Cleared Traditional

ENDOCATER (K863393) - FDA 510(k) Clearance

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

Submission Details

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.

Device Classification

Product Code LQY Locator, Root Apex
Device Class -