Cleared Traditional

BIOSONICS SALIVARY TESTER (K833635) - FDA 510(k) Clearance

K833635 · Meyer, Faller & Weisman · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1984
Decision
133d
Days
-
Risk

K833635 is an FDA 510(k) clearance for the BIOSONICS SALIVARY TESTER.

Submitted by Meyer, Faller & Weisman (Mchenry, US). The FDA issued a Cleared decision on February 27, 1984 after a review of 133 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Meyer, Faller & Weisman devices

Submission Details

510(k) Number K833635 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 1983
Decision Date February 27, 1984
Days to Decision 133 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 127d · This submission: 133d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -