510(k) K901488
K901488 is an FDA 510(k) premarket notification submitted by Mti Precision Products for the device "LYNX-SM, SCLAER DENTAL HANDPIECE". The FDA issued a decision of Substantially Equivalent on May 15, 1990. The device falls under product code ELC (Scaler, Ultrasonic), a Class II device regulated under 21 CFR 872.4850. Mti Precision Products has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 15, 1990
- Date Received
- March 29, 1990
- 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