Company
Heraeus Medical GmbH (Dental Division)
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
10recalls (10 in 12 months)
8recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| 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 | K213812 |
| 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 | K210607 |
| 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 | K210607 |
| 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 | K210607 |
| Apr 29, 2026 | Heraeus Medical GmbH (Dental Division) Heraeus, PALAMIX duo. Material Number: 66057897. Open, Classified |
JDZ | None listed |
| Apr 29, 2026 | Heraeus Medical GmbH (Dental Division) Heraeus, PALAMIX uno. Material Number: 66057893. Open, Classified |
JDZ | 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 | K213812 |
| 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 | K210607 |
| 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 | K210607 |
| 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 | K210607 |