Duns Number:480420090
Device Description: Rack of 6 - 32 mm length - Diam 1.10Peeso Reamers are mechanized dental instruments used f Rack of 6 - 32 mm length - Diam 1.10Peeso Reamers are mechanized dental instruments used for accessing to the root canal and enlarging the opening of the coronal part of the root canal, before and after using files. Peeso Reamers are also used for pin or post hole preparation.
Catalog Number
-
Brand Name
PEESO REAMERS RA, N°3
Version/Model Number
20422
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
-
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
DZA
Product Code Name
Drill, Dental, Intraoral
Public Device Record Key
d063c109-f3b1-4532-92f3-df8a702eb87f
Public Version Date
June 30, 2022
Public Version Number
1
DI Record Publish Date
June 22, 2022
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 | 278 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |