MOLAR DISTALIZING ASSEMBLY
FDA 510(k) clearance K912417 · decided 1991-12-20
Clearance details
- K-number
- K912417
- Device name
- MOLAR DISTALIZING ASSEMBLY
- Applicant
- American Orthodontics
- Decision
- Substantially Equivalent
- Date received
- 1991-05-31
- Decision date
- 1991-12-20
- Days to decision
- 203 days
- Clearance type
- Traditional
- Product code
- DYJ
- Device class
- 1
- Regulation number
- 872.5410
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Sheboygan, WI, 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 |
|---|---|---|
| BILATERAL INFANT CLEFT PALATE ORTHODONTIC APPLIANCE (K970930) | Cleft Palate Appliances, Inc. | 1997-04-23 |
| DENTAURUM EXPANSION SCREWS (K935154) | Dentauraum, Inc. | 1994-02-03 |
| EXPANSION SCREWS (K925088) | Forestadent | 1993-05-22 |
| MANDIBULATOR JAW POSITIONER (K843705) | A Company, Inc. | 1984-11-14 |
Recalls involving this device
No recalls on record reference this clearance.