Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Great Lakes Orthodontics, Ltd. · Predicate Candidate Screening
13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
74 daysmedian FDA review time
372 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K172765 | Smart Moves Complete | Great Lakes Orthodontics, Ltd. | 2018-06-01 | 261 | 0 |
| K150702 | Exceed Tx | Great Lakes Orthodontics, Ltd. | 2016-03-24 | 372 | 0 |
| K083479 | BIOCRYL X | Great Lakes Orthodontics, Ltd. | 2009-02-27 | 95 | 0 |
| K041718 | KELES FACEMASK | Great Lakes Orthodontics, Ltd. | 2004-10-15 | 113 | 0 |
| K040881 | METACRYL | Great Lakes Orthodontics, Ltd. | 2004-05-25 | 50 | 0 |
| K033632 | VARIFLEX | Great Lakes Orthodontics, Ltd. | 2004-01-21 | 63 | 0 |
| K922818 | SNORE-NO-MORE | Great Lakes Orthodontics, Ltd. | 1994-02-09 | 608 | 0 |
| K925275 | SOFT DENTURE RELINE MATERIAL ELASTOLINE | Great Lakes Orthodontics, Ltd. | 1993-01-11 | 83 | 0 |
| K870908 | STEADY RESIN | Great Lakes Orthodontics, Ltd. | 1987-03-19 | 14 | 0 |
| K861424 | ADAPTABLE CLASS III MASK | Great Lakes Orthodontics, Ltd. | 1986-05-29 | 43 | 0 |
| K840805 | ORAL SAFE | Great Lakes Orthodontics, Ltd. | 1984-03-30 | 35 | 0 |
| K832425 | GREAT LAKES PASTE SOLDER | Great Lakes Orthodontics, Ltd. | 1983-10-04 | 74 | 0 |
| K832359 | ORAL SAFE | Great Lakes Orthodontics, Ltd. | 1983-09-26 | 70 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda