Duns Number:439240722
Device Description: DISPOSABLE device in plastic material to be embodied in a removable prosthesis. Cap with s DISPOSABLE device in plastic material to be embodied in a removable prosthesis. Cap with soft retention approx. 900 gr.
Catalog Number
CN001-50
Brand Name
DENTAL EQUIPMENTS
Version/Model Number
PINK CAPS STANDARD size 50u.
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
Yes
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
NHA
Product Code Name
Abutment, Implant, Dental, Endosseous
Public Device Record Key
f4e344ec-7e08-4065-b767-d1f870bd2ae5
Public Version Date
May 07, 2021
Public Version Number
1
DI Record Publish Date
April 29, 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 | 1269 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1987 |