510(k) clearances

Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)

Guilin Kevin Peter Technology Co., Ltd. · Dental

K261695Substantially EquivalentTraditionalEBF
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
EBF
Zip code
541100
Applicant
Guilin Kevin Peter Technology Co., Ltd.
Decision date
2026-08-31
Decision code
SESE
Country code
CN
Device name
Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)
Advisory committee
DE
Contact
Qian Zhang
K number
K261695
Date received
2026-05-22
Review advisory committee
DE
Postal code
541100
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Material, Tooth Shade, Resin
Medical specialty description
Dental
Regulation number
872.3690
Device class
2
Registration number
3018507299, 3010864832, 3014683120, 3017674095, 3006316962, 3039433962, 2027375, 2515379, 1424442, 2133714, 3011944170, 2241860, 3026400121, 8044038, 3015527825, 3038715999, 2024980, 3009907932, 2022039, 9613375, 1420089, 2126683, 3003621174, 9613953, 3011814610, 3010664129, 9613348, 3009482106, 3009582362, 3014615644, 3015978392, 3003114027, 8030067, 3043226252, 3013012934, 3024749697, 3011511773, 3005628474, 3032312561, 3038295269 +170 more
FEI number
3018507299, 3014683120, 3017674095, 3006316962, 3002806620, 3039433962, 2027375, 2515379, 3010862763, 3011944170, 2241860, 3026400121, 3008875470, 4838, 3015527825, 3038715999, 3000719964, 3009907932, 2022039, 1420089, 2126683, 3003621174, 3002808289, 3011814610, 3010664129, 3009482106, 3009582362, 3014615644, 3015978392, 3002807052, 3003114027, 3002806930, 3043226252, 3013012934, 3024749697, 3011511773, 3002088145, 3001027751, 3005628474, 3032312561 +170 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.