510(k) K010195
K010195 is an FDA 510(k) premarket notification submitted by Premier Dental Products Co. for the device "PREMIER ULTRASONIC SCALER AND INSERTS". The FDA issued a decision of Substantially Equivalent on April 17, 2001. The device falls under product code ELC (Scaler, Ultrasonic), a Class II device regulated under 21 CFR 872.4850. Premier Dental Products Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 17, 2001
- Date Received
- January 22, 2001
- 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