SM INTERNAL/EXTERNAL IMPLANT SYSTEMS SHN 2011S

GUDID 08800049287118

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 Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece

Primary Device ID	08800049287118
NIH Device Record Key	397eac8b-39eb-45dc-95a1-029f990064d6
Commercial Distribution Status	In Commercial Distribution
Brand Name	SM INTERNAL/EXTERNAL IMPLANT SYSTEMS
Version Model Number	SHN 2011S
Catalog Number	SHN 2011S
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

Device Dimensions

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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	08800049287118 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K070569

FDA Product Code

DZE	Implant, Endosseous, Root-Form