SM INTERNAL/EXTERNAL IMPLANT SYSTEMS API 48514

GUDID 08800049407240

SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. The implant is produced by machining process, followed by grit blasting and cleaning. It is available in diameters 3.8, 4.5 and 5.3mm, and lengths from 8mm to 14mm. It is placed via one or two stage surgery and the functional loading can be from immediated to delay.

DIO Corporation

Screw endosteal dental implant, two-piece

• Primary Device ID: 08800049407240
• NIH Device Record Key: 539888cd-c52d-4fdc-883f-8c4f29ad83d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SM INTERNAL/EXTERNAL IMPLANT SYSTEMS
• Version Model Number: API 48514
• Catalog Number: API 48514
• 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: 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: 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
• 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
• 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
• 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	08800049407240 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070569

FDA Product Code

• DZE: Implant, Endosseous, Root-Form
• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08800049407240]

Moist Heat or Steam Sterilization

[08800049407240]

Moist Heat or Steam Sterilization

[08800049407240]

Moist Heat or Steam Sterilization

[08800049407240]

Moist Heat or Steam Sterilization

[08800049407240]

Moist Heat or Steam Sterilization

[08800049407240]

Moist Heat or Steam Sterilization

[08800049407240]

Moist Heat or Steam Sterilization

[08800049407240]

Moist Heat or Steam Sterilization

[08800049407240]

Moist Heat or Steam Sterilization

[08800049407240]

Moist Heat or Steam Sterilization

[08800049407240]

Moist Heat or Steam Sterilization

[08800049407240]

Moist Heat or Steam Sterilization

[08800049407240]

Moist Heat or Steam Sterilization

[08800049407240]

Moist Heat or Steam Sterilization

[08800049407240]

Moist Heat or Steam Sterilization

[08800049407240]

Moist Heat or Steam Sterilization

[08800049407240]

Moist Heat or Steam Sterilization

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 [SM INTERNAL/EXTERNAL IMPLANT SYSTEMS]

• 08806195929612: SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T
• 08806195929605: SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T
• 08806195929599: SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T
• 08806195929421: SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T
• 08806195929780: SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T
• 08806195929773: SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T
• 08806195929766: SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T
• 08806195929759: SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T
• 08806195929742: SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T
• 08806195929735: SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T
• 08806195929728: SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T
• 08806195929711: SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T
• 08806195929698: SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T
• 08806195929667: SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T
• 08806195929643: SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T
• 08806195929636: SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T
• 08806195929629: SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T
• 08806195929582: SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T
• 08806195929575: SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T
• 08806195929568: SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T
• 08806195929551: SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T
• 08806195929544: SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T
• 08806195929537: SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T
• 08806195929520: SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T
• 08806195929513: SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T
• 08806195929506: SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T
• 08806195929490: SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T
• 08806195929483: SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T
• 08806195929476: SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T
• 08806195929469: SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T
• 08806195929452: SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T
• 08806195929445: SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T
• 08806195929438: SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T
• 08806195929414: SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T
• 08806195929407: SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T
• 08806195929391: SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T
• 08806195929384: SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T
• 08806195929377: SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T
• 08806195929360: SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T
• 08806195929353: SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T
• 08806195929346: SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T
• 08806195929339: SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T
• 08806195929308: SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T
• 08806195929292: SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T
• 08806195929285: SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T
• 08806195929186: SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T
• 08806195929179: SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T
• 08806195929162: SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T
• 08806195929155: SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T
• 08806195929148: SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T