SECURE IMPLANT SYSTEM(2.5/3.0MM) - Secure Implant System(2.5/3.0MM) is a root-form - DIO Corporation

Duns Number:631085206

Device Description: Secure Implant System(2.5/3.0MM) is a root-form threaded dental implant made of titanium a 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.

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More Product Details

Catalog Number

MHC 5008

Brand Name

SECURE IMPLANT SYSTEM(2.5/3.0MM)

Version/Model Number

MHC 5008

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 28, 2022

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

NHA

Product Code Name

Abutment, Implant, Dental, Endosseous

Device Record Status

Public Device Record Key

cbca5243-5f4c-4588-bcb1-c79e8c663177

Public Version Date

February 28, 2022

Public Version Number

4

DI Record Publish Date

January 25, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DIO CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 101
2 A medical device with a moderate to high risk that requires special controls. 3540