510(k) K210607 ยท LOD Bone Cement
PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro
| Applicant | Heraeus Medical GmbH, Wehrheim, DE |
| Decision | Substantially Equivalent, Jul 9, 2021 |
| Received | Mar 1, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210607
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 25, 2026 | Heraeus Medical GmbH (Dental Division) PALACOS R pro 40; PALACOS R pro 80. Model/Catalog Numbers: 5081286; 5081287.
Radiopaque, poly (methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable Open, Classified |
LOD | None listed |
| Sep 25, 2026 | Heraeus Medical GmbH (Dental Division) PALACOS R+G pro 40; PALACOS R+G pro 80. Model/Catalog Number: 5081288; 5081289.
Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suita Open, Classified |
MBB | None listed |
| Sep 25, 2026 | Heraeus Medical GmbH (Dental Division) PALACOS MV+G pro 40; PALACOS MV+G pro 80. Model/Catalog Number: 5081290; 5081291.
Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suit Open, Classified |
MBB | None listed |
| Jan 14, 2026 | Heraeus Medical GmbH (Dental Division) Brand Name: PALACOS
Product Name: PALACOS R pro 40; PALACOS R pro 80
Model/Catalog Number: 5081286; 5081287
Software Version: N/A
Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA Open, Classified |
LOD | None listed |
| Jan 14, 2026 | Heraeus Medical GmbH (Dental Division) Brand Name: PALACOS
Product Name: PALACOS R+G pro 40; PALACOS R+G pro 80
Model/Catalog Number: 5081288; 5081289
Software Version: N/A
Product Description: Radiopaque, poly(methyl methacrylate)-based ( Open, Classified |
LOD | None listed |
| Jan 14, 2026 | Heraeus Medical GmbH (Dental Division) Brand Name: PALACOS
Product Name: PALACOS MV+G pro 40; PALACOS MV+G pro 80
Model/Catalog Number: 5081290; 5081291
Software Version: N/A
Product Description: Radiopaque, poly(methyl methacrylate)-based Open, Classified |
LOD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.