Cleared Traditional

K851006 - T-SWIPE -TONGUE CLEANER

K851006 is an FDA 510(k) clearance for T-SWIPE -TONGUE CLEANER, manufactured by Kumar Ent.. The device is a Class 1 Dental device with product code LCN cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K851006 · Kumar Ent. · Dental device
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May 1985
Decision
70d
Days
Class 1
Risk

K851006 is an FDA 510(k) clearance for the T-SWIPE -TONGUE CLEANER. Classified as Scraper, Tongue (product code LCN), Class I - General Controls.

Submitted by Kumar Ent. (Foster City, US). The FDA issued a Cleared decision on May 21, 1985 after a review of 70 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Kumar Ent. devices

FDA 510(k) Submission Details - K851006

510(k) Number K851006 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1985
Decision Date May 21, 1985
Days to Decision 70 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 128d · This submission: 70d
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.