Duns Number:017009932
Device Description: Size #1 Pedo Dental X-Ray Sensor for radiographic examination and diagnosis of diseases of Size #1 Pedo Dental X-Ray Sensor for radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structure.
Catalog Number
-
Brand Name
Apex
Version/Model Number
S11684-12-71
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
K163282
Product Code
MUH
Product Code Name
System,X-Ray,Extraoral Source,Digital
Public Device Record Key
19a1104b-e91d-460e-9339-ae3214b05070
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
May 18, 2017
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |