MESIAL LOOP BAR
FDA 510(k) clearance K933542 · decided 1994-08-05
Clearance details
- K-number
- K933542
- Device name
- MESIAL LOOP BAR
- Applicant
- Gac Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-07-20
- Decision date
- 1994-08-05
- Days to decision
- 381 days
- Clearance type
- Traditional
- Product code
- ECO
- Device class
- 1
- Regulation number
- 872.5410
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Central Islip, NY, US
- Third-party review
- No
- Expedited review
- No
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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 |
| ADJUSTABLE BITE CORRECTOR (K942492) | Orthoplus, Inc. | 1994-07-13 |
| 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.