Cleared Traditional

K864976 - SOLUSET CALCIUM DEMINERALIZING SOLUTION (FDA 510(k) Clearance)

Class I Dental device.

K864976 · Endo Technic Corp. · Dental device
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Feb 1987
Decision
70d
Days
Class 1
Risk

K864976 is an FDA 510(k) clearance for the SOLUSET CALCIUM DEMINERALIZING SOLUTION. Classified as File, Pulp Canal, Endodontic (product code EKS), Class I - General Controls.

Submitted by Endo Technic Corp. (Natick, US). The FDA issued a Cleared decision on February 27, 1987 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4565 - the FDA dental device regulatory framework. 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 Endo Technic Corp. devices

Submission Details

510(k) Number K864976 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1986
Decision Date February 27, 1987
Days to Decision 70 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 127d · This submission: 70d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EKS File, Pulp Canal, Endodontic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4565
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.