510(k) clearances

Bioceramic Root Repair Material (C-Root BP)

Beijing C-Root Dental Medical Devices Co., Ltd. · Dental

K240365Substantially EquivalentTraditionalKIF
Open FDA's page for this record
Third party flag
N
City
Beijing
Advisory committee description
Dental
Address 1
Rm. 301, Bldg. 10, Yard 12
Address 2
Middle Juyuan Rd., Mapo Town, Shunyi
Statement or summary
Summary
Product code
KIF
Zip code
101300
Applicant
Beijing C-Root Dental Medical Devices Co., Ltd.
Decision date
2024-05-10
Decision code
SESE
Country code
CN
Device name
Bioceramic Root Repair Material (C-Root BP)
Advisory committee
DE
Contact
Bingmin Wu
K number
K240365
Date received
2024-02-06
Review advisory committee
DE
Postal code
101300
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
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.