510(k) K994299
K994299 is an FDA 510(k) premarket notification submitted by Bonart Co., Ltd. for the device "ART-P3, MODEL P3-1-ART-A1". The FDA issued a decision of Substantially Equivalent on March 6, 2000. The device falls under product code ELC (Scaler, Ultrasonic), a Class II device regulated under 21 CFR 872.4850. Bonart Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 6, 2000
- Date Received
- December 21, 1999
- 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