One-Fil
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
- KIF
- Applicant
- Mediclus Co., Ltd.
- Decision date
- 2024-01-26
- Decision code
- SESE
- Country code
- KR
- Device name
- One-Fil
- Advisory committee
- DE
- Contact
- Priscilla Chung
- K number
- K232182
- Date received
- 2023-07-24
- Review advisory committee
- DE
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Resin, Root Canal Filling
- Medical specialty description
- Dental
- Regulation number
- 872.3820
- Device class
- 2
- Registration number
- 9615399, 3005831677, 3021971019, 3005628474, 3012187973, 9616142, 1410097, 8010908, 2436986, 2429849, 3012421607, 1413475, 3045857207, 3003120666, 9616128, 3011824442, 8010638, 1215305, 9680845, 1032227, 3023816720, 8020994, 3016447764, 3026400121, 3003449480, 3032312561, 2416455, 3013557697, 3004425647, 3004443427, 3008912871, 3012354669, 8010629, 3008822460, 3030405669, 8010468, 2320721, 3004748528, 3044819802, 8010414 +36 more
- FEI number
- 3005831677, 3001180585, 3021971019, 3005628474, 3004586882, 3010138769, 3012187973, 1410097, 3002718942, 1000231788, 2429849, 3012421607, 1413475, 3045857207, 3003120666, 3011824442, 3000368601, 1215305, 3004724816, 1032227, 3026400121, 3023816720, 3016447764, 5615, 3003449480, 3002807929, 3032312561, 2416455, 3013557697, 1000554802, 3004425647, 3004443427, 3008912871, 3012354669, 3008822460, 3003667632, 3030405669, 3002574147, 3004748528, 3005907356 +36 more