510(k) K132356
K132356 is an FDA 510(k) premarket notification submitted by Scican GmbH for the device "SANAO 200L, SANAO 40 /SANAO 40L, SANAO 10L, SANAO PSI / SANAO PSO, SANAO 40ST". The FDA issued a decision of Substantially Equivalent on January 31, 2014. The device falls under product code EGS (Handpiece, Contra- And Right-Angle Attachment, Dental), a Class I device regulated under 21 CFR 872.4200. Scican GmbH has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 31, 2014
- Date Received
- July 29, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Handpiece, Contra- And Right-Angle Attachment, Dental
- Device Class
- Class I
- Regulation Number
- 872.4200
- Review Panel
- DE
- Submission Type