Duns Number:429341410
Device Description: The device is a dental unit consisting of components and/or devices that are functionally The device is a dental unit consisting of components and/or devices that are functionally connected, such as the patient dental chair, dental handpieces, multifunction pedal.In this version, the hydric unit and the dentist board are not present. The device consists of the single dental chair and, optionally, of the assistant's board with instruments connected to it.The patient dental chair can mount single-phase lifting motors (catalog number: 72H1XXXX) or three-phase lifting motors (catalog number: 72H2XXXX).The last four characters "XXXX" of the catalog number can be different alphanumeric characters.
Catalog Number
72H1XXXX, 72H2XXXX
Brand Name
Anthos
Version/Model Number
R7 P
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
-
Product Code
EIA
Product Code Name
Unit, Operative Dental
Public Device Record Key
dbac464c-197d-49dc-b3cd-8469c4575939
Public Version Date
November 16, 2021
Public Version Number
1
DI Record Publish Date
November 08, 2021
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 |