Cleared Traditional

K863834 - EVIDENT MARK 2 APEX LOCATOR

K863834 · Pulpdent Corp. of America · Dental device
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Feb 1987
Decision
129d
Days
-
Risk

K863834 is an FDA 510(k) clearance for the EVIDENT MARK 2 APEX LOCATOR.

Submitted by Pulpdent Corp. of America (Brookline, US). The FDA issued a Cleared decision on February 6, 1987 after a review of 129 days - within the typical 510(k) review window.

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.

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FDA 510(k) Submission Details - K863834

510(k) Number K863834 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1986
Decision Date February 06, 1987
Days to Decision 129 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 127d · This submission: 129d
Pathway characteristics
Predicate-based equivalence.

Device Classification - Class ,

Product Code -
Device Class -