Cosmedent, Inc.
Chicago, IL, US
COSMEDENT, INC. appears in FDA device records in Chicago, IL. FDA records list 28 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 28 510(k) clearances for Cosmedent, Inc. between 1986 and 2024. The busiest year on record is 1998, with 4. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1986 | 2 |
| 1987 | 1 |
| 1989 | 1 |
| 1990 | 1 |
| 1992 | 1 |
| 1993 | 1 |
| 1998 | 4 |
| 2000 | 2 |
| 2002 | 1 |
| 2003 | 1 |
| 2004 | 3 |
| 2005 | 2 |
| 2006 | 1 |
| 2007 | 1 |
| 2009 | 1 |
| 2017 | 2 |
| 2021 | 1 |
| 2022 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K240714 | Insure® Universal; Insure® Universal Automix | EMA | Substantially Equivalent | |
| K222435 | Renamel® Microhybrid ;Renamel® Flowable Microhybrid | EBF | Substantially Equivalent | |
| K211259 | Renamel Bulkfill | EBF | Substantially Equivalent | |
| K172707 | Renamel Microfill | EBF | Substantially Equivalent | |
| K163480 | Renamel NANO +plus | EBF | Substantially Equivalent | |
| K092730 | COSMEDENT BRUSHABLE COMPOSITE | EBF | Substantially Equivalent | |
| K070583 | NANO COMPOSITE | EBF | Substantially Equivalent | |
| K060881 | TEMPORARY CROWN & BRIDGE RESIN | EBG | Substantially Equivalent | |
| K052263 | MULTIPLE (TOOTH DESENSITIZER) | LBH | Substantially Equivalent | |
| K052501 | MULTIPLE RESIN TOOTH BONDING AGENT | KLE | Substantially Equivalent | |
| K042823 | COSMEDENT PIT & FISSURE SEALANT | EBC | Substantially Equivalent | |
| K041229 | MULTIPLE (ADDITION SILICONE IMPRESSION MATERIAL) | ELW | Substantially Equivalent | |
| K040994 | COSMEDENT CORE PASTE | EBF | Substantially Equivalent | |
| K030832 | PRIMOSPLINT SYSTEM | MQC | Substantially Equivalent | |
| K011239 | GINDA GUARD | EBD | Substantially Equivalent | |
| K993659 | RENAMEL PACK | EBF | Substantially Equivalent | |
| K993658 | RENAMEL SCULPT | EBF | Substantially Equivalent | |
| K980800 | LOW VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIAL | EBF | Substantially Equivalent | |
| K980799 | HIGH VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIAL | EBG | Substantially Equivalent | |
| K980298 | FLOWABLE HYBRID | EBD | Substantially Equivalent | |
| K974494 | RENAMEL FLOWABLE COMPOSITE | EBD | Substantially Equivalent | |
| K924132 | E.Z. TEMEP, TEMPORARY FILLING MATERIAL | EMA | Substantially Equivalent | |
| K921820 | RENAMEL ESTHETIC RESTORATIVE SYSTEM, MODIFICATION | EBF | Substantially Equivalent | |
| K894477 | INSURE MATCH MATE PORCELAIN VENEER TRY-IN SYSTEM | EMA | Substantially Equivalent | |
| K894994 | DENTIN BONDING SYSTEM | KLE | Substantially Equivalent | |
| K873356 | INSURE PORCELAIN VENEER BONDING SYSTEM | EMA | Substantially Equivalent | |
| K862912 | RENAMELIZE POLISHING PASTE | EJR | Substantially Equivalent | |
| K854755 | RENAMEL ESTHETIC RESTORATIVE SYSTEM | EBF | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1450653 | 1450653 | COSMEDENT, INC. | 4646 N. RAVENSWOOD AVE., CHICAGO, IL 60640 US | 2026 | and 14 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DYHAdhesive, Bracket And Tooth Conditioner, Resin
- EJRAgent, Polishing, Abrasive, Oral Cavity
- KLEAgent, Tooth Bonding, Resin
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- KXRApplicator, Resin
- EMACement, Dental
- EBDCoating, Filling Material, Resin
- EBGCrown And Bridge, Temporary, Resin
- EHKCup, Prophylaxis
- EHJDisk, Abrasive
- EHEDispenser, Mercury And/Or Alloy
- MAUEraser, Dental Stain
- EJBHandle, Instrument, Dental
- ELWMaterial, Impression
- EBFMaterial, Tooth Shade, Resin
- MQCMouthguard, Prescription
- EHLPoint, Abrasive
- JEPRetainer, Matrix
- EBCSealant, Pit And Fissure, And Conditioner
- EHMStrip, Polishing Agent
- EIDSyringe, Restorative And Impression Material
- EHYTray, Impression, Preformed
- FSMTray, Surgical, Instrument
- LBHVarnish, Cavity
- EJQWheel, Polishing Agent
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0211-2024 | Cosmedent FlexiCup Composite Finishing & Polishing System, Six Pack, Autoclavable Aluminum Oxide Polishing Instrument, Medium (Blue), REF #403-101, Rx. | Reports were received the elastomer cup material is crumbling. | Class II | Open, Classified | |
| Z-0741-2018 | Cosmedent's Etching Gel, 3g, 37% Phosphoric Acid, Rx only. Packaged in 3g Luer Lock syringes. Used for etching enamel and dentin. | Product packaged in a syringe that is not a lure lock syringe and the tip cold come off when expressing the material. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain