Cleared Traditional

ULTRACALM (K910625) - FDA 510(k) Clearance

K910625 · Sion Technology, Inc. · Dental device
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May 1992
Decision
458d
Days
-
Risk

K910625 is an FDA 510(k) clearance for the ULTRACALM. Classified as Device, Electrical Dental Anesthesia (product code LWM).

Submitted by Sion Technology, Inc. (Aurora, US). The FDA issued a Cleared decision on May 15, 1992 after a review of 458 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Sion Technology, Inc. devices

Submission Details

510(k) Number K910625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1991
Decision Date May 15, 1992
Days to Decision 458 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
331d slower than avg
Panel avg: 127d · This submission: 458d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LWM Device, Electrical Dental Anesthesia
Device Class -