ECOClass I
Spring, Orthodontic
21 CFR 872.5410 / Dental
ECO is the FDA product code for Spring, Orthodontic, a class I device type, regulated under 21 CFR 872.5410. As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and 13 recalls.
Classification record
- Product code
- ECO
- Device name
- Spring, Orthodontic
- Regulation
- 21 CFR 872.5410
- Device class
- Class I
- Review panel
- Dental
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 7
- Ingested recalls
- 13
Clearances, product code ECO
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1984 | 2 |
| 1985 | 1 |
| 1994 | 3 |
Applicants with the most clearances
Product code ECO| Applicant | Clearances |
|---|---|
| Active Vertical Correctors, Inc. | 2 |
| Gac Intl., Inc. | 1 |
| Hmw Industries | 1 |
| Medical Magnetics, Inc. | 1 |
| Ormco Corp. | 1 |
| Orthoplus, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- Acme-Monaco Corp.
- Aditek do Brasil, SA
- Alta Smiles, LLC
- American Orthodontics
- Astar Orthodontics Inc.
- Beijing Smart Technology Co., Ltd.
- Biomaterials Korea Inc.
- Changsha Nice Medical Instrument Limited Company
- Csy International LLC
- D B Orthodontics Ltd
- Debo Medical Technology (Shijiazhuang) Co., Ltd.
- Dental Morelli Ltda.
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
