Company ยท US
Great Lakes Orthodontics, Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 1983 to 2018. Name variants (Inc, Corp, punctuation) are merged.
13510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 1, 2018 | K172765 | Smart Moves Complete Great Lakes Orthodontics, Ltd. | NXC |
| Mar 24, 2016 | K150702 | Exceed Tx Great Lakes Orthodontics, Ltd. | DYW |
| Feb 27, 2009 | K083479 | BIOCRYL X Great Lakes Orthodontics, Ltd. | EBI |
| Oct 15, 2004 | K041718 | KELES FACEMASK Great Lakes Orthodontics, Ltd. | DZB |
| May 25, 2004 | K040881 | METACRYL Great Lakes Orthodontics, Ltd. | EBI |
| Jan 21, 2004 | K033632 | VARIFLEX Great Lakes Orthodontics, Ltd. | EBI |
| Feb 9, 1994 | K922818 | SNORE-NO-MORE Great Lakes Orthodontics, Ltd. | LQZ |
| Jan 11, 1993 | K925275 | SOFT DENTURE RELINE MATERIAL ELASTOLINE Great Lakes Orthodontics, Ltd. | EBI |
| Mar 19, 1987 | K870908 | STEADY RESIN Great Lakes Orthodontics, Ltd. | EBI |
| May 29, 1986 | K861424 | ADAPTABLE CLASS III MASK Great Lakes Orthodontics, Ltd. | DZB |
| Mar 30, 1984 | K840805 | ORAL SAFE Great Lakes Orthodontics, Ltd. | JER |
| Oct 4, 1983 | K832425 | GREAT LAKES PASTE SOLDER Great Lakes Orthodontics, Ltd. | EJS |
| Sep 26, 1983 | K832359 | ORAL SAFE Great Lakes Orthodontics, Ltd. | JER |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||