Rocky Mountain Orthodontics, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Rocky Mountain Orthodontics, Inc.” (first 1978, latest 1989), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 34 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 | 2 | 2 |
| DZD | Tube, Orthodontic | 1 | 1 |
| EBF | Material, Tooth Shade, Resin | 1 | 1 |
| EHY | Tray, Impression, Preformed | 1 | 1 |
| EJF | Bracket, Metal, Orthodontic | 1 | 1 |
Review panels
- Dental (6)
Most recent Rocky Mountain Orthodontics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K895401 | NORTHERNLIGHTS ORTHODONTIC BONDING SYSTEM | EBF | 1989-12-04 | 88 |
| K843527 | ORTHOMITE 111 ADHESIVE | DYH | 1984-10-18 | 41 |
| K780678 | IMPRESSION TRAY | EHY | 1978-04-28 | 4 |
| K780334 | ADHESIVE, BRACKET AND CONDITIONER RESIN | DYH | 1978-03-28 | 28 |
| K780170 | ORTHODONTIC BRACKET PADS | EJF | 1978-03-15 | 41 |
| K780205 | ORTHODONTIC BUCCAL TUBE | DZD | 1978-02-16 | 9 |
Recalls
openFDA lists no recalls under a recalling firm named Rocky Mountain 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.
- Rocky Mountain Medical Corp. (9 510(k)s)
- Rocky Mountain Research, Inc. (5 510(k)s)
- Rocky Mountain Biosystems, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Rocky Mountain Orthodontics, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Rocky Mountain Orthodontics, Inc.” (first 1978, latest 1989), across 5 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 Rocky Mountain Orthodontics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Rocky Mountain Orthodontics, Inc. is 34 days.
Which FDA product codes appear under Rocky Mountain Orthodontics, Inc.?
The most frequent FDA product codes under this applicant name are DYH (Adhesive, Bracket And Tooth Conditioner, Resin, 2); DZD (Tube, Orthodontic, 1); EBF (Material, Tooth Shade, Resin, 1).
Next steps
- See all 6 Rocky Mountain Orthodontics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DYH, Rocky Mountain 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.