Cleared Traditional

K900731 - MEDI LISS DENTAL ANALGESIA DEVICE (SBL601)

K900731 · Medical Consultants Intl. , Ltd. · Dental device
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Dec 1990
Decision
305d
Days
-
Risk

K900731 is an FDA 510(k) clearance for the MEDI LISS DENTAL ANALGESIA DEVICE (SBL601). Classified as Device, Electrical Dental Anesthesia (product code LWM).

Submitted by Medical Consultants Intl. , Ltd. (Glen Rock, US). The FDA issued a Cleared decision on December 17, 1990 after a review of 305 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: 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.

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FDA 510(k) Submission Details - K900731

510(k) Number K900731 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 1990
Decision Date December 17, 1990
Days to Decision 305 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
178d slower than avg
Panel avg: 127d · This submission: 305d
Pathway characteristics
Predicate-based equivalence.

LWM Device Classification - Class 0,

Product Code LWM Device, Electrical Dental Anesthesia
Device Class -