Duns Number:689605054
Device Description: The DENTIOIII-S is intended for dental radiographic examination of the teeth and temporoma The DENTIOIII-S is intended for dental radiographic examination of the teeth and temporomandibular joints, specifically for panoramic and cephalometric examinations. It is to be used only by dental practitioners and/or radiologists.
Catalog Number
-
Brand Name
DENTIOIII series
Version/Model Number
DENTIOIII-S
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K181297
Product Code
MUH
Product Code Name
System, X-Ray, Extraoral Source, Digital
Public Device Record Key
f9e90711-4391-468c-8236-42d4651b42c7
Public Version Date
January 06, 2022
Public Version Number
3
DI Record Publish Date
March 04, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 19 |