Cleared Traditional

DENTATUS-S / L / LS / (GNATUS) (K863018) - FDA 510(k) Clearance

K863018 · Sds Dental, Inc. · Dental device
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Sep 1986
Decision
48d
Days
-
Risk

K863018 is an FDA 510(k) clearance for the DENTATUS-S / L / LS / (GNATUS).

Submitted by Sds Dental, Inc. (Washington, US). The FDA issued a Cleared decision on September 25, 1986 after a review of 48 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 K863018 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1986
Decision Date September 25, 1986
Days to Decision 48 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 127d · This submission: 48d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -