Duns Number:480082080
Device Description: CA and HP are intended to transmit and apply the mechanical energy produced by a dental ai CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Catalog Number
1600940-001
Brand Name
PM CA 1:5L EVO15 Micro-Series
Version/Model Number
1600940-001
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
EFB
Product Code Name
Handpiece, air-powered, dental
Public Device Record Key
c7c719fe-66ba-48d8-b7cf-5206c22b09ec
Public Version Date
June 30, 2021
Public Version Number
2
DI Record Publish Date
June 17, 2021
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 | 213 |