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Takara Belmont Corporation

FDA Regulatory Profile

Takara Belmont Corporation has 0 FDA recalls, 1 inspection, 8 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jul 21, 2016 · VAI
Latest 510(k)
Mar 20, 2017

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances8Oct 4, 2026Not statedCurrent
Inspections1Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Jul 21, 2016Osaka, JapanDevicesVoluntary Action Indicated (VAI)3002808310

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K163175Bel-Cypher ProMar 20, 2017
K152100Evogue Dental UnitJan 22, 2016
K141293PHOT-X IIS MODEL 505Sep 3, 2014
K101181BEL-CATJul 19, 2011
K110160BEL-CYPHER NFeb 17, 2011
K093240BELRAY IIMar 22, 2010
K090020BEL-CYPHER, MODEL Y977Mar 13, 2009
K072574ALPHARD CONE BEAM CT, MODEL X178Oct 18, 2007

FDA data resources