4OZ TIDEWATER TEAL TROPICAL TO - 4OZ TIDEWATER TEAL TROPICAL TO - Great Lakes Dental Technologies, Ltd.

Duns Number:041854332

Device Description: 4OZ TIDEWATER TEAL TROPICAL TO

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More Product Details

Catalog Number

045-080

Brand Name

4OZ TIDEWATER TEAL TROPICAL TO

Version/Model Number

045-080

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

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 Details

Product Code

EBI

Product Code Name

Resin, Denture, Relining, Repairing, Rebasing

Device Record Status

Public Device Record Key

8bda3dd7-a7b4-4adf-93de-6f86b7e1b610

Public Version Date

February 02, 2021

Public Version Number

3

DI Record Publish Date

August 18, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GREAT LAKES DENTAL TECHNOLOGIES, LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 45
2 A medical device with a moderate to high risk that requires special controls. 183