Cleared Traditional

K935616 - SALIVA EJECTOR DISPOSABLE
(FDA 510(k) Clearance)

K935616 · Asa Instruments S.R.L. · Dental device

Mar 1994

Decision

119d

Days

Class 1

Risk

K935616 is an FDA 510(k) clearance for the SALIVA EJECTOR DISPOSABLE. This device is classified as a Mouthpiece, Saliva Ejector (Class I - General Controls, product code DYN).

Submitted by Asa Instruments S.R.L. (Massarosa (Lucca) Italy, IT). The FDA issued a Cleared decision on March 21, 1994, 119 days after receiving the submission on November 22, 1993.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6640.

Submission Details

510(k) Number	K935616 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 22, 1993
Decision Date	March 21, 1994
Days to Decision	119 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement