Kavo America FDA Record
- Latest inspection NAI · Apr 30, 2009
- No warning letters matched by name
Kavo America has 0 FDA recalls, 1 inspection, 24 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Kavo America" is on file.
- Latest inspection
- Apr 30, 2009 · NAI
- Latest 510(k)
- Jul 10, 2008
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 24 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 1 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Apr 30, 2009 | Lake Zurich, IL | Devices | No Action Indicated (NAI) | 1419798 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 1419798 | Lake Zurich, IL | 1 | Apr 30, 2009 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K073074 | KEY LASER III 1243 US WITH DETECT | Jul 10, 2008 |
| K072262 | GENTLERAY 980 DIODE LASER SYSTEM | Oct 26, 2007 |
| K063624 | KAVO EVEREST C-TEMP | Feb 8, 2007 |
| K051909 | DIAGNODENT | Oct 21, 2005 |
| K030146 | KAVO KEY LASER 1242 AND KAVO KEY LASER 1243+ | Aug 3, 2005 |
| K042394 | DIAGNODENT PERIO TIP (ACCESSORY) | Aug 2, 2005 |
| K050744 | KAVO ERGOCOM/ERGOCAM | Apr 21, 2005 |
| K050019 | IN EXAM INTRAORAL DENTAL X-RAY SYSTEM | Jan 31, 2005 |
| K042872 | RONDOFLEX PLUS 360 | Nov 23, 2004 |
| K033221 | KAVO EVEREST ZH-BLANK | Oct 28, 2003 |
| K032081 | KAVO EVEREST ZS-BLANK MODELS, 42, 20, AND 60 | Jul 24, 2003 |
| K031868 | PROPHYPEARLS | Jul 9, 2003 |
| K030607 | KAVO EVEREST G-BLANK, KAVO EVEREST G-CERAM, COATING CERAMIC LF-3-PFM, GLAZE AND… | May 2, 2003 |
| K024214 | KAVO EVEREST TITANBLANK | Mar 12, 2003 |
| K012308 | KAVO QUATTROCARE | Jun 26, 2002 |
| K013500 | KAVO POLYLUX II | Jan 14, 2002 |
| K002708 | KAVO CORUND HANDPIECE 2013 | Nov 28, 2000 |
| K000805 | KAVO K.E.Y. LASER 1242 | May 4, 2000 |
| DEN990002 | KAVO DIAGNODENT | Feb 22, 2000 |
| K983100 | KAVO KEY LASER 1242 | Jan 27, 1999 |
Kavo America and the FDA: common questions
Has Kavo America received an FDA warning letter?
No FDA warning letter addressed to the name "Kavo America" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Kavo America received an FDA Form 483?
FDA has not published a Form 483 for "Kavo America" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Kavo America?
The most recent FDA inspection on file ended Apr 30, 2009 at Lake Zurich, IL and was classified NAI. FDA has 1 inspection of Kavo America on file.
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