Cuxhaven, DE · 17 510(k) clearances · 2 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | Class II | Dental | 5 | 2026-04-27 |
| EMA | Cement, Dental | Class II | Dental | 3 | 2026-03-20 |
| EBI | — | — | — | 2 | 2022-09-21 |
| LBH | Varnish, Cavity | Class II | Dental | 1 | 2026-05-01 |
| KIF | — | — | — | 1 | 2025-07-03 |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | Class II | Dental | 1 | 2023-12-01 |
| POW | Crown And Bridge, Long-Term Temporary, Resin | Class II | Dental | 1 | 2023-07-31 |
| MVL | Cord, Retraction | Unclassified | Unknown | 1 | 2021-12-09 |
| MQC | — | — | — | 1 | 2020-11-06 |
| EBG | Crown And Bridge, Temporary, Resin | Class II | Dental | 1 | 2020-09-09 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2024-01-25 | Class II | Ongoing | Z-1143-2024 | Ionolux, Catalog (REF) Numbers: a) 2115, b)2117, c) 2118, d) 2119, e) 2120, f) 2122; dental cement | — | Due to an error in the manufacturing process, it is possible that an incorrect plunger has been fitted to some capsules. This plunger does not contain the corre… |
| 2024-01-25 | Class II | Ongoing | Z-1142-2024 | IonoStar Plus, Catalog (REF) Numbers: a) 2540, b)2543, c) 2544, d) 2545, e) 2546, f) 2547, g) 2549; dental cement | — | Due to an error in the manufacturing process, it is possible that an incorrect plunger has been fitted to some capsules. This plunger does not contain the corre… |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-05-01 | K252073 | VOCO Profluorid Varnish + BioMin | LBH | Class II | Dental |
| 2026-04-27 | K261357 | Grandio disc multicolor | EBF | Class II | Dental |
| 2026-03-20 | K252606 | Bifix Veneer LC, Bifix Veneer Try-In | EMA | Class II | Dental |
| 2025-07-03 | K251390 | MTA vpt | KIF | — | — |
| 2025-05-21 | K251239 | GrandioSO Unlimited | EBF | Class II | Dental |
| 2023-12-01 | K231817 | AlignerFlow LC | DYH | Class II | Dental |
| 2023-07-31 | K231591 | V-Print c&b temp | POW | Class II | Dental |
| 2023-07-13 | K230877 | Admira Fusion 5 | EBF | Class II | Dental |
| 2022-09-21 | K220236 | V-Print dentbase | EBI | — | — |
| 2022-08-23 | K220640 | Bifix Hybrid Abutment Cement | EMA | Class II | Dental |
| 2022-07-05 | K220743 | CediTEC | EBI | — | — |
| 2021-12-09 | K213149 | VOCO Retraction Paste | MVL | Unclassified | Unknown |
| 2020-11-06 | K201091 | V-Print splint | MQC | — | — |
| 2020-09-09 | K201090 | Structur CAD | EBG | Class II | Dental |
| 2020-08-26 | K201856 | Provicol QM Aesthetic | EMA | Class II | Dental |
| 2020-07-08 | K201307 | VisCalor | EBF | Class II | Dental |
| 2020-03-27 | K200294 | GrandioSO Light Flow | EBF | Class II | Dental |