510(k) K925712
K925712 is an FDA 510(k) premarket notification submitted by Reliance Orthodontic Products, Inc. for the device "RELIANCE SHORT STICK TIE". The FDA issued a decision of Substantially Equivalent on January 11, 1993. The device falls under product code DYX (Lock, Wire, And Ligature, Intraoral), a Class II device regulated under 21 CFR 872.4600. Reliance Orthodontic Products, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 11, 1993
- Date Received
- November 12, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lock, Wire, And Ligature, Intraoral
- Device Class
- Class II
- Regulation Number
- 872.4600
- Review Panel
- DE
- Submission Type