Cleared Traditional

K841011 - ELEVATOR - VARIOUS (FDA 510(k) Clearance)

Class I Dental device.

K841011 · Premier Dental Products Co. · Dental device
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Jun 1984
Decision
98d
Days
Class 1
Risk

K841011 is an FDA 510(k) clearance for the ELEVATOR - VARIOUS. Classified as Curette, Periodontic (product code EMS), Class I - General Controls.

Submitted by Premier Dental Products Co. (Mchenry, US). The FDA issued a Cleared decision on June 15, 1984 after a review of 98 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 Premier Dental Products Co. devices

Submission Details

510(k) Number K841011 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1984
Decision Date June 15, 1984
Days to Decision 98 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 127d · This submission: 98d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EMS Curette, Periodontic
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.