ADJUSTABLE BITE CORRECTOR
FDA 510(k) clearance K942492 · decided 1994-07-13
Clearance details
- K-number
- K942492
- Device name
- ADJUSTABLE BITE CORRECTOR
- Applicant
- Orthoplus, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-05-25
- Decision date
- 1994-07-13
- Days to decision
- 49 days
- Clearance type
- Traditional
- Product code
- ECO
- Device class
- 1
- Regulation number
- 872.5410
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Santa Rosa, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Orthoplus
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MAGNEFORCE (K943068) | Ormco Corp. | 1994-08-17 |
| MESIAL LOOP BAR (K933542) | Gac Intl., Inc. | 1994-08-05 |
| ACTIVE VERTICAL CORRECTOR APPLIANCE (K844234) | Active Vertical Correctors, Inc. | 1985-01-04 |
| ORTHOMAG MAGNETIC FORCE SYSTEM (K843550) | Medical Magnetics, Inc. | 1984-12-21 |
| ACTIVE VERTICAL CORRECTOR ACTIVE BITE (K843344) | Active Vertical Correctors, Inc. | 1984-12-03 |
| ISODYNE (K770558) | Hmw Industries | 1977-04-05 |
Recalls involving this device
No recalls on record reference this clearance.