Cleared Traditional

PROPHY CUPS, R&R (K780198) - FDA 510(k) Clearance

Class I Dental device.

K780198 · Ransom and Randolph · Dental device
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Feb 1978
Decision
9d
Days
Class 1
Risk

K780198 is an FDA 510(k) clearance for the PROPHY CUPS, R&R. Classified as Cup, Prophylaxis (product code EHK), Class I - General Controls.

Submitted by Ransom and Randolph (Mchenry, US). The FDA issued a Cleared decision on February 16, 1978 after a review of 9 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6290 - 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 Ransom and Randolph devices

Submission Details

510(k) Number K780198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1978
Decision Date February 16, 1978
Days to Decision 9 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 127d · This submission: 9d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EHK Cup, Prophylaxis
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6290
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.