One-Fil LC
Mediclus Co., Ltd. · Dental
Open FDA's page for this record- Third party flag
- N
- City
- Cheongju-Si
- Advisory committee description
- Dental
- Address 1
- # 1210, 134, Gongdan-Ro, Heungdeok-Gu
- Statement or summary
- Summary
- Product code
- EJK
- Zip code
- 28576
- Applicant
- Mediclus Co., Ltd.
- Decision date
- 2026-07-21
- Decision code
- SESE
- Country code
- KR
- Device name
- One-Fil LC
- Advisory committee
- DE
- Contact
- Ku Da Hyeon
- K number
- K261728
- Date received
- 2026-05-26
- Review advisory committee
- DE
- Postal code
- 28576
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Liner, Cavity, Calcium Hydroxide
- Medical specialty description
- Dental
- Regulation number
- 872.3250
- Device class
- 2
- Registration number
- 2433629, 3004569445, 2411797, 8030938, 3031841433, 3012421607, 3016447764, 2515379, 3032911850, 9680144, 3012187973, 1000492377, 2241860, 3003120666, 3044819802, 3045857207, 9681210, 3038718579, 3013584861, 3012502601, 3009560600, 3005176727, 3032163716, 3002807420, 2022039, 3006113314, 9611385, 3023816720, 3012494290, 3008966075, 3012996495, 9612300, 3042272797, 2024312, 1281412, 3010407924, 8010908, 3043226252, 2219920, 3002807050 +10 more
- FEI number
- 2433629, 3004569445, 2411797, 3031841433, 3012421607, 3016447764, 3003667632, 2515379, 3032911850, 3012187973, 1000492377, 2241860, 3003120666, 3044819802, 3045857207, 3038718579, 3013584861, 3012502601, 3009560600, 3005176727, 3002718942, 3032163716, 3002807420, 2022039, 3006113314, 3023816720, 3002808289, 3012494290, 3008966075, 3012996495, 3002729120, 3004586882, 3042272797, 2024312, 1281412, 3010407924, 3002806930, 3043226252, 2219920, 3002807050 +10 more