Not currently registered with FDA under this name
Rocky Mountain Orthodontics, Inc.
Denver, CO, United States. Named as applicant on 6 dental 510(k) clearances between 1978 and 1989. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 61978–1989
- Markets registered in
- 669 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1976–2026
Registered in 6 markets
Where regulators' registries name Rocky Mountain Orthodontics, Inc. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | Rocky Mountain Orthodontics, Inc. | 6 clearances | 1978–1989 | Below |
| South Korea | MFDS | Manufacturer | Rocky Mountain Orthodontics INC.Rocky Mountain Orthodontics Inc. · ROCKY MOUNTAIN ORTHODONTICS, INC · +2 | 30 | 1998–2014 | Pure Global AI |
| Colombia | INVIMA | Registration holder | ROCKY MOUNTAIN ORTHODONTICS, INC | 12 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | ROCKY MOUNTAIN ORTHODONTICS INC | 11 | 2005–2020 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | ROCKY MOUNTAIN ORTHODONTICS | 8 | 2014–2025 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | ROCKY MOUNTAIN ORTHODONTICSROCKY MOUNTAIN ORTHODONTICS, INC. | 8 | 2006–2019 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
510(k) clearances
Clearances on which FDA names Rocky Mountain Orthodontics, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 4 Dec 1989 | K895401 | NORTHERNLIGHTS ORTHODONTIC BONDING SYSTEM | EBF Resin Tooth Shade Material |
| 18 Oct 1984 | K843527 | ORTHOMITE 111 ADHESIVE | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 28 Apr 1978 | K780678 | IMPRESSION TRAY | EHY Preformed Impression Tray |
| 28 Mar 1978 | K780334 | ADHESIVE, BRACKET AND CONDITIONER RESIN | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 15 Mar 1978 | K780170 | ORTHODONTIC BRACKET PADS | EJF Orthodontic Metal Bracket |
| 16 Feb 1978 | K780205 | ORTHODONTIC BUCCAL TUBE | DZD Orthodontic Tube |
Sources
FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.