510(k) K132356

SANAO 200L, SANAO 40 /SANAO 40L, SANAO 10L, SANAO PSI / SANAO PSO, SANAO 40ST by Scican GmbH — Product Code EGS

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