Cleared Traditional

ENDOCATER

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

About This 510(k) Submission

K863393 is an FDA 510(k) clearance for the ENDOCATER, a Locator, Root Apex, submitted by The Hygenic Corp. (Akron, US). The FDA issued a Cleared decision on June 11, 1987, 281 days after receiving the submission on September 3, 1986. This device falls under the Dental review panel.

Submission Details

510(k) Number K863393 FDA.gov
FDA Decision Cleared SESE
Date Received September 03, 1986
Decision Date June 11, 1987
Days to Decision 281 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code LQY — Locator, Root Apex
Device Class —

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