Duns Number:124763728
Device Description: This part contains: Small diameter post females, 2-0° plus one each 5°, 11°, and 17°, Larg This part contains: Small diameter post females, 2-0° plus one each 5°, 11°, and 17°, Large diameter post females, 2-0° plus one each 5°, 11°, and 17°, Males, 10 sets of 5 - 2 ea of white, black and 1 orange, 2 metal jackets, 2 sets of 4, Processing jigs, 4, Alignment handles, 4, Pilot drills, 2 blockout spacers, 1 small diameter and 1 large diameter, Countersink burs, 1 small diameter and 1 large diameter, Gutta percha drill, core cutter bur and seating tool. These attachments are placed in the retained tooth root, which has been prepared to receive the fixed attachment component. The other component of the attachment becomes part of a patient removable overdenture, which is a denture partially supported by one or more retained roots. ERA Direct Placement Overdenture is available in standard and micro sizes. An optional metal jacket is also available to hold the attachment male in the denture base and is sold pre-loaded with a black fabrication male. Intended to support and/or retain removable dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function.
Catalog Number
-
Brand Name
ERA® Direct Overdenture Mixed Kit SS
Version/Model Number
811398
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
a1b3308b-18ff-4621-9667-f068d27e7254
Public Version Date
July 15, 2020
Public Version Number
1
DI Record Publish Date
July 07, 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 | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1346 |