Pearson Quality Super Concentrated General Purpose Ultrasonic Cleaning Solution - Pearson Dental Tartar and Stain Remover, 16 oz. - DENTSPLY INTERNATIONAL INC.

Duns Number:083235549

Device Description: Pearson Dental Tartar and Stain Remover, 16 oz. Bottle

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More Product Details

Catalog Number

2221368FG

Brand Name

Pearson Quality Super Concentrated General Purpose Ultrasonic Cleaning Solution

Version/Model Number

2221368FG

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)

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

EFT

Product Code Name

CLEANSER, DENTURE, OVER THE COUNTER

Device Record Status

Public Device Record Key

af1dc651-59f7-42ca-8fee-d8e87110fb13

Public Version Date

July 07, 2020

Public Version Number

3

DI Record Publish Date

September 21, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DENTSPLY INTERNATIONAL INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 123
2 A medical device with a moderate to high risk that requires special controls. 397
U Unclassified 2