sterilization

[D78540353SA0]

Moist Heat or Steam Sterilization

[D78540353SA0]

Moist Heat or Steam Sterilization

[D78540353SA0]

Moist Heat or Steam Sterilization

[D78540353SA0]

Moist Heat or Steam Sterilization

[D78540353SA0]

Moist Heat or Steam Sterilization

[D78540353SA0]

Moist Heat or Steam Sterilization

[D78540353SA0]

Moist Heat or Steam Sterilization

[D78540353SA0]

Moist Heat or Steam Sterilization

[D78540353SA0]

Moist Heat or Steam Sterilization

[D78540353SA0]

Moist Heat or Steam Sterilization

[D78540353SA0]

Moist Heat or Steam Sterilization

[D78540353SA0]

Moist Heat or Steam Sterilization

[D78540353SA0]

Moist Heat or Steam Sterilization

[D78540353SA0]

Moist Heat or Steam Sterilization

[D78540353SA0]

Moist Heat or Steam Sterilization

[D78540353SA0]

Moist Heat or Steam Sterilization

[D78540353SA0]

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