Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cosmedent, Inc. · Predicate Candidate Screening
28 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
77 daysmedian FDA review time
252 days90th percentile
28clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240714 | Insure® Universal; Insure® Universal Automix | Cosmedent, Inc. | 2024-07-24 | 131 | 0 |
| K222435 | Renamel® Microhybrid ;Renamel® Flowable Microhybrid | Cosmedent, Inc. | 2022-10-11 | 60 | 0 |
| K211259 | Renamel Bulkfill | Cosmedent, Inc. | 2021-06-24 | 59 | 0 |
| K172707 | Renamel Microfill | Cosmedent, Inc. | 2017-12-05 | 88 | 0 |
| K163480 | Renamel NANO +plus | Cosmedent, Inc. | 2017-02-24 | 74 | 0 |
| K092730 | COSMEDENT BRUSHABLE COMPOSITE | Cosmedent, Inc. | 2009-11-20 | 77 | 0 |
| K070583 | NANO COMPOSITE | Cosmedent, Inc. | 2007-04-16 | 46 | 0 |
| K060881 | TEMPORARY CROWN & BRIDGE RESIN | Cosmedent, Inc. | 2006-05-16 | 46 | 0 |
| K052263 | MULTIPLE (TOOTH DESENSITIZER) | Cosmedent, Inc. | 2005-12-16 | 119 | 0 |
| K052501 | MULTIPLE RESIN TOOTH BONDING AGENT | Cosmedent, Inc. | 2005-10-21 | 38 | 0 |
| K042823 | COSMEDENT PIT & FISSURE SEALANT | Cosmedent, Inc. | 2004-12-01 | 50 | 0 |
| K041229 | MULTIPLE (ADDITION SILICONE IMPRESSION MATERIAL) | Cosmedent, Inc. | 2004-06-17 | 38 | 0 |
| K040994 | COSMEDENT CORE PASTE | Cosmedent, Inc. | 2004-06-03 | 48 | 0 |
| K030832 | PRIMOSPLINT SYSTEM | Cosmedent, Inc. | 2003-09-17 | 184 | 0 |
| K011239 | GINDA GUARD | Cosmedent, Inc. | 2002-02-14 | 297 | 0 |
| K993658 | RENAMEL SCULPT | Cosmedent, Inc. | 2000-01-18 | 81 | 0 |
| K993659 | RENAMEL PACK | Cosmedent, Inc. | 2000-01-18 | 81 | 0 |
| K980800 | LOW VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIAL | Cosmedent, Inc. | 1998-11-09 | 252 | 0 |
| K980799 | HIGH VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIAL | Cosmedent, Inc. | 1998-10-28 | 240 | 0 |
| K980298 | FLOWABLE HYBRID | Cosmedent, Inc. | 1998-03-09 | 41 | 0 |
| K974494 | RENAMEL FLOWABLE COMPOSITE | Cosmedent, Inc. | 1998-02-10 | 74 | 0 |
| K924132 | E.Z. TEMEP, TEMPORARY FILLING MATERIAL | Cosmedent, Inc. | 1993-07-08 | 325 | 0 |
| K921820 | RENAMEL ESTHETIC RESTORATIVE SYSTEM, MODIFICATION | Cosmedent, Inc. | 1992-06-16 | 63 | 0 |
| K894477 | INSURE MATCH MATE PORCELAIN VENEER TRY-IN SYSTEM | Cosmedent, Inc. | 1990-01-10 | 176 | 0 |
| K894994 | DENTIN BONDING SYSTEM | Cosmedent, Inc. | 1989-10-24 | 77 | 0 |
| K873356 | INSURE PORCELAIN VENEER BONDING SYSTEM | Cosmedent, Inc. | 1987-12-29 | 131 | 0 |
| K862912 | RENAMELIZE POLISHING PASTE | Cosmedent, Inc. | 1986-08-12 | 11 | 0 |
| K854755 | RENAMEL ESTHETIC RESTORATIVE SYSTEM | Cosmedent, Inc. | 1986-03-13 | 106 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda