Midwest Orthodontic Mfg.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Midwest Orthodontic Mfg.” (first 1990, latest 1998), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 75 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | 4 | 4 |
| DYW | Bracket, Plastic, Orthodontic | 1 | 1 |
| EJF | Bracket, Metal, Orthodontic | 1 | 1 |
| KLE | Agent, Tooth Bonding, Resin | 1 | 1 |
Review panels
- Dental (7)
Most recent Midwest Orthodontic Mfg. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K981433 | ORTHODONTIC BRACES | DYW | 1998-06-25 | 66 |
| K955740 | GLUFLORMA | KLE | 1996-02-08 | 55 |
| K952856 | LIGHT-CURE PC | DYH | 1995-09-12 | 82 |
| K952855 | PC-LOCK | DYH | 1995-09-08 | 78 |
| K952858 | LIGHT-CURE | DYH | 1995-09-05 | 75 |
| K952857 | PRO-LOCK | DYH | 1995-09-05 | 75 |
| K900824 | FLUOR-I-CHAINS(TM) AND FLUOR-I-TIES(TM) | EJF | 1990-05-22 | 90 |
Recalls
openFDA lists no recalls under a recalling firm named Midwest Orthodontic Mfg..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Midwest (13 510(k)s)
- Midwest City Hearing Aid Center (12 510(k)s)
- Midwest Rf, LLC (9 510(k)s)
- Midwest Dental Products Corp. (5 510(k)s)
- Midwest Metabolic Support Group (4 510(k)s)
- Midwest Reprocessing Center, LLC (4 510(k)s)
- Midwest Analog & Digital, Inc. (3 510(k)s)
- Midwest Implant Sales, Inc. (3 510(k)s)
- Midwest X-Ray Equipment Co. (3 510(k)s)
- Midwest Eye Laboratories, Inc. (2 510(k)s)
- Midwest Development (1 510(k)s)
- Midwest Marketing Service (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Midwest Orthodontic Mfg.?
FDA lists 7 510(k) clearances under the applicant name “Midwest Orthodontic Mfg.” (first 1990, latest 1998), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Midwest Orthodontic Mfg.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Midwest Orthodontic Mfg. is 75 days.
Which FDA product codes appear under Midwest Orthodontic Mfg.?
The most frequent FDA product codes under this applicant name are DYH (Adhesive, Bracket And Tooth Conditioner, Resin, 4); DYW (Bracket, Plastic, Orthodontic, 1); EJF (Bracket, Metal, Orthodontic, 1).
Next steps
- See all 7 Midwest Orthodontic Mfg. clearances with predicates and recalls
- Run predicate analysis for product code DYH, Midwest Orthodontic Mfg.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.