Cleared Traditional

SAPPHIRE PLUS SCALER MOD. 300114/PLUGGER MOD. 300115/CUTTING MOD. 300116/SPREADER MOD. 300117 TIPS

K960889 · San Diego Swiss Machining, Inc. · Dental

May 1996

Decision

67d

Days

Class 2

Risk

About This 510(k) Submission

K960889 is an FDA 510(k) clearance for the SAPPHIRE PLUS SCALER MOD. 300114/PLUGGER MOD. 300115/CUTTING MOD. 300116/SPREADER MOD. 300117 TIPS, a Scaler, Ultrasonic (Class II — Special Controls, product code ELC), submitted by San Diego Swiss Machining, Inc. (San Diego, US). The FDA issued a Cleared decision on May 10, 1996, 67 days after receiving the submission on March 4, 1996. This device falls under the Dental review panel. Regulated under 21 CFR 872.4850.

Submission Details

510(k) Number	K960889 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 04, 1996
Decision Date	May 10, 1996
Days to Decision	67 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF