510(k) K113301
K113301 is an FDA 510(k) premarket notification submitted by Dentalez, Inc. for the device "CONCENPIECE,HIGH-SPEED HANDPIECE SERIES". The FDA issued a decision of Substantially Equivalent on January 23, 2012. The device falls under product code EFB (Handpiece, Air-Powered, Dental), a Class I device regulated under 21 CFR 872.4200. Dentalez, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 23, 2012
- Date Received
- November 8, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Handpiece, Air-Powered, Dental
- Device Class
- Class I
- Regulation Number
- 872.4200
- Review Panel
- DE
- Submission Type