SM INTERNAL/EXTERNAL IMPLANT SYSTEMS AMN 50628N

GUDID 08806195928226

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: 08806195928226
• NIH Device Record Key: 1156d2c2-3b70-420d-9c62-2d39d9e96c5d
• Commercial Distribution Discontinuation: 2022-02-04
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: SM INTERNAL/EXTERNAL IMPLANT SYSTEMS
• Version Model Number: AMN 50628N
• Catalog Number: AMN 50628N
• 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
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	08806195928226 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070569

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-02-24
• Device Publish Date: 2016-01-12

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