Catalog Number

-

Brand Name

TRIOS®

Version/Model Number

T12-Ctip

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

NOF

Product Code Name

System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations

Public Device Record Key

7d6060b7-05da-4530-bb00-d62c5161f0b4

Public Version Date

February 21, 2022

Public Version Number

2

DI Record Publish Date

February 26, 2019

Package DI Number

05902768365740

Quantity per Package

5

Contains DI Package

05902768365986

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box