Cleared Traditional

ORTHO-BITE WAX WAFER (K863758) - FDA 510(k) Clearance

Class I Dental device.

K863758 · Columbus Dental Mfg. Co. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1986
Decision
12d
Days
Class 1
Risk

K863758 is an FDA 510(k) clearance for the ORTHO-BITE WAX WAFER. Classified as Wax, Dental, Intraoral (product code EGD), Class I - General Controls.

Submitted by Columbus Dental Mfg. Co. (St. Louis, US). The FDA issued a Cleared decision on October 7, 1986 after a review of 12 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6890 - 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 Columbus Dental Mfg. Co. devices

Submission Details

510(k) Number K863758 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1986
Decision Date October 07, 1986
Days to Decision 12 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 127d · This submission: 12d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EGD Wax, Dental, Intraoral
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6890
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.