510(k) K864922
K864922 is an FDA 510(k) premarket notification submitted by E&D Dental Manufacturing Co. for the device "DENTAL HANDPIECES AND ATTACHMENT". The FDA issued a decision of Substantially Equivalent on February 19, 1987. The device falls under product code EKS (File, Pulp Canal, Endodontic), a Class I device regulated under 21 CFR 872.4565. E&D Dental Manufacturing Co. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 19, 1987
- Date Received
- December 16, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- File, Pulp Canal, Endodontic
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type