510(k) K053178
K053178 is an FDA 510(k) premarket notification submitted by Hu-Friedy Mfg. Co., Inc. for the device "SYMMETRY S-SERIES PIEZOELECTRIC SCALING TIPS". The FDA issued a decision of Substantially Equivalent on February 1, 2006. The device falls under product code ELC (Scaler, Ultrasonic), a Class II device regulated under 21 CFR 872.4850. Hu-Friedy Mfg. Co., Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 1, 2006
- Date Received
- November 14, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Scaler, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 872.4850
- Review Panel
- DE
- Submission Type