Spring, Orthodontic
The Orthodontic Spring is a metal component incorporated into fixed or removable orthodontic appliances to apply controlled, directional forces that tip, torque, or move individual teeth to their desired positions. It is classified as FDA Class 1, the lowest risk category, subject only to general controls and no premarket submission is required. The product code is ECO and the applicable regulation is 21 CFR 872.5410, under the Dental medical specialty.
Basic Information
- Product Code
- ECO
- Device Class
- FDA class 1
- Regulation Number
- 872.5410
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K943068 | MAGNEFORCE | Aug 17, 1994 | Substantially Equivalent | ORMCO CORP. |
| K933542 | MESIAL LOOP BAR | Aug 05, 1994 | Substantially Equivalent | GAC INTL., INC. |
| K942492 | ADJUSTABLE BITE CORRECTOR | Jul 13, 1994 | Substantially Equivalent | ORTHOPLUS, INC. |
| K844234 | ACTIVE VERTICAL CORRECTOR APPLIANCE | Jan 04, 1985 | Substantially Equivalent | ACTIVE VERTICAL CORRECTORS, INC. |
| K843550 | ORTHOMAG MAGNETIC FORCE SYSTEM | Dec 21, 1984 | Substantially Equivalent | MEDICAL MAGNETICS, INC. |
| K843344 | ACTIVE VERTICAL CORRECTOR ACTIVE BITE | Dec 03, 1984 | Substantially Equivalent | ACTIVE VERTICAL CORRECTORS, INC. |
| K770558 | ISODYNE | Apr 05, 1977 | Substantially Equivalent | HMW INDUSTRIES |
FEI Numbers
This FDA classification entry is associated with 84 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 84 registration numbers. Click on an entry to view related FDA registrations.