Great Lakes Orthodontics, Ltd.
Tonawanda, NY, US
Great Lakes Orthodontics, Ltd. appears in FDA device records in Tonawanda, NY. FDA records list 13 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 13
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 13 510(k) clearances for Great Lakes Orthodontics, Ltd. between 1983 and 2018. The busiest year on record is 2004, with 3. The most recent is 2018, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1983 | 2 |
| 1984 | 1 |
| 1986 | 1 |
| 1987 | 1 |
| 1993 | 1 |
| 1994 | 1 |
| 2004 | 3 |
| 2009 | 1 |
| 2016 | 1 |
| 2018 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K172765 | Smart Moves Complete | NXC | Substantially Equivalent | |
| K150702 | Exceed Tx | DYW | Substantially Equivalent | |
| K083479 | BIOCRYL X | EBI | Substantially Equivalent | |
| K041718 | KELES FACEMASK | DZB | Substantially Equivalent | |
| K040881 | METACRYL | EBI | Substantially Equivalent | |
| K033632 | VARIFLEX | EBI | Substantially Equivalent | |
| K922818 | SNORE-NO-MORE | LQZ | Substantially Equivalent | |
| K925275 | SOFT DENTURE RELINE MATERIAL ELASTOLINE | EBI | Substantially Equivalent | |
| K870908 | STEADY RESIN | EBI | Substantially Equivalent | |
| K861424 | ADAPTABLE CLASS III MASK | DZB | Substantially Equivalent | |
| K840805 | ORAL SAFE | JER | Substantially Equivalent | |
| K832425 | GREAT LAKES PASTE SOLDER | EJS | Substantially Equivalent | |
| K832359 | ORAL SAFE | JER | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain