Cleared Traditional

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

K863011 · Sds Dental, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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 after a review of 63 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sds Dental, Inc. devices

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 -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 127d · This submission: 63d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -