510(k) K912417
K912417 is an FDA 510(k) premarket notification submitted by American Orthodontics for the device "MOLAR DISTALIZING ASSEMBLY". The FDA issued a decision of Substantially Equivalent on December 20, 1991. The device falls under product code DYJ (Retainer, Screw Expansion, Orthodontic), a Class I device regulated under 21 CFR 872.5410. American Orthodontics has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 20, 1991
- Date Received
- May 31, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Retainer, Screw Expansion, Orthodontic
- Device Class
- Class I
- Regulation Number
- 872.5410
- Review Panel
- DE
- Submission Type