Cleared Traditional

OPUS PACEMAKERS (MODELS 4021, 4033, AND 4034) (K952363) - FDA 510(k) Clearance

Class I Dental device.

K952363 · Ela Medical, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1995
Decision
106d
Days
Class 1
Risk

K952363 is an FDA 510(k) clearance for the OPUS PACEMAKERS (MODELS 4021, 4033, AND 4034). Classified as Instrument, Hand, Calculus Removal (product code ELA), Class I - General Controls.

Submitted by Ela Medical, Inc. (Minnetonka, US). The FDA issued a Cleared decision on August 15, 1995 after a review of 106 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Ela Medical, Inc. devices

Submission Details

510(k) Number K952363 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1995
Decision Date August 15, 1995
Days to Decision 106 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
21d faster than avg
Panel avg: 127d · This submission: 106d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ELA Instrument, Hand, Calculus Removal
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.