510(k) clearances

Cerasmart Forte

GC America, Inc. · Dental

K262202Substantially EquivalentTraditionalEBF
Open FDA's page for this record
Third party flag
N
City
Alsip
Advisory committee description
Dental
Address 1
3737 W. 127th St.
Statement or summary
Summary
Product code
EBF
Zip code
60803
Applicant
GC America, Inc.
Decision date
2026-09-10
Decision code
SESE
Country code
US
Device name
Cerasmart Forte
Advisory committee
DE
Contact
Futoshi Fusejima
K number
K262202
State
IL
Date received
2026-06-29
Review advisory committee
DE
Postal code
60803
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.