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BellaTek Bars (K260940): 510(k) cleared for ZimVie US Corp, LLC vs Yomi S Robotic System (K261321): 510(k) cleared for Neocis, Inc.: FDAPulse comparison

BellaTek Bars (K260940): 510(k) cleared for ZimVie US Corp, LLC's review days of 185 is 1.1x Yomi S Robotic System (K261321): 510(k) cleared for Neocis, Inc.'s 174 (65th percentile). BellaTek Bars (K260940): 510(k) cleared for ZimVie US Corp, LLC is dated 2026-09-21; Yomi S Robotic System (K261321): 510(k) cleared for Neocis, Inc. 2026-10-13.

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

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How does BellaTek Bars (K260940): 510(k) cleared for ZimVie US Corp, LLC compare to Yomi S Robotic System (K261321): 510(k) cleared for Neocis, Inc.?

FieldBellaTek Bars (K260940): 510(k) cleared for ZimVie US Corp, LLCYomi S Robotic System (K261321): 510(k) cleared for Neocis, Inc.
Record510(k) clearance510(k) clearance
510(k) numberK260940K261321
DeviceBellaTek BarsYomi S Robotic System
ApplicantZimVie US Corp, LLCNeocis, Inc.
Specialty / panelDentalDental
Product codeNHAQRY
Device class22
Clearance typeSpecialTraditional
DecisionSubstantially EquivalentSubstantially Equivalent
Received2026-03-202026-04-22
Decision date2026-09-212026-10-13
Review time (days)185174
Third-party reviewNoNo
Applicant locationPalm Beach Gardens, FL, USMiami, FL, US
amount percentile65th62nd
Predicate Speed & CAPA Advisory Opportunity Score53/10048/100
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Official records: BellaTek Bars (K260940): 510(k) cleared for ZimVie US Corp, LLC · Yomi S Robotic System (K261321): 510(k) cleared for Neocis, Inc.

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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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