Duns Number:124763728
Device Description: Black fabrication male with built-in spacer. Attachments are two-part connectors. One pa Black fabrication male with built-in spacer. Attachments are two-part connectors. One part is intraorally fixed as part of a fixed (i.e. not patient removable) dental restoration, and a replaceable, high density nylon male anchored into a patient removable dental prosthesis (denture base). When the removable prosthesis is seated in the mouth the attachment parts come together and secure it in place. In other applications the attachment connects two sections of a segmented fixed partial denture.
Catalog Number
-
Brand Name
ERA® Micro Partial Males Black (5)
Version/Model Number
811013
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
K020391
Product Code
NHA
Product Code Name
Abutment, Implant, Dental, Endosseous
Public Device Record Key
b9c1c41e-7f8f-43ba-bf35-a516b3071356
Public Version Date
January 09, 2020
Public Version Number
4
DI Record Publish Date
February 21, 2017
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 | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1346 |