Cleared Traditional

K952363 - OPUS PACEMAKERS (MODELS 4021, 4033, AND 4034)

K952363 is an FDA 510(k) clearance for OPUS PACEMAKERS (MODELS 4021, manufactured by Ela Medical, Inc.. The device is a Class 1 Dental device with product code ELA cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K952363 · Ela Medical, Inc. · Dental device
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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

FDA 510(k) Submission Details - K952363

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 127d · This submission: 106d
Pathway characteristics
Predicate-based equivalence.

ELA Device Classification - Class 1, General Controls

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.