Duns Number:005036025
Device Description: The Procenter Concept LR Mounted Cuspidor is intended to provide water for oral rinsing, a The Procenter Concept LR Mounted Cuspidor is intended to provide water for oral rinsing, and a drain to dispose of waste water and oral debris during dental examinations.
Catalog Number
153603LR
Brand Name
Midmark
Version/Model Number
153603LR
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
K003090
Product Code
EIA
Product Code Name
Unit, operative dental
Public Device Record Key
027addf2-9270-47fb-a08d-4d60aee5dc89
Public Version Date
June 01, 2020
Public Version Number
1
DI Record Publish Date
May 22, 2020
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 | 838 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 544 |