Great Lakes Orthodontics, Ltd.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 13
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K172765 | Smart Moves Complete | June 1, 2018 |
| K150702 | Exceed Tx | March 24, 2016 |
| K083479 | BIOCRYL X | February 27, 2009 |
| K041718 | KELES FACEMASK | October 15, 2004 |
| K040881 | METACRYL | May 25, 2004 |
| K033632 | VARIFLEX | January 21, 2004 |
| K922818 | SNORE-NO-MORE | February 9, 1994 |
| K925275 | SOFT DENTURE RELINE MATERIAL ELASTOLINE | January 11, 1993 |
| K870908 | STEADY RESIN | March 19, 1987 |
| K861424 | ADAPTABLE CLASS III MASK | May 29, 1986 |
| K840805 | ORAL SAFE | March 30, 1984 |
| K832425 | GREAT LAKES PASTE SOLDER | October 4, 1983 |
| K832359 | ORAL SAFE | September 26, 1983 |