Duns Number:439240722
Device Description: DISPOSABLE device used to provide retention of a removable prosthesis anchored on metal he DISPOSABLE device used to provide retention of a removable prosthesis anchored on metal hemi-spheres fixed in the mouth.
Catalog Number
192ECE-IQ
Brand Name
OT EQUATOR - OT BRIDGE
Version/Model Number
EQUATOR CAPS ASSORTMENT KIT, (1 Pack)
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
EGG
Product Code Name
Attachment, Precision, All
Public Device Record Key
77ab3f95-fa9f-4703-8e20-31281df4806b
Public Version Date
July 28, 2021
Public Version Number
1
DI Record Publish Date
July 20, 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 |