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MOWANA™ Auto Duo (K261266): 510(k) cleared for PENTAMASTER MEDIQ SDN BHD vs S.I.N. Instruments Kits (K262084): 510(k) cleared for S.I.N. Implant System Ltda: FDAPulse comparison

MOWANA™ Auto Duo (K261266): 510(k) cleared for PENTAMASTER MEDIQ SDN BHD's review days of 154 is 1.3x S.I.N. Instruments Kits (K262084): 510(k) cleared for S.I.N. Implant System Ltda's 122 (57th percentile). MOWANA™ Auto Duo (K261266): 510(k) cleared for PENTAMASTER MEDIQ SDN BHD is dated 2026-09-17; S.I.N. Instruments Kits (K262084): 510(k) cleared for S.I.N. Implant System Ltda 2026-10-22.

Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)

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How does MOWANA™ Auto Duo (K261266): 510(k) cleared for PENTAMASTER MEDIQ SDN BHD compare to S.I.N. Instruments Kits (K262084): 510(k) cleared for S.I.N. Implant System Ltda?

FieldMOWANA™ Auto Duo (K261266): 510(k) cleared for PENTAMASTER MEDIQ SDN BHDS.I.N. Instruments Kits (K262084): 510(k) cleared for S.I.N. Implant System Ltda
Record510(k) clearance510(k) clearance
510(k) numberK261266K262084
DeviceMOWANA™ Auto DuoS.I.N. Instruments Kits
ApplicantPENTAMASTER MEDIQ SDN BHDS.I.N. Implant System Ltda
Specialty / panelGeneral HospitalGeneral Hospital
Product codeFMIKCT
Device class22
Clearance typeTraditionalTraditional
DecisionSubstantially EquivalentSubstantially Equivalent
Received2026-04-162026-06-22
Decision date2026-09-172026-10-22
Review time (days)154122
Third-party reviewYesNo
Applicant locationSimpang Ampat, MYSão Paulo, BR
amount percentile57th45th
Predicate Speed & CAPA Advisory Opportunity Score47/10042/100
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Official records: MOWANA™ Auto Duo (K261266): 510(k) cleared for PENTAMASTER MEDIQ SDN BHD · S.I.N. Instruments Kits (K262084): 510(k) cleared for S.I.N. Implant System Ltda

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Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.

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