510(k) K061042
K061042 is an FDA 510(k) premarket notification submitted by Sybron Dental Specialties for the device "LINGLOCK". The FDA issued a decision of Substantially Equivalent on January 19, 2007. The device falls under product code DYW (Bracket, Plastic, Orthodontic), a Class II device regulated under 21 CFR 872.5470. Sybron Dental Specialties has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 19, 2007
- Date Received
- April 14, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bracket, Plastic, Orthodontic
- Device Class
- Class II
- Regulation Number
- 872.5470
- Review Panel
- DE
- Submission Type