Cleared Traditional

SILVERAK (K833838) - FDA 510(k) Clearance

Class I Dental device.

K833838 · Anil S. Gautam · Dental device
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Mar 1984
Decision
120d
Days
Class 1
Risk

K833838 is an FDA 510(k) clearance for the SILVERAK. Classified as Scraper, Tongue (product code LCN), Class I - General Controls.

Submitted by Anil S. Gautam (Mchenry, US). The FDA issued a Cleared decision on March 2, 1984 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6855 - 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 Anil S. Gautam devices

Submission Details

510(k) Number K833838 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1983
Decision Date March 02, 1984
Days to Decision 120 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 127d · This submission: 120d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LCN Scraper, Tongue
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6855
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.