Home › Panthera Dentaire Inc › Panthera Dental Milled Bar
Panthera Dental Milled Bar
Panthera Dentaire Inc · Model 1 · UDI-DI 07540204000046
NHA
Prescription
3
510(k) clearances
8,580
Adverse events (1 deaths)
225
Recalls
378
Facilities
Description
The Panthera Dental Milled Bar is indicated for use as an accessory to an endosseous dental implant to support a prosthetic device in a partially or edentulous patient for purpose of restoring chewing function. It is intended for use to support multiple tooth prostheses in the mandible or maxilla. The prostheses can be screw retained.
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 |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.