Duns Number:244261462
Device Description: M800X-M/PD, Beyes PD Backend, Quattro Spray, Instant Stop, 25 MTHS WTY (NEW)
Catalog Number
-
Brand Name
AirLight M800X
Version/Model Number
HP6018X
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K112623
Product Code
EFB
Product Code Name
Handpiece, Air-Powered, Dental
Public Device Record Key
8dc18d88-1207-4a09-84f6-fffb3e1439b2
Public Version Date
April 22, 2019
Public Version Number
1
DI Record Publish Date
April 12, 2019
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 | 150 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 17 |
| U | Unclassified | 6 |