SANAO 200L, SANAO 40 /SANAO 40L, SANAO 10L, SANAO PSI / SANAO PSO, SANAO 40ST

Handpiece, Contra- And Right-angle Attachment, Dental

SCICAN GMBH

The following data is part of a premarket notification filed by Scican Gmbh with the FDA for Sanao 200l, Sanao 40 /sanao 40l, Sanao 10l, Sanao Psi / Sanao Pso, Sanao 40st.

Pre-market Notification Details

• Device ID: K132356
• 510k Number: K132356
• Device Name: SANAO 200L, SANAO 40 /SANAO 40L, SANAO 10L, SANAO PSI / SANAO PSO, SANAO 40ST
• Classification: Handpiece, Contra- And Right-angle Attachment, Dental
• Applicant: SCICAN GMBH WANGENER STR. 78 Leutkirch, DE 88299
• Contact: Josef Sillet
• Product Code: EGS
• CFR Regulation Number: 872.4200 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2013-07-29
• Decision Date: 2014-01-31
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
D7022654750	K132356	000
D7022654740	K132356	000
D7022654730	K132356	000
D7022654720	K132356	000
D7022654710	K132356	000
00366975013040	K132356	000