Secure Implant System MFP 30216A

GUDID 08800049215081

Secure Implant System(2.5/3.0mm) is a root-form threaded dental implant made of titanium alloy. The implant is produced by machining process, followed by grit blasting and cleaning. It is available in diameters 2.5 and 3.0mm, and lengths from 8mm to 16mm.

DIO Corporation

Screw endosteal dental implant, two-piece

• Primary Device ID: 08800049215081
• NIH Device Record Key: cbbc6595-c3ff-469e-90a6-f12e6d5109d9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Secure Implant System
• Version Model Number: MFP 30216A
• Catalog Number: MFP 30216A
• Company DUNS: 631085206
• Company Name: DIO Corporation
• Device Count: 1
• DM Exempt: true
• 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: true
• Expiration Date: true
• 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: 213-365-2875
• Email: usahq@dioimplantusa.com
• Phone: 213-365-2875
• Email: usahq@dioimplantusa.com
• Phone: 213-365-2875
• Email: usahq@dioimplantusa.com
• Phone: 213-365-2875
• Email: usahq@dioimplantusa.com
• Phone: 213-365-2875
• Email: usahq@dioimplantusa.com
• Phone: 213-365-2875
• Email: usahq@dioimplantusa.com
• Phone: 213-365-2875
• Email: usahq@dioimplantusa.com
• Phone: 213-365-2875
• Email: usahq@dioimplantusa.com
• Phone: 213-365-2875
• Email: usahq@dioimplantusa.com
• Phone: 213-365-2875
• Email: usahq@dioimplantusa.com
• Phone: 213-365-2875
• Email: usahq@dioimplantusa.com
• Phone: 213-365-2875
• Email: usahq@dioimplantusa.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800049215081 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080129

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-03-09
• Device Publish Date: 2022-03-01

On-Brand Devices [Secure Implant System]

• 08806195912591: Secure Implant System(2.5/3.0mm) is a root-form threaded dental implant made of titanium alloy.
• 08806195912584: Secure Implant System(2.5/3.0mm) is a root-form threaded dental implant made of titanium alloy.
• 08806195912577: Secure Implant System(2.5/3.0mm) is a root-form threaded dental implant made of titanium alloy.
• 08806195912560: Secure Implant System(2.5/3.0mm) is a root-form threaded dental implant made of titanium alloy.
• 08806195912553: Secure Implant System(2.5/3.0mm) is a root-form threaded dental implant made of titanium alloy.
• 08806195912546: Secure Implant System(2.5/3.0mm) is a root-form threaded dental implant made of titanium alloy.
• 08806195912539: Secure Implant System(2.5/3.0mm) is a root-form threaded dental implant made of titanium alloy.
• 08806195912522: Secure Implant System(2.5/3.0mm) is a root-form threaded dental implant made of titanium alloy.
• 08806195911860: Secure Implant System(2.5/3.0mm) is a root-form threaded dental implant made of titanium alloy.
• 08806195911846: Secure Implant System(2.5/3.0mm) is a root-form threaded dental implant made of titanium alloy.
• 08806195911822: Secure Implant System(2.5/3.0mm) is a root-form threaded dental implant made of titanium alloy.
• 08806195911808: Secure Implant System(2.5/3.0mm) is a root-form threaded dental implant made of titanium alloy.
• 08806195911785: Secure Implant System(2.5/3.0mm) is a root-form threaded dental implant made of titanium alloy.
• 08806195911761: Secure Implant System(2.5/3.0mm) is a root-form threaded dental implant made of titanium alloy.
• 08806195911747: Secure Implant System(2.5/3.0mm) is a root-form threaded dental implant made of titanium alloy.
• 08806195911723: Secure Implant System(2.5/3.0mm) is a root-form threaded dental implant made of titanium alloy.
• 08800049215364: Secure Implant System(2.5/3.0mm) is a root-form threaded dental implant made of titanium alloy.
• 08800049215302: Secure Implant System(2.5/3.0mm) is a root-form threaded dental implant made of titanium alloy.
• 08800049215241: Secure Implant System(2.5/3.0mm) is a root-form threaded dental implant made of titanium alloy.
• 08800049215180: Secure Implant System(2.5/3.0mm) is a root-form threaded dental implant made of titanium alloy.
• 08800049215081: Secure Implant System(2.5/3.0mm) is a root-form threaded dental implant made of titanium alloy.
• 08800049215029: Secure Implant System(2.5/3.0mm) is a root-form threaded dental implant made of titanium alloy.
• 08800049214961: Secure Implant System(2.5/3.0mm) is a root-form threaded dental implant made of titanium alloy.
• 08800049214909: Secure Implant System(2.5/3.0mm) is a root-form threaded dental implant made of titanium alloy.
• 08800049214329: Secure Implant System(2.5/3.0mm) is a root-form threaded dental implant made of titanium alloy.
• 08800049214268: Secure Implant System(2.5/3.0mm) is a root-form threaded dental implant made of titanium alloy.
• 08800049214206: Secure Implant System(2.5/3.0mm) is a root-form threaded dental implant made of titanium alloy.
• 08800049214145: Secure Implant System(2.5/3.0mm) is a root-form threaded dental implant made of titanium alloy.
• 08800049214046: Secure Implant System(2.5/3.0mm) is a root-form threaded dental implant made of titanium alloy.
• 08800049213988: Secure Implant System(2.5/3.0mm) is a root-form threaded dental implant made of titanium alloy.
• 08800049213926: Secure Implant System(2.5/3.0mm) is a root-form threaded dental implant made of titanium alloy.
• 08800049213865: Secure Implant System(2.5/3.0mm) is a root-form threaded dental implant made of titanium alloy.