NuSmile NeoPUTTY Introductory Kit 0.5gm - A paste product designed for endodontic surgery - NUSMILE, LTD.

Duns Number:185497372

Device Description: A paste product designed for endodontic surgery or perforations, and vital pulp therapy.

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More Product Details

Catalog Number

-

Brand Name

NuSmile NeoPUTTY Introductory Kit 0.5gm

Version/Model Number

NNPIK

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)

-

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

-

Product Code Name

-

Device Record Status

Public Device Record Key

21cbc09f-7b55-4996-b1d4-bf462e502585

Public Version Date

December 08, 2021

Public Version Number

4

DI Record Publish Date

December 10, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NUSMILE, LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1091
2 A medical device with a moderate to high risk that requires special controls. 16
U Unclassified 1