Duns Number:276075371
Device Description: Endodontic instrument for professionnal dental use only
Catalog Number
20122014
Brand Name
SPIRAL FILLERS
Version/Model Number
n45 L25
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
EIY
Product Code Name
Instrument, Filling, Plastic, Dental
Public Device Record Key
d4874c45-1f9e-4986-ad31-03e3eb157c1d
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
August 28, 2020
Package DI Number
J015201220149
Quantity per Package
10
Contains DI Package
J015201220141
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 64 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |