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Sterngold Dental, LLC

FDA Regulatory Profile

Sterngold Dental, LLC has 0 FDA recalls, 1 inspection, 12 510(k) clearances and 0 compliance actions on record.

Latest inspection
Dec 8, 2010 · VAI
Latest 510(k)
Sep 28, 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) clearances12Oct 4, 2026Not statedCurrent
Inspections1Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Dec 8, 2010Attleboro, MADevicesVoluntary Action Indicated (VAI)2921595

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
K171728MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mmSep 28, 2017
K153173MOR Implant SystemFeb 5, 2016
K151928PUR Dental Implant SystemNov 6, 2015
K150968TRU Dental Implant SystemJul 24, 2015
K150250SternSnap Angled AttachmentJun 11, 2015
K142667Stern AC 3.3x10mm, Stern AC 3.3x11.5mm, Stern AC 3.3x13mm, Stern AC 4.0x8.5mm, Stern AC 4.0x10mmJan 7, 2015
K142407Straight Stud AttachmentDec 24, 2014
K133791ORA 0.4MM [S], ORA 1.0MM [S], ORA 2.0MM [S], ORA 3.0MM [S], ORA 4.0MM [S]Apr 16, 2014
K132814SFI-BAR IMPLANT ABUTMENTSFeb 25, 2014
K130183SFI BAR ABUTMENTSJul 7, 2013
K130408ERA MICRO 23 FEMALE ABUTMENT, ERA MICRO 30 FEMALE ABUTMENTJul 1, 2013
K111798STERNIC IMPLANT 4.2MM RN, 1.8MM, 8.0MM / 4.1MM RN, 1.8MM, 10.MM / 4.1 MM RN, 1.8MM, 12.0MM / 4.1MM…Jun 1, 2012

FDA data resources