X-Smart IQ - X-Smart IQ Basic - TULSA DENTAL PRODUCTS LLC

Duns Number:942778564

Device Description: X-Smart IQ Basic

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More Product Details

Catalog Number

XSIQEM1BSK

Brand Name

X-Smart IQ

Version/Model Number

XSIQEM1BSK

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

EBW

Product Code Name

Controller, foot, handpiece and cord

Device Record Status

Public Device Record Key

1b89cdfa-714d-4ba9-ac4f-6691d1f91be8

Public Version Date

August 09, 2022

Public Version Number

1

DI Record Publish Date

August 01, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TULSA DENTAL PRODUCTS LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1973
2 A medical device with a moderate to high risk that requires special controls. 35
U Unclassified 16