Duns Number:480082080
Device Description: Bien-Air Dental contra-angle and straight handpieces are designed to transmit and apply th Bien-Air Dental contra-angle and straight handpieces are designed to transmit and apply the mechanical energy produced by an electric or air micromotor.Product intended for use in oral and maxillofacial surgery.
Catalog Number
1601190-001
Brand Name
PM 1:1 TWIST DRILL
Version/Model Number
1601190-001
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
GFA
Product Code Name
Blade, Saw, General & Plastic Surgery, Surgical
Public Device Record Key
88f55f38-337a-44e9-9c24-afa1d58e69cf
Public Version Date
July 20, 2022
Public Version Number
1
DI Record Publish Date
July 12, 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 | 213 |