Device type
Material, Tooth Shade, Resin
Product code EBF · Class II · 21 CFR 872.3690 · Dental
Recent 510(k)s
Sep 21, 2026
K262982
Core·it Dual
Spident Co., Ltd.
- EBF
- Class II
Sep 10, 2026
K262202
Cerasmart Forte
GC America, Inc.
- EBF
- Class II
Aug 31, 2026
K261695
Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)
Guilin Kevin Peter Technology Co., Ltd.
- EBF
- Class II
Recent recalls
Sep 2, 2026
Z-3015-2026
Structur 2 SC Temporary Resin Cartridge Refill 75Gm, Product Codes: 1) 114-3933, Mfr Product Code 1479; Lots 2536179, 2606429 2) 114-3934, Mfr Product Code 148…
Henry Schein Inc.
- EBF
- Class II
- Ongoing
Sep 2, 2026
Z-3016-2026
Grandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm, Product Codes: 1) 949-3594, Mfr Product Code 1840; Lots 2529604, 2538147, 2608145 2) 949-…
Henry Schein Inc.
- EBF
- Class II
- Ongoing