Cleared Traditional

K863393 - ENDOCATER

K863393 · The Hygenic Corp. · Dental device
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Jun 1987
Decision
281d
Days
-
Risk

K863393 is an FDA 510(k) clearance for the ENDOCATER. Classified as Locator, Root Apex (product code LQY).

Submitted by The Hygenic Corp. (Akron, US). The FDA issued a Cleared decision on June 11, 1987 after a review of 281 days - an extended review cycle.

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 The Hygenic Corp. devices

FDA 510(k) Submission Details - K863393

510(k) Number K863393 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1986
Decision Date June 11, 1987
Days to Decision 281 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
154d slower than avg
Panel avg: 127d · This submission: 281d
Pathway characteristics
Predicate-based equivalence.

LQY Device Classification - Class 0,

Product Code LQY Locator, Root Apex
Device Class -