Great Lakes Orthodontics, Ltd.: FDA clearances and approvals
Great Lakes Orthodontics, Ltd. has 13 FDA 510(k) clearances (first 1983, latest 2018), across 7 product codes in 1 review panel. Median 510(k) review time: 74 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 372 |
| 2017 | 0 | — |
| 2018 | 1 | 261 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Great Lakes Orthodontics, Ltd.'s cleared 510(k)s took a median 261 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 128 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 5 | 5 |
| DZB | Headgear, Extraoral, Orthodontic | 2 | 2 |
| JER | Cleaner, Denture, Mechanical | 2 | 2 |
| DYW | Bracket, Plastic, Orthodontic | 1 | 1 |
| EJS | Alloy, Other Noble Metal | 1 | 1 |
| LQZ | Device, Jaw Repositioning | 1 | 1 |
| NXC | Aligner, Sequential | 1 | 1 |
Review panels
- Dental (13)
Most recent Great Lakes Orthodontics, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K172765 | Smart Moves Complete | NXC | 2018-06-01 | 261 |
| K150702 | Exceed Tx | DYW | 2016-03-24 | 372 |
| K083479 | BIOCRYL X | EBI | 2009-02-27 | 95 |
| K041718 | KELES FACEMASK | DZB | 2004-10-15 | 113 |
| K040881 | METACRYL | EBI | 2004-05-25 | 50 |
| K033632 | VARIFLEX | EBI | 2004-01-21 | 63 |
| K922818 | SNORE-NO-MORE | LQZ | 1994-02-09 | 608 |
| K925275 | SOFT DENTURE RELINE MATERIAL ELASTOLINE | EBI | 1993-01-11 | 83 |
| K870908 | STEADY RESIN | EBI | 1987-03-19 | 14 |
| K861424 | ADAPTABLE CLASS III MASK | DZB | 1986-05-29 | 43 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Great Lakes Orthodontics, Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Great Lakes Orthodontics, Ltd. have?
Great Lakes Orthodontics, Ltd. has 13 FDA 510(k) clearances (first 1983, latest 2018), across 7 product codes in 1 review panel.
How long does FDA take to clear Great Lakes Orthodontics, Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Great Lakes Orthodontics, Ltd.'s cleared 510(k)s is 74 days.
What devices does Great Lakes Orthodontics, Ltd. make?
Its most frequent FDA product codes are EBI (Resin, Denture, Relining, Repairing, Rebasing, 5); DZB (Headgear, Extraoral, Orthodontic, 2); JER (Cleaner, Denture, Mechanical, 2).
Has Great Lakes Orthodontics, Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Great Lakes Orthodontics, Ltd. Related entities may recall under other names.
Next steps
- See all 13 Great Lakes Orthodontics, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code EBI, Great Lakes Orthodontics, Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.