IDS Insight Dental Implant System - 5.4x10mm Bone Level Finished System - TITAN IMPLANT SYSTEMS, LLC

Duns Number:080676194

Device Description: 5.4x10mm Bone Level Finished System

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More Product Details

Catalog Number

-

Brand Name

IDS Insight Dental Implant System

Version/Model Number

540010

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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)

-

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

DZE

Product Code Name

Implant, Endosseous, Root-Form

Device Record Status

Public Device Record Key

2d29b0dc-4c78-47e8-814d-197a014d08a7

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 09, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TITAN IMPLANT SYSTEMS, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 35
2 A medical device with a moderate to high risk that requires special controls. 1