510(k) clearances

Calcium Hydroxide Temporary Filling Material (KP-Cal)

Guilin Kevin Peter Technology Co., Ltd. · Dental

K261514Substantially EquivalentTraditionalKIF
Open FDA's page for this record
Third party flag
N
City
Guilin
Advisory committee description
Dental
Address 1
North Side Of Linsu Rd., Lingui Town, Lingui Dist.
Statement or summary
Summary
Product code
KIF
Zip code
541100
Applicant
Guilin Kevin Peter Technology Co., Ltd.
Decision date
2026-08-25
Decision code
SESE
Country code
CN
Device name
Calcium Hydroxide Temporary Filling Material (KP-Cal)
Advisory committee
DE
Contact
Libin Zhang
K number
K261514
Date received
2026-05-07
Review advisory committee
DE
Postal code
541100
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
3002807757, 2433629, 8030962, 2411797, 8010414, 8030938, 2416455, 3012421607, 3016447764, 9616128, 1718912, 1721647, 2133714, 3030405669, 1000492377, 3012187973, 3000219976, 3003120666, 3012627824, 3044819802, 9681210, 3012477813, 3013584861, 3027344570, 3009560600, 3012354669, 3011824442, 9680845, 3026400121, 3038718579, 3004425647, 3004748528, 9615399, 9681254, 3009130085, 1410097, 3006113314, 2183301, 3035983708, 3023816720 +36 more
FEI number
3002807757, 2433629, 2411797, 5615, 2416455, 3012421607, 3016447764, 3010138769, 3002718942, 3003667632, 1718912, 3002806577, 1721647, 3030405669, 1000492377, 3012187973, 3000219976, 3003120666, 3012627824, 3044819802, 3038718579, 3012477813, 3013584861, 3027344570, 3009560600, 3012354669, 3011824442, 3001180585, 3005907356, 3026400121, 3000209941, 3004425647, 3004748528, 1000477999, 3009130085, 1410097, 3006113314, 2183301, 3035983708, 3023816720 +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.