Cleared Traditional

EVIDENT MARK 2 APEX LOCATOR (K863834) - FDA 510(k) Clearance

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.

View all Pulpdent Corp. of America devices

Submission Details

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

Product Code -
Device Class -