Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dmg USA, Inc. — Predicate Candidate Screening
28 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
79 daysmedian FDA review time
226 days90th percentile
28clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K171772 | Ecosite Bulk Fill | Dmg USA, Inc. | 2018-01-31 | 231 | 0 |
| K160443 | TempoCem Clear | Dmg USA, Inc. | 2016-09-30 | 226 | 0 |
| K130580 | RETRACTION PASTE | Dmg USA, Inc. | 2014-02-25 | 357 | 0 |
| K110759 | TEMPOCEM | Dmg USA, Inc. | 2011-06-10 | 84 | 0 |
| K102603 | SA FLOWABLE ADHESIVE | Dmg USA, Inc. | 2010-11-17 | 68 | 0 |
| K101710 | LUXATEMP ULTRA /STAR | Dmg USA, Inc. | 2010-09-28 | 103 | 0 |
| K100062 | INFILTRATION KIT | Dmg USA, Inc. | 2010-03-26 | 74 | 0 |
| K093338 | SELF ADHESIVE COMPOSITE LUTING CEMENT | Dmg USA, Inc. | 2010-02-12 | 112 | 0 |
| K093587 | DENTAL MERCURY | Dmg USA, Inc. | 2010-01-21 | 63 | 0 |
| K081493 | INFILTRATION KIT | Dmg USA, Inc. | 2008-09-18 | 113 | 0 |
| K080480 | NANOCOMPOSITE RESTORATIVE KIT | Dmg USA, Inc. | 2008-05-30 | 98 | 0 |
| K080479 | DENTAL CERAMIC | Dmg USA, Inc. | 2008-05-21 | 89 | 0 |
| K063444 | TOTAL ETCH BONDING AGENT | Dmg USA, Inc. | 2007-03-20 | 125 | 0 |
| K052800 | PROVISIONAL INLAY/ONLAY KIT | Dmg USA, Inc. | 2006-03-07 | 155 | 0 |
| K041960 | COMPOSITE/COMPOMER REPAIR KIT | Dmg USA, Inc. | 2004-08-30 | 40 | 0 |
| K033227 | LUXAFORM PLUS | Dmg USA, Inc. | 2004-01-16 | 102 | 0 |
| K023649 | VITIQUE SYSTEM | Dmg USA, Inc. | 2003-01-17 | 79 | 0 |
| K013674 | LUXATEMP/LUXATEMP SOLAR/INSTATEMP | Dmg USA, Inc. | 2002-01-24 | 78 | 0 |
| K013571 | MAGICFIL | Dmg USA, Inc. | 2002-01-17 | 80 | 0 |
| K013237 | STATUSBLUE | Dmg USA, Inc. | 2001-10-22 | 24 | 0 |
| K013236 | LUXABITE | Dmg USA, Inc. | 2001-10-17 | 19 | 0 |
| K013179 | LUXAGLAZE | Dmg USA, Inc. | 2001-10-12 | 18 | 0 |
| K012307 | LUXACORE/LUXACORE DUAL | Dmg USA, Inc. | 2001-08-23 | 31 | 0 |
| K012316 | PERMACEM / PERMACEM DUAL | Dmg USA, Inc. | 2001-08-23 | 31 | 0 |
| K011211 | FLOWABLE COMPOSITE/ ECUFLOW/ LUXAFLOW | Dmg USA, Inc. | 2001-06-18 | 60 | 0 |
| K002086 | PRIMAFLOW | Dmg USA, Inc. | 2000-08-17 | 38 | 0 |
| K000878 | HONIGUM | Dmg USA, Inc. | 2000-04-11 | 22 | 0 |
| K000951 | LUXAFORM | Dmg USA, Inc. | 2000-04-05 | 13 | 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