510(k) K142124
K142124 is an FDA 510(k) premarket notification submitted by Aseptico, Inc. for the device "AEU-6000 IMPLANT / ENDODONTIC DENTAL SYSTEM". The FDA issued a decision of Substantially Equivalent on December 31, 2014. 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
- December 31, 2014
- Date Received
- August 4, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Handpiece, Direct Drive, Ac-Powered
- Device Class
- Class I
- Regulation Number
- 872.4200
- Review Panel
- DE
- Submission Type