Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Great Lakes Orthodontics with 13 510(k) clearances. The most recent is a 510(k) clearance dated Jun 1, 2018: Smart Moves Complete.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jun 1, 2018 | Smart Moves CompleteK172765 · NXC | 510(k) clearances |
| Mar 24, 2016 | Exceed TxK150702 · DYW | 510(k) clearances |
| Feb 27, 2009 | BIOCRYL XK083479 · EBI | 510(k) clearances |
| Oct 15, 2004 | KELES FACEMASKK041718 · DZB | 510(k) clearances |
| May 25, 2004 | METACRYLK040881 · EBI | 510(k) clearances |
| Jan 21, 2004 | VARIFLEXK033632 · EBI | 510(k) clearances |
| Feb 9, 1994 | SNORE-NO-MOREK922818 · LQZ | 510(k) clearances |
| Jan 11, 1993 | SOFT DENTURE RELINE MATERIAL ELASTOLINEK925275 · EBI | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
