Altatec GmbH

FDA Regulatory Profile

Altatec GmbH has 0 FDA recalls, 1 inspection, 14 510(k) clearances and 0 compliance actions on record.

Latest inspection
Dec 8, 2014 · NAI
Latest 510(k)
Sep 29, 2020

Reviewing Altatec GmbH as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.

Request a free FDA snapshot

Or get Altatec GmbH's full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site, in Claude, Cursor or ChatGPT.

Get a free API key

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances14Oct 4, 2026Not statedCurrent
Inspections1Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Dec 8, 2014Wimsheim, GermanyDevicesNo Action Indicated (NAI)3002806355

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
K193401Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE ImplantsSep 29, 2020
K160784CAM Titanium BlanksSep 14, 2016
K153779Abutment for BridgesMar 31, 2016
K152509CAMLOG and CONELOG Abutments for Screw-retained Restorations (ASR)Jan 12, 2016
K151599iSy Implant SystemOct 2, 2015
K143337CONELOG Titanium base CAD/CAMFeb 17, 2015
K133991ISYAug 6, 2014
K113779CONELOG IMPLANT SYSTEMDec 14, 2012
K103252CAMLOG VARIO SR ABUTMENTSJan 10, 2011
K090347CAMLOG ABUTMENTS PSJun 18, 2009
K083496CAMLOG IMPLANT SYSTEM MODIFIED IMPLANTS AND ABUTMENTSJan 30, 2009
K073553CAMLOG IMPLANT SYSTEM ABUTMENTSMar 5, 2008
K071213CAMLOG LOGFIT PROSTHETIC SYSTEMAug 10, 2007
K051636CAMLOG DENTAL IMPLANT ABUTMENTS, HEALING CAPS, AND ACCESSORIESFeb 17, 2006