Orthodontic Bracket Pads
FDA 510(k) K780170 · Rocky Mountain Orthodontics, Inc.
510(k) numberK780170
Submission
- Device name
- Orthodontic Bracket Pads
- Applicant
- Rocky Mountain Orthodontics, Inc.
Mchenry, IL, US - Received
- February 2, 1978
- Decision date
- March 15, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code EJF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K994357 | Bitem Lock, Models SW006, SW012EJF · Traditional | Thermoelastic Technologies, Inc. | 03/14/2000SE |
| K932825 | Microarch Gold BracketEJF · Traditional | Gac Intl., Inc. | 05/09/1994SE |
| K933501 | AlastikEJF · Traditional | Unitek Corp. | 04/28/1994SE |
| K923372 | Memory WireEJF · Traditional | Althan, Inc. | 04/22/1994SE |
| K933080 | Orthotech Dura-Gold BarcketsEJF · Traditional | Orthotech | 03/23/1994SE |
| K935139 | Fascination Ceramic BracketEJF · Traditional | Dentauraum, Inc. | 02/04/1994SE |
| K936244 | Regency BracketEJF · Traditional | Mid-American Dental Specialties, Inc. | 02/02/1994SE |
| K934881 | ReflectionsEJF · Traditional | Cdb Corp. | 02/01/1994SE |
| K935122 | Dentaurum Metal BracketsEJF · Traditional | Dentauraum, Inc. | 01/31/1994SE |
| K926427 | Lariat Palate ExpanderEJF · Traditional | Easy Access Orthodontics, Inc. | 01/26/1994SE |
More from Easy Access Orthodontics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K895401 | Northernlights Orthodontic Bonding SystemEBF · Traditional | 12/04/1989SE |
| K843527 | Orthomite 111 AdhesiveDYH · Traditional | 10/18/1984SE |
| K780678 | Impression TrayEHY · Traditional | 04/28/1978SE |
| K780334 | Adhesive, Bracket and Conditioner ResinDYH · Traditional | 03/28/1978SE |
| K780205 | Orthodontic Buccal TubeDZD · Traditional | 02/16/1978SE |
Questions and answers
When was Orthodontic Bracket Pads cleared by the FDA?
Orthodontic Bracket Pads (K780170) received a 510(k) decision of Substantially Equivalent on March 15, 1978, 41 days after the submission was received.
What is the product code of K780170?
The FDA product code is EJF – Bracket, Metal, Orthodontic, a Class I (low risk) device regulated under 21 CFR 872.5410.