Cosmedent, Inc. FDA Record
- Latest inspection NAI · Jun 7, 2017
- No warning letters matched by name
Cosmedent, Inc. has 2 FDA recalls, 5 inspections, 28 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Cosmedent, Inc." is on file.
- Latest recall
- Z-0211-2024 · Class II · Jul 20, 2023
- Latest inspection
- Jun 7, 2017 · NAI
- Latest 510(k)
- Jul 24, 2024
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 2 | Nov 11, 2026 (checked Nov 15, 2026, unchanged) | File dated Nov 10, 2026 | Current |
| 510(k) clearances | 28 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 5 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
Cosmedent, Inc.: FDA inspections per year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 1 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 1 | 0 | 0 | 1 | 0 |
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Recent recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0211-2024 | Class II | Cosmedent FlexiCup Composite Finishing & Polishing System, Six Pack, Autoclavable Aluminum Oxide… | Jul 20, 2023 |
| Z-0741-2018 | Class II | Cosmedent's Etching Gel, 3g, 37% Phosphoric Acid, Rx only. Packaged in 3g Luer Lock syringes… | Sep 28, 2017 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jun 7, 2017 | Chicago, IL | Devices | No Action Indicated (NAI) | 1450653 |
| Feb 24, 2014 | Chicago, IL | Devices | Voluntary Action Indicated (VAI) | 1450653 |
| Mar 10, 2011 | Chicago, IL | Devices | No Action Indicated (NAI) | 1450653 |
| Mar 10, 2011 | Chicago, IL | Devices | No Action Indicated (NAI) | 1450653 |
| Jun 11, 2009 | Chicago, IL | Devices | Voluntary Action Indicated (VAI) | 1450653 |
- 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 1450653 | Chicago, IL | 5 | Jun 7, 2017 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K240714 | Insure® Universal; Insure® Universal Automix | Jul 24, 2024 |
| K222435 | Renamel® Microhybrid ;Renamel® Flowable Microhybrid | Oct 11, 2022 |
| K211259 | Renamel Bulkfill | Jun 24, 2021 |
| K172707 | Renamel Microfill | Dec 5, 2017 |
| K163480 | Renamel NANO +plus | Feb 24, 2017 |
| K092730 | COSMEDENT BRUSHABLE COMPOSITE | Nov 20, 2009 |
| K070583 | NANO COMPOSITE | Apr 16, 2007 |
| K060881 | TEMPORARY CROWN & BRIDGE RESIN | May 16, 2006 |
| K052263 | MULTIPLE (TOOTH DESENSITIZER) | Dec 16, 2005 |
| K052501 | MULTIPLE RESIN TOOTH BONDING AGENT | Oct 21, 2005 |
| K042823 | COSMEDENT PIT & FISSURE SEALANT | Dec 1, 2004 |
| K041229 | MULTIPLE (ADDITION SILICONE IMPRESSION MATERIAL) | Jun 17, 2004 |
| K040994 | COSMEDENT CORE PASTE | Jun 3, 2004 |
| K030832 | PRIMOSPLINT SYSTEM | Sep 17, 2003 |
| K011239 | GINDA GUARD | Feb 14, 2002 |
| K993659 | RENAMEL PACK | Jan 18, 2000 |
| K993658 | RENAMEL SCULPT | Jan 18, 2000 |
| K980800 | LOW VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIAL | Nov 9, 1998 |
| K980799 | HIGH VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIAL | Oct 28, 1998 |
| K980298 | FLOWABLE HYBRID | Mar 9, 1998 |
Cosmedent, Inc. and the FDA: common questions
Has Cosmedent, Inc. received an FDA warning letter?
No FDA warning letter addressed to the name "Cosmedent, Inc." 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 Cosmedent, Inc. received an FDA Form 483?
FDA has not published a Form 483 for "Cosmedent, Inc." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Cosmedent, Inc.?
The most recent FDA inspection on file ended Jun 7, 2017 at Chicago, IL and was classified NAI. FDA has 5 inspections of Cosmedent, Inc. on file.
Has Cosmedent, Inc. had an FDA recall?
Yes. Cosmedent, Inc. has 2 FDA recalls on record. The most recent started Jul 20, 2023.
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