Cleared Traditional

PACIFIC IMPLANT TITANIUM ENDODONTIC POINT (K992582) - FDA 510(k) Clearance

Class I Dental device.

K992582 · Pacific Implant, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1999
Decision
80d
Days
Class 1
Risk

K992582 is an FDA 510(k) clearance for the PACIFIC IMPLANT TITANIUM ENDODONTIC POINT. Classified as Point, Silver, Endodontic (product code EKL), Class I - General Controls.

Submitted by Pacific Implant, Inc. (Washington, US). The FDA issued a Cleared decision on October 21, 1999 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3840 - 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 Pacific Implant, Inc. devices

Submission Details

510(k) Number K992582 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 1999
Decision Date October 21, 1999
Days to Decision 80 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 127d · This submission: 80d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EKL Point, Silver, Endodontic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3840
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.