Device classification

Coating, Filling Material, Resin

Dental · 21 CFR 872.3310

Class IIProduct code EBD
Open FDA's page for this record
Third party flag
Y
Life sustain support flag
N
Gmp exempt flag
N
Summary malfunction reporting
Eligible
Product code
EBD
Review panel
DE
Medical specialty
DE
Device name
Coating, Filling Material, Resin
Medical specialty description
Dental
Device class
2
Regulation number
872.3310
Implant flag
N
Submission type ID
1
Harmonized identifiers (openFDA)
K number
K240735, K250804, K992067, K791078, K862590, K073243, K021503, K823732, K850610, K013179, K850675, K082285, K904135, K935689, K850641, K162408, K024046, K070306, K163568, K840751, K080549, K254091, K123761, K850073, K810813, K790438, K822869, K974494, K822714, K854957, K984037, K781345, K844845, K052462, K223365, K030646, K760419, K030354, K791067, K813328 +12 more
Registration number
3005665377, 2086043, 3012187973, 9611385, 1410097, 3002789526, 3014579161, 2241860, 1000625496, 3012421607, 3045857207, 2424472, 8010908, 3002807050, 1215305, 3008912871, 1000303432, 1420089, 3002808149, 2515379, 1450653, 3044819802, 3014270094, 1420052, 2022039, 3009496224, 3035693034, 8044164, 1000118628, 3006694515, 9612300, 2411797, 2916735, 3006942327, 9610902, 3038718579, 1721647, 3004146043, 3039359767, 1000486347 +5 more
FEI number
3005665377, 3002808636, 3012187973, 1410097, 3002718942, 3002789526, 3014579161, 2241860, 3012421607, 3045857207, 3002807050, 3002088145, 1215305, 3004150030, 3002806930, 4838, 3002807166, 3008912871, 1000303432, 1420089, 3002808149, 2515379, 1450653, 3044819802, 3014270094, 1420052, 2022039, 3009496224, 3035693034, 1000118628, 3000719964, 3006694515, 2411797, 2916735, 3002808289, 3006942327, 3038718579, 1721647, 3004146043, 3039359767 +5 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.