Duns Number:001804074
Device Description: Anatomical wood matrix wedges, assortment of sizes - 25 ea - small, medium, large, and ext Anatomical wood matrix wedges, assortment of sizes - 25 ea - small, medium, large, and extra large
Catalog Number
061315-000
Brand Name
Waterpik Wizard Wedges
Version/Model Number
061315-000
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DZN
Product Code Name
Instruments, Dental Hand
Public Device Record Key
73e56663-b505-4b1d-9caa-580485eab191
Public Version Date
September 08, 2020
Public Version Number
1
DI Record Publish Date
August 31, 2020
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 | 293 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 56 |