Cleared Traditional

K863011 - DENTATUS LS/EUROFLEX F-IV/ISOLIGHT REFLECT/CM-II
(FDA 510(k) Clearance)

K863011 · Sds Dental, Inc. · Dental device
Oct 1986
Decision
63d
Days
—
Risk

K863011 is an FDA 510(k) clearance for the DENTATUS LS/EUROFLEX F-IV/ISOLIGHT REFLECT/CM-II..

Submitted by Sds Dental, Inc. (Washington, US). The FDA issued a Cleared decision on October 10, 1986, 63 days after receiving the submission on August 8, 1986.

This device falls under the Dental FDA review panel.

Submission Details

510(k) Number K863011 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1986
Decision Date October 10, 1986
Days to Decision 63 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code —
Device Class —