510(k) clearances

Microdent Sterilization Cassette

Implant Microdent System S.L.U. · General Hospital

K242023Substantially EquivalentTraditionalKCT
Open FDA's page for this record
Third party flag
N
City
Santa Eulalia De Ronçana
Advisory committee description
General Hospital
Address 1
C/Carles Bu"Igues, 1 1 Pol. Ind. Can Magre
Statement or summary
Summary
Product code
KCT
Zip code
08187
Applicant
Implant Microdent System S.L.U.
Decision date
2025-02-19
Decision code
SESE
Country code
ES
Device name
Microdent Sterilization Cassette
Advisory committee
HO
Contact
Joan Muñoz
K number
K242023
Date received
2024-07-11
Review advisory committee
HO
Postal code
08187
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Medical specialty description
General Hospital
Regulation number
880.6850
Device class
2
Registration number
8044099, 3010363542, 9610612, 3018094310, 3013114075, 3013247477, 3008868758, 3038187466, 8020776, 1062741, 8043792, 3014553709, 3015392401, 3016555232, 1057421, 3011824442, 3014409963, 3008837339, 3014421917, 3009538923, 3015612252, 9680261, 3012322232, 3007389669, 3005706667, 3011373951, 2184066, 3010707607, 9610773, 3026606306, 3036622014, 9612074, 3006742481, 1418479, 1314417, 3011063460, 3008864603, 3013111692, 3004203816, 3009050824 +258 more
FEI number
3010363542, 1000477302, 3018094310, 3013114075, 3013247477, 3008868758, 3038187466, 3014553709, 3003267134, 3015392401, 4224, 3016555232, 3011824442, 3014409963, 3008837339, 3014421917, 3009538923, 3015612252, 3012322232, 3007389669, 3005706667, 3011373951, 3002808269, 3010707607, 1000306694, 2523865, 3026606306, 3036622014, 1418479, 3006742481, 1000306303, 1314417, 3011063460, 3008864603, 3013111692, 3004203816, 3009050824, 1720499, 3008114965, 3003477135 +258 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.