ORA Implant Abutment 2.0mm Cuff (A)
STERNGOLD DENTAL LLC · Model 904336 · UDI-DI 00841549110993
Description
Implant Interface design varies, dependent upon implant type. The ORA System is indicated for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function. The abutment screws directly into endosseous implants or they screw into SFI Abutments which are screwed into endosseous implants. The ORA Implant Abutment System is a precision machined ball shaped abutment that connects a compatible dental implant system with a removable partial or complete overdenture. The implant abutment is screwed into the dental implant. Connection to and retention of a denture is provided by a rubber o-ring, which may or may not be held within a metal housing. There are two color o-rings, a red processing o-ring and a white final o-ring. Connection and retention may also be provided by a plastic keeper that is processed into the denture.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-13 | Straumann USA LLC | There may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label. If the the incorrect implant is installed, the i |
| 2026-03-27 | Straumann USA LLC | Includes an incorrect screw seat interface. |
| 2026-03-27 | Straumann USA LLC | Includes an incorrect screw seat interface. |
| 2026-03-17 | Straumann USA LLC | A material mix-up had occurred during the manufacturing of Straumann Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701924 / Lot 7130439) was incorre |
| 2026-03-17 | Straumann USA LLC | A material mix-up had occurred during the manufacturing of Straumann Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701924 / Lot 7130439) was incorre |
| 2025-09-30 | Prismatik Dentalcraft, Inc. | Incorrect titanium screw, packaged with dental implant. |
| 2025-06-25 | Preat Corp | Engaging titanium base was manufactured 180 degrees around the post from where it should be located in relation to the connection geometry; if the flat is on the wrong side of the |
| 2025-06-24 | Preat Corp | Due to manufacturing error, digital analog rotational feature is 180 degrees off. |
| 2025-04-17 | Straumann USA LLC | Incorrect blister labelling. |
| 2025-04-02 | Preat Corp | Due to manufacturing issues, abutment products were manufactured with screw seat located too high, which may cause the mating screw to have a shorter engagement length into the ass |
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