Almitech, Inc.
FDA Regulatory Profile
Almitech, Inc. has 0 FDA recalls, 5 inspections, 1 510(k) clearance and 0 compliance actions on record.
- Latest inspection
- Apr 18, 2019 · NAI
- Latest 510(k)
- Dec 22, 2005
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 0 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 1 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 5 | Nov 9, 2026 | Newest record Oct 28, 2026 | Current |
|---|
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Apr 18, 2019 | Bellmore, NY | Devices | No Action Indicated (NAI) | 3005562016 |
| Mar 30, 2018 | Bellmore, NY | Devices | Official Action Indicated (OAI) | 3005562016 |
| Jun 18, 2015 | Bellmore, NY | Devices | No Action Indicated (NAI) | 3005562016 |
| Jun 17, 2011 | Bellmore, NY | Devices | No Action Indicated (NAI) | 3005562016 |
| Apr 21, 2009 | Bellmore, NY | Devices | No Action Indicated (NAI) | 3005562016 |
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.
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|
| FEI 3005562016 | Bellmore, NY | 5 | Apr 18, 2019 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K052733 | ALMITECH INC. DENTAL IMPLANT SYSTEM | Dec 22, 2005 |