4.2mm Tap 701-0014

GUDID 00810118210013

4.2mm Tap

Osteocentric Technologies, Inc.

Dental implant system

• Primary Device ID: 00810118210013
• NIH Device Record Key: 20640f0a-52d9-4a06-9c34-6815b2bcd3c9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 4.2mm Tap
• Version Model Number: 701-0014
• Catalog Number: 701-0014
• Company DUNS: 089645059
• Company Name: Osteocentric Technologies, 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: 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

Customer Support Contacts

• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com

Device Dimensions

• Outer Diameter: 4.2 Millimeter
• Outer Diameter: 4.2 Millimeter
• Outer Diameter: 4.2 Millimeter
• Outer Diameter: 4.2 Millimeter
• Outer Diameter: 4.2 Millimeter
• Outer Diameter: 4.2 Millimeter
• Outer Diameter: 4.2 Millimeter
• Outer Diameter: 4.2 Millimeter
• Outer Diameter: 4.2 Millimeter
• Outer Diameter: 4.2 Millimeter
• Outer Diameter: 4.2 Millimeter
• Outer Diameter: 4.2 Millimeter
• Outer Diameter: 4.2 Millimeter
• Outer Diameter: 4.2 Millimeter
• Outer Diameter: 4.2 Millimeter
• Outer Diameter: 4.2 Millimeter
• Outer Diameter: 4.2 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810118210013 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230242

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

[00810118210013]

Moist Heat or Steam Sterilization

[00810118210013]

Moist Heat or Steam Sterilization

[00810118210013]

Moist Heat or Steam Sterilization

[00810118210013]

Moist Heat or Steam Sterilization

[00810118210013]

Moist Heat or Steam Sterilization

[00810118210013]

Moist Heat or Steam Sterilization

[00810118210013]

Moist Heat or Steam Sterilization

[00810118210013]

Moist Heat or Steam Sterilization

[00810118210013]

Moist Heat or Steam Sterilization

[00810118210013]

Moist Heat or Steam Sterilization

[00810118210013]

Moist Heat or Steam Sterilization

[00810118210013]

Moist Heat or Steam Sterilization

[00810118210013]

Moist Heat or Steam Sterilization

[00810118210013]

Moist Heat or Steam Sterilization

[00810118210013]

Moist Heat or Steam Sterilization

[00810118210013]

Moist Heat or Steam Sterilization

[00810118210013]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-07
• Device Publish Date: 2023-10-30

Devices Manufactured by Osteocentric Technologies, Inc.

• 00816950029523 - QC T-Handle Quarter In Square: 2024-07-16 QC T-Handle Quarter In Square
• 00816950029547 - 5.2mm Fastener Tap: 2024-07-16 5.2mm Fastener Tap
• 00816950029554 - 6.0mm Fastener Tap: 2024-07-16 6.0mm Fastener Tap
• 00816950029561 - 3.5mm Hex Driver AO QC: 2024-07-16 3.5mm Hex Driver AO QC
• 00816950029578 - 3.5mm Hex Driver: 2024-07-16 3.5mm Hex Driver
• 00816950020773 - 34mm, 2.7mm Cortical Screw, Self-Tapping: 2024-02-19 34mm, 2.7mm Cortical Screw, Self-Tapping
• 00816950020797 - 36mm, 2.7mm Cortical Screw, Self-Tapping: 2024-02-19 36mm, 2.7mm Cortical Screw, Self-Tapping
• 00816950020810 - 38mm, 2.7mm Cortical Screw, Self-Tapping: 2024-02-19 38mm, 2.7mm Cortical Screw, Self-Tapping