DYJ — Retainer, Screw Expansion, Orthodontic Class I
FDA product code DYJ covers "Retainer, Screw Expansion, Orthodontic", a Class I medical device regulated under 21 CFR 872.5410. Submissions are reviewed by the Dental panel. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DYJ
- Device Class
- Class I
- Regulation Number
- 872.5410
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K970930 | cleft palate appliances | BILATERAL INFANT CLEFT PALATE ORTHODONTIC APPLIANCE | April 23, 1997 |
| K935154 | dentauraum | DENTAURUM EXPANSION SCREWS | February 3, 1994 |
| K925088 | forestadent | EXPANSION SCREWS | May 22, 1993 |
| K912417 | american orthodontics | MOLAR DISTALIZING ASSEMBLY | December 20, 1991 |
| K843705 | a company | MANDIBULATOR JAW POSITIONER | November 14, 1984 |