Northwest Orthodontics, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Northwest Orthodontics, Inc.” (first 1977, latest 1980), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 14 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 |
|---|---|---|---|
| DZB | Headgear, Extraoral, Orthodontic | 5 | 5 |
| DYT | Maintainer, Space Preformed, Orthodontic | 1 | 1 |
Review panels
- Dental (6)
Most recent Northwest Orthodontics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K800748 | SNAP-WAY HEADGEAR | DZB | 1980-04-10 | 6 |
| K790843 | SNAP-WAY | DZB | 1979-05-31 | 29 |
| K780814 | SAFETY STOP NECKSTRAP | DYT | 1978-06-30 | 43 |
| K780747 | SNAP-WAY | DZB | 1978-05-26 | 18 |
| K771706 | SAIF-BOW | DZB | 1977-09-20 | 11 |
| K771095 | J HOOK HEADGEAR | DZB | 1977-06-24 | 4 |
Recalls
openFDA lists no recalls under a recalling firm named Northwest Orthodontics, Inc..
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.
- Northwest Medical Physics Center (6 510(k)s)
- Northwest Medical Physics Equipment, Inc. (6 510(k)s)
- Northwest Biotech (2 510(k)s)
- Northwest Surgical Concepts, Inc. (2 510(k)s)
- Northwest Alabama Urological Assoc. (1 510(k)s)
- Northwest Orthopedics (1 510(k)s)
- Northwest Precision Technologies (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Northwest Orthodontics, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Northwest Orthodontics, Inc.” (first 1977, latest 1980), across 2 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 Northwest Orthodontics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Northwest Orthodontics, Inc. is 14 days.
Which FDA product codes appear under Northwest Orthodontics, Inc.?
The most frequent FDA product codes under this applicant name are DZB (Headgear, Extraoral, Orthodontic, 5); DYT (Maintainer, Space Preformed, Orthodontic, 1).
Next steps
- See all 6 Northwest Orthodontics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DZB, Northwest Orthodontics, Inc.'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.