Catalog Number

G-91820K

Brand Name

DT Illusion XRO Intro Kit

Version/Model Number

G-91820K

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 10, 2020

Issuing Agency

In HIBCC

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

DZA

Product Code Name

DRILL, DENTAL, INTRAORAL

Public Device Record Key

500090d5-ba26-4266-9f97-cb5c48a7fc72

Public Version Date

September 25, 2020

Public Version Number

2

DI Record Publish Date

November 06, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-