510(k) K051776
K051776 is an FDA 510(k) premarket notification submitted by Discus Dental, Inc. for the device "PROTEGE ULTRASONIC INSERT". The FDA issued a decision of Substantially Equivalent on July 13, 2005. The device falls under product code ELC (Scaler, Ultrasonic), a Class II device regulated under 21 CFR 872.4850. Discus Dental, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 13, 2005
- Date Received
- July 1, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Scaler, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 872.4850
- Review Panel
- DE
- Submission Type