Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
DYH — Predicate Candidate Screening
194 FDA 510(k) clearances under this product code; the 50 most recent screened below.
66 daysmedian FDA review time
154 days90th percentile
194clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261129 | OrthoFit | Spident Co., Ltd. | 2026-07-02 | 87 | 0 |
| K261840 | BracePaste Prime Plus | American Orthodontics | 2026-06-03 | 1 | 0 |
| K250015 | Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Prim | Ormco Corporation | 2025-01-03 | 1 | 0 |
| K242537 | BracePaste Fluoride Sealant | American Orthodontics Corp. | 2024-08-27 | 1 | 0 |
| K234043 | 3M™ Transbond™ Orthodontic Adhesive | 3M Unitek Orthodontic Products | 2023-12-22 | 1 | 0 |
| K231817 | AlignerFlow LC | Voco GmbH | 2023-12-01 | 163 | 0 |
| K214054 | TP Orthodontics Light-Cure Adhesive System, TP Orthodontics | Tp Orthodontics, Inc. | 2022-10-14 | 291 | 0 |
| K210115 | FiteBac CC OrthoSeal | Largent Health, LLC | 2021-07-29 | 191 | 0 |
| K202276 | BracePaste Band and Build LC | American Orthodontics | 2020-08-14 | 3 | 0 |
| K192682 | Orthocem, Ortho Bite | Dentscare Ltda | 2020-08-14 | 323 | 0 |
| K193388 | GlassLok Kits, GlassLok Powder, GlassLok Liquid | Reliance Orthodontic Products, Inc. | 2020-04-27 | 143 | 0 |
| K183147 | BrackFix | Voco GmbH | 2019-03-01 | 108 | 0 |
| K173020 | OBA-MCP, Orthodontic Bracket Adhesive with MCP | Pulpdent Corporation | 2018-01-17 | 111 | 0 |
| K160782 | BracePaste Adhesive | American Orthodontics | 2016-10-14 | 206 | 0 |
| K161684 | Quantum LB | Reliance Orthodontic Products, Inc. | 2016-10-06 | 111 | 0 |
| K150128 | GC Ortho Connect, GC Ortho Etching Gel | Gc Orthodontics America, Inc. | 2015-07-16 | 177 | 0 |
| K143667 | GC KommonBase | Gc Orthodontics America, Inc. | 2015-05-07 | 135 | 0 |
| K142886 | DMRC Self-Cure Bracket Adhesive One Step and Primer | Danville Materials, LLC | 2015-03-18 | 167 | 0 |
| K142881 | DMRC Dual Cure Orthodontic Band Cement | Danville Materials, LLC | 2015-02-13 | 134 | 0 |
| K142880 | DMRC Light Cure Orthodontic Adhesive System | Daville Materials, LLC | 2015-02-04 | 125 | 0 |
| K123348 | CLEAR ALIGNER ADHESIVE | Reliance Orthodontic Products, Inc. | 2013-02-28 | 120 | 0 |
| K120619 | ORTHODONTIC FLOWABLE BRACKET ADHESIVE | Novocol, Inc. | 2012-05-21 | 82 | 0 |
| K113401 | ORTHO-1(NOT FINALIZED) | Bisco, Inc. | 2012-02-07 | 82 | 0 |
| K113197 | APC FLASH-FREE ADHESIVE | 3M Unitek Corporation | 2012-02-02 | 94 | 0 |
| K111814 | PADLOCK | Reliance Orthodontic Products, Inc. | 2011-09-14 | 79 | 0 |
| K111696 | OPAL BAND CEMENT | Ultradent Products, Inc. | 2011-09-07 | 82 | 0 |
| K101951 | LIGHT CURE RETAINER | Reliance Orthodontic Products, Inc. | 2010-10-26 | 106 | 0 |
| K100536 | TRANSBOND IDB PRE-MIX CHEMICAL CARE ADHESIVE | 3M Unitek | 2010-07-27 | 152 | 0 |
| K100301 | OPAL BOND FLOW | Ultradent Products, Inc. | 2010-04-29 | 85 | 0 |
| K094006 | OPAL BOND MV | Ultradent Products, Inc. | 2010-03-23 | 85 | 0 |
| K093221 | PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION II | Dentsply Intl., Inc. | 2009-10-30 | 17 | 0 |
| K090355 | OPAL SEAL | Ultradent Products, Inc. | 2009-04-29 | 77 | 0 |
| K083051 | FLOWTAIN & FLOWTAIN LV | Reliance Orthodontic Products, Inc. | 2009-02-20 | 129 | 0 |
| K080445 | LION SE ONE STEP ORTHODONTIC ADHESIVE | Classone Orthodontics, Inc. | 2008-07-16 | 148 | 0 |
| K080724 | GC OPB-100 | GC America, Inc. | 2008-06-11 | 89 | 0 |
| K081291 | PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION | Dentsply Interntional | 2008-05-22 | 15 | 0 |
| K073588 | GC MODELS OPA-100 AND JC-50 | GC America, Inc. | 2008-02-15 | 57 | 0 |
| K073697 | TRANSBOND SUPREME ADHESIVE | 3M Unitek | 2008-02-15 | 46 | 0 |
| K072978 | TENDER ORTHO BOND-ENA BOND-ENA ETCH | Micerium S.P.A. | 2008-01-17 | 87 | 0 |
| K072830 | RM BOND, MODEL J032 | Pentron Clinical Technologies | 2007-12-04 | 62 | 0 |
| K071590 | THERMA-CURE | Reliance Orthodontic Products, Inc. | 2007-07-31 | 50 | 0 |
| K061252 | PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM | Primus Consulting | 2007-02-12 | 284 | 0 |
| K061481 | GRENGLOO | Ormco Corp. | 2006-07-06 | 37 | 1 |
| K053379 | RELI-ON ONE STEP, ORTHODONTIC ADHESIVE | Classone Orthodontics, Inc. | 2006-01-25 | 51 | 0 |
| K050750 | LC BRACKET ADHESIVE SYSTEM | Dentsply Intl. | 2005-04-06 | 14 | 0 |
| K042422 | D3 CHROMA | Sybron Dental Specialties, Inc. | 2004-11-15 | 69 | 0 |
| K040375 | IDEAL 1 ORTHODONTIC BAND CEMENT | Dentsply Intl. | 2004-04-02 | 45 | 0 |
| K040548 | AEGIS ORTHO LIGHT-CURED ORTHODONTIC ADHESIVE | Harry J. Bosworth Co. | 2004-03-19 | 17 | 0 |
| K040547 | AEGIS ORTHO DUAL-CURED ORTHODONTIC ADHESIVE | Harry J. Bosworth Co. | 2004-03-19 | 17 | 0 |
| K033703 | IDEAL 1 ORTHODONTIC BRACKET ADHESIVE | Dentsply Intl. | 2004-02-06 | 73 | 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