Osteotomy Former 0330TN

GUDID D7850330T0

3.3mm Osteotomy Former 3.3mm Diameter For placement of the 3.6mm Engage Implant (Lower)

OCO BIOMEDICAL INC

Fixture/appliance dental drill bit, reusable

• Primary Device ID: D7850330T0
• NIH Device Record Key: 10dc7f98-b39e-4362-9086-741e457aac1b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Osteotomy Former
• Version Model Number: 3.3mm Osteotomy Former
• Catalog Number: 0330TN
• Company DUNS: 094146123
• Company Name: OCO BIOMEDICAL INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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	D7850330T0 [Primary]

FDA Product Code

• DZA: Drill, Dental, Intraoral

Sterilization

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

[D7850330T0]

Moist Heat or Steam Sterilization

[D7850330T0]

Moist Heat or Steam Sterilization

[D7850330T0]

Moist Heat or Steam Sterilization

[D7850330T0]

Moist Heat or Steam Sterilization

[D7850330T0]

Moist Heat or Steam Sterilization

[D7850330T0]

Moist Heat or Steam Sterilization

[D7850330T0]

Moist Heat or Steam Sterilization

[D7850330T0]

Moist Heat or Steam Sterilization

[D7850330T0]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-11
• Device Publish Date: 2024-12-03

On-Brand Devices [Osteotomy Former]

• D7850560T0: 5.6mm Osteotomy Former 5.6mm Diameter
• D7850470T0: 4.7mm Osteotomy Former 4.7mm Diameter For placement of the 5mm ISI/TSI/ERI Mandibular Implant
• D7850450T0: 4.5mm Osteotomy Former 4.5mm Diameter For placement of the 5mm ISI/TSI/ERI Maxillary Implant
• D7850370T0: 3.7mm Osteotomy Former 3.7mm Diameter For placement of the 4mm ISI/TSI/ERI Mandibular Implant
• D7850350T0: 3.5mm Osteotomy Former 3.5mm Diameter For placement of the 4mm ISI/TSI/ERI Maxillary Implant
• D7850300T0: 3mm Osteotomy Former 3mm Diameter For placement of the 3.25mm ISI/TSI/ERI Mandibular Implant
• D7850280T0: 2.8mm Osteotomy Former 2.8mm Diameter For placement of the 3.25mm ISI/TSI/ERI Maxillary Implant
• D7850240T0: 2.4mm Osteotomy Former 2.4mm Diameter For placement of the 3mm Implant
• D7850330T0: 3.3mm Osteotomy Former 3.3mm Diameter For placement of the 3.6mm Engage Implant (Lower)