510(k) K111078
K111078 is an FDA 510(k) premarket notification submitted by Aseptico, Inc. for the device "AEU-26L ELCTRONIC ENDODONTIC SYSTEM". The FDA issued a decision of Substantially Equivalent on June 14, 2011. The device falls under product code EKX (Handpiece, Direct Drive, Ac-Powered), a Class I device regulated under 21 CFR 872.4200. Aseptico, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 14, 2011
- Date Received
- April 18, 2011
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Handpiece, Direct Drive, Ac-Powered
- Device Class
- Class I
- Regulation Number
- 872.4200
- Review Panel
- DE
- Submission Type