Chromaclone - Chromaclone Ortho 5-day Kit Extra Fast Set - ULTRADENT PRODUCTS, INC.

Duns Number:013369913

Device Description: Chromaclone Ortho 5-day Kit Extra Fast Set

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More Product Details

Catalog Number

5502

Brand Name

Chromaclone

Version/Model Number

5502

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

-

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

K043118

Product Code Details

Product Code

ELW

Product Code Name

MATERIAL, IMPRESSION

Device Record Status

Public Device Record Key

6e4c8313-39b9-4eca-8952-a4bd79e227a3

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 22, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ULTRADENT PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 450
2 A medical device with a moderate to high risk that requires special controls. 631
U Unclassified 18