Cleared Traditional

K914892 - SALIVA-STIM

K914892 is an FDA 510(k) clearance for SALIVA-STIM, manufactured by Orion Diagnostica, Inc.. The device is a Class 1 Dental device with product code EGD cleared through the Traditional 510(k) pathway after a 307-day FDA review.

K914892 · Orion Diagnostica, Inc. · Dental device
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Sep 1992
Decision
307d
Days
Class 1
Risk

K914892 is an FDA 510(k) clearance for the SALIVA-STIM. Classified as Wax, Dental, Intraoral (product code EGD), Class I - General Controls.

Submitted by Orion Diagnostica, Inc. (02101 Espoo, FI). The FDA issued a Cleared decision on September 2, 1992 after a review of 307 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6890 - the FDA dental device regulatory framework. 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. Elevated predicate reliance profile. 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 Orion Diagnostica, Inc. devices

FDA 510(k) Submission Details - K914892

510(k) Number K914892 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1991
Decision Date September 02, 1992
Days to Decision 307 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
180d slower than avg
Panel avg: 127d · This submission: 307d
Pathway characteristics
Predicate-based equivalence.

EGD Device Classification - Class 1, General Controls

Product Code EGD Wax, Dental, Intraoral
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6890
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.