Duns Number:459955188
Device Description: ORTHOPANTOMOGRAPH OP 3D cranio-maxillofacial xray device for panoramic, cephalometric and ORTHOPANTOMOGRAPH OP 3D cranio-maxillofacial xray device for panoramic, cephalometric and cbct images
Catalog Number
900992
Brand Name
ORTHOPANTOMOGRAPH OP 3D
Version/Model Number
PCX-1
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
K180947
Product Code
OAS
Product Code Name
X-Ray, Tomography, Computed, Dental
Public Device Record Key
1e27de8f-db4d-416c-9394-237d23ac604a
Public Version Date
February 26, 2019
Public Version Number
2
DI Record Publish Date
July 11, 2018
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 | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 93 |