Company · US
Cosmedent, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1986 to 2024. Name variants (Inc, Corp, punctuation) are merged.
28510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| EBF | Material, Tooth Shade, Resin | 12 |
| EMA | Cement, Dental | 4 |
| EBD | Coating, Filling Material, Resin | 3 |
| KLE | Agent, Tooth Bonding, Resin | 3 |
| EBG | Crown And Bridge, Temporary, Resin | 2 |
| EBC | Sealant, Pit And Fissure, And Conditioner | 1 |
| EHK | Cup, Prophylaxis | 1 |
| EJR | Agent, Polishing, Abrasive, Oral Cavity | 1 |
| ELW | Material, Impression | 1 |
| LBH | Varnish, Cavity | 1 |
| MQC | Mouthguard, Prescription | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 24, 2024 | K240714 | Insure® Universal; Insure® Universal Automix Cosmedent, Inc. | EMA |
| Oct 11, 2022 | K222435 | Renamel® Microhybrid ;Renamel® Flowable Microhybrid Cosmedent, Inc. | EBF |
| Jun 24, 2021 | K211259 | Renamel Bulkfill Cosmedent, Inc. | EBF |
| Dec 5, 2017 | K172707 | Renamel Microfill Cosmedent, Inc. | EBF |
| Feb 24, 2017 | K163480 | Renamel NANO +plus Cosmedent, Inc. | EBF |
| Nov 20, 2009 | K092730 | COSMEDENT BRUSHABLE COMPOSITE Cosmedent, Inc. | EBF |
| Apr 16, 2007 | K070583 | NANO COMPOSITE Cosmedent, Inc. | EBF |
| May 16, 2006 | K060881 | TEMPORARY CROWN & BRIDGE RESIN Cosmedent, Inc. | EBG |
| Dec 16, 2005 | K052263 | MULTIPLE (TOOTH DESENSITIZER) Cosmedent, Inc. | LBH |
| Oct 21, 2005 | K052501 | MULTIPLE RESIN TOOTH BONDING AGENT Cosmedent, Inc. | KLE |
| Dec 1, 2004 | K042823 | COSMEDENT PIT & FISSURE SEALANT Cosmedent, Inc. | EBC |
| Jun 17, 2004 | K041229 | MULTIPLE (ADDITION SILICONE IMPRESSION MATERIAL) Cosmedent, Inc. | ELW |
| Jun 3, 2004 | K040994 | COSMEDENT CORE PASTE Cosmedent, Inc. | EBF |
| Sep 17, 2003 | K030832 | PRIMOSPLINT SYSTEM Cosmedent, Inc. | MQC |
| Feb 14, 2002 | K011239 | GINDA GUARD Cosmedent, Inc. | EBD |
| Jan 18, 2000 | K993659 | RENAMEL PACK Cosmedent, Inc. | EBF |
| Jan 18, 2000 | K993658 | RENAMEL SCULPT Cosmedent, Inc. | EBF |
| Nov 9, 1998 | K980800 | LOW VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIAL Cosmedent, Inc. | EBF |
| Oct 28, 1998 | K980799 | HIGH VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIAL Cosmedent, Inc. | EBG |
| Mar 9, 1998 | K980298 | FLOWABLE HYBRID Cosmedent, Inc. | EBD |
| Feb 10, 1998 | K974494 | RENAMEL FLOWABLE COMPOSITE Cosmedent, Inc. | EBD |
| Jul 8, 1993 | K924132 | E.Z. TEMEP, TEMPORARY FILLING MATERIAL Cosmedent, Inc. | EMA |
| Jun 16, 1992 | K921820 | RENAMEL ESTHETIC RESTORATIVE SYSTEM, MODIFICATION Cosmedent, Inc. | EBF |
| Jan 10, 1990 | K894477 | INSURE MATCH MATE PORCELAIN VENEER TRY-IN SYSTEM Cosmedent, Inc. | EMA |
| Oct 24, 1989 | K894994 | DENTIN BONDING SYSTEM Cosmedent, Inc. | KLE |
| Dec 29, 1987 | K873356 | INSURE PORCELAIN VENEER BONDING SYSTEM Cosmedent, Inc. | EMA |
| Aug 12, 1986 | K862912 | RENAMELIZE POLISHING PASTE Cosmedent, Inc. | EJR |
| Mar 13, 1986 | K854755 | RENAMEL ESTHETIC RESTORATIVE SYSTEM Cosmedent, Inc. | EBF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 2, 2023 | Cosmedent, Inc. Cosmedent FlexiCup Composite Finishing & Polishing System, Six Pack, Autoclavable Aluminum Oxide Polishing Instrument, Medium (Blue), REF #403-101, Rx. Open, Classified |
EHK | None listed |
| Sep 28, 2017 | Cosmedent, Inc. Cosmedent's Etching Gel, 3g, 37% Phosphoric Acid, Rx only. Packaged in 3g Luer Lock syringes.
Used for etching enamel and dentin. Terminated |
KLE | K052501 |