510(k) K831037
K831037 is an FDA 510(k) premarket notification submitted by Taco Dental, Inc. for the device "AIR BURBINE HANDPIECE-DENTAL SCALING". The FDA issued a decision of Substantially Equivalent on May 9, 1983. The device falls under product code ELB (Scaler, Rotary), a Class II device regulated under 21 CFR 872.4840.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 9, 1983
- Date Received
- March 31, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Scaler, Rotary
- Device Class
- Class II
- Regulation Number
- 872.4840
- Review Panel
- DE
- Submission Type