EBD
- Product code
- EBD
- Device name
- Coating, Filling Material, Resin
- Device class
- Class 2
- 21 CFR
- 21 CFR 872.3310
- Medical specialty
- Dental
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 3
- Summaries archived here
- 3 (direct download)
- 510(k) clearances (all years, FDA)
- 52 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (3)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K254091 | 2026-04-06 | YAMAHACHI DENTAL MFG., Co. | GLOSSY COAT (15ML) | |
| K250804 | 2025-06-04 | Id Korea Co., Ltd. | ID LIGHT CURE SYSTEM | |
| K240735 | 2024-12-12 | Bredent GmbH & Co. KG | visio.lign color, visio.lign shield |
Official FDA classification page: EBD
Classification and pathway per current FDA publications. Data from openFDA (CC0).