Cleared Traditional

K863816 - IVORY PREMIUM RUBBER DAM

K863816 is an FDA 510(k) clearance for IVORY PREMIUM RUBBER DAM, manufactured by Columbus Dental Mfg. Co.. The device is a Class 1 Dental device with product code EIE cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K863816 · Columbus Dental Mfg. Co. · Dental device
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Oct 1986
Decision
27d
Days
Class 1
Risk

K863816 is an FDA 510(k) clearance for the IVORY PREMIUM RUBBER DAM. Classified as Dam, Rubber (product code EIE), Class I - General Controls.

Submitted by Columbus Dental Mfg. Co. (St. Louis, US). The FDA issued a Cleared decision on October 27, 1986 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6300 - 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

FDA 510(k) Submission Details - K863816

510(k) Number K863816 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1986
Decision Date October 27, 1986
Days to Decision 27 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 128d · This submission: 27d
Pathway characteristics
Predicate-based equivalence.

EIE Device Classification - Class 1, General Controls

Product Code EIE Dam, Rubber
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6300
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.