Cleared Traditional

PREVI DENT PROPHYLAXIS MINT NDC (K780834) - FDA 510(k) Clearance

Class I Dental device.

K780834 · Hoyt Laboratories · Dental device
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Jun 1978
Decision
9d
Days
Class 1
Risk

K780834 is an FDA 510(k) clearance for the PREVI DENT PROPHYLAXIS MINT NDC. Classified as Agent, Polishing, Abrasive, Oral Cavity (product code EJR), Class I - General Controls.

Submitted by Hoyt Laboratories (Mchenry, US). The FDA issued a Cleared decision on June 2, 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 872.6030 - 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 Hoyt Laboratories devices

Submission Details

510(k) Number K780834 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 1978
Decision Date June 02, 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 EJR Agent, Polishing, Abrasive, Oral Cavity
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6030
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.