Cleared Traditional

K790895 - TONGUE SCRAPER

K790895 is an FDA 510(k) clearance for TONGUE SCRAPER, manufactured by Peter G. Finamore, Sr.. The device is a Class 1 Dental device with product code LCN cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K790895 · Peter G. Finamore, Sr. · Dental device
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Sep 1979
Decision
120d
Days
Class 1
Risk

K790895 is an FDA 510(k) clearance for the TONGUE SCRAPER. Classified as Scraper, Tongue (product code LCN), Class I - General Controls.

Submitted by Peter G. Finamore, Sr. (Mchenry, US). The FDA issued a Cleared decision on September 4, 1979 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 Peter G. Finamore, Sr. devices

FDA 510(k) Submission Details - K790895

510(k) Number K790895 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1979
Decision Date September 04, 1979
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
8d faster than avg
Panel avg: 128d · This submission: 120d
Pathway characteristics
Predicate-based equivalence.

LCN Device Classification - Class 1, General Controls

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.