Cleared Traditional

K854765 - INSTA-TOOTH SPLINT BAR WITH & WITHOUT TEETH

K854765 is an FDA 510(k) clearance for INSTA-TOOTH SPLINT BAR WITH & WITHOUT TEETH, manufactured by C&C Systems, Inc.. The device is a Class 1 Dental device with product code EHP cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K854765 · C&C Systems, Inc. · Dental device
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Jun 1986
Decision
198d
Days
Class 1
Risk

K854765 is an FDA 510(k) clearance for the INSTA-TOOTH SPLINT BAR WITH & WITHOUT TEETH. Classified as Clasp, Preformed (product code EHP), Class I - General Controls.

Submitted by C&C Systems, Inc. (Washington, US). The FDA issued a Cleared decision on June 13, 1986 after a review of 198 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3285 - 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 C&C Systems, Inc. devices

FDA 510(k) Submission Details - K854765

510(k) Number K854765 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1985
Decision Date June 13, 1986
Days to Decision 198 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d slower than avg
Panel avg: 128d · This submission: 198d
Pathway characteristics
Predicate-based equivalence.

EHP Device Classification - Class 1, General Controls

Product Code EHP Clasp, Preformed
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3285
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.