Duns Number:185497372
Device Description: A paste product designed for endodontic surgery or perforations, and vital pulp therapy.
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
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"
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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
-
Product Code Name
-
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
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
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 |