Paltop - POP Kit Shade A2 - PALTOP ADVANCED DENTAL SOLUTIONS LTD

Duns Number:533836024

Device Description: POP Kit Shade A2

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

45-70072

Brand Name

Paltop

Version/Model Number

45-70072

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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

ELM

Product Code Name

Denture, plastic, teeth

Device Record Status

Public Device Record Key

d81d0eec-a9d8-4731-979d-fd6bef1f97e5

Public Version Date

May 11, 2022

Public Version Number

1

DI Record Publish Date

May 03, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PALTOP ADVANCED DENTAL SOLUTIONS LTD" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 258
2 A medical device with a moderate to high risk that requires special controls. 633