510(k) K213812 ยท LOD Bone Cement
PALACOS MV pro
| Applicant | Heraeus Medical GmbH, Wehrheim, DE |
| Decision | Substantially Equivalent, Feb 2, 2022 |
| Received | Dec 7, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213812
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 25, 2026 | Heraeus Medical GmbH (Dental Division) PALACOS MV pro 40; PALACOS MV pro 80. Model/Catalog Number: 5150633; 5150635.
Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitabl Open, Classified |
LOD | None listed |
| Jan 14, 2026 | Heraeus Medical GmbH (Dental Division) Brand Name: PALACOS
Product Name: PALACOS MV pro 40; PALACOS MV pro 80
Model/Catalog Number: 5150633; 5150635
Software Version: N/A
Product Description: Radiopaque, poly(methyl methacrylate)-based (PM Open, Classified |
LOD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.