Duns Number:429341410
Device Description: The NewTom DCiS is a wireless sensor intended to capture intraoral digital images when exp The NewTom DCiS is a wireless sensor intended to capture intraoral digital images when exposed to X-Rays.
Catalog Number
701FW001
Brand Name
NewTom
Version/Model Number
NewTom DCiS
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
K211688
Product Code
MUH
Product Code Name
System,X-Ray,Extraoral Source,Digital
Public Device Record Key
600778d2-4d48-4f4c-a902-9f76469d9d5d
Public Version Date
September 26, 2022
Public Version Number
1
DI Record Publish Date
September 18, 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 | 33 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 63 |