Comfort Acrylics Co.

FDA Regulatory Profile

Comfort Acrylics Co. has 0 FDA recalls, 4 inspections, 3 510(k) clearances and 0 compliance actions on record.

Latest inspection
Apr 19, 2019 · NAI
Latest 510(k)
Jan 11, 2019

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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) clearances3Oct 4, 2026Not statedCurrent
Inspections4Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Apr 19, 2019Camas, WADevicesNo Action Indicated (NAI)1000125917
Jan 7, 2015Camas, WADevicesVoluntary Action Indicated (VAI)1000125917
Jan 8, 2013Camas, WADevicesNo Action Indicated (NAI)1000125917
Mar 18, 2011Camas, WADevicesNo Action Indicated (NAI)1000125917

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
K182202SLEEPAPPJan 11, 2019
K910795COMFOR-DENT DENTURE LINERJul 11, 1991
K900799COMFORT ACRYLICS PLIABLE DENTURE LINERS & SPLINTSMay 15, 1990