Cleared Traditional

K833310 - FOGCUTTER DENTAL MOUTH MIRROR

K833310 is an FDA 510(k) clearance for FOGCUTTER DENTAL MOUTH MIRROR, manufactured by Hti, Inc.. The device is a Class 1 Dental device with product code EAX cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K833310 · Hti, Inc. · Dental device
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May 1984
Decision
224d
Days
Class 1
Risk

K833310 is an FDA 510(k) clearance for the FOGCUTTER DENTAL MOUTH MIRROR. Classified as Mirror, Mouth (product code EAX), Class I - General Controls.

Submitted by Hti, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 7, 1984 after a review of 224 days - an extended review cycle.

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 Hti, Inc. devices

FDA 510(k) Submission Details - K833310

510(k) Number K833310 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 1983
Decision Date May 07, 1984
Days to Decision 224 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d slower than avg
Panel avg: 128d · This submission: 224d
Pathway characteristics
Predicate-based equivalence.

EAX Device Classification - Class 1, General Controls

Product Code EAX Mirror, Mouth
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.