Cleared Traditional

K902838 - DENTURE DYNAMIC'S DENTURE MAGIC

K902838 is an FDA 510(k) clearance for DENTURE DYNAMIC'S DENTURE MAGIC, manufactured by Denture Dynamic'S, Inc.. The device is a Class 1 Dental device with product code EFT cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K902838 · Denture Dynamic'S, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1990
Decision
70d
Days
Class 1
Risk

K902838 is an FDA 510(k) clearance for the DENTURE DYNAMIC'S DENTURE MAGIC. Classified as Cleanser, Denture, Over The Counter (product code EFT), Class I - General Controls.

Submitted by Denture Dynamic'S, Inc. (Keizer, US). The FDA issued a Cleared decision on September 6, 1990 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3520 - 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 Denture Dynamic'S, Inc. devices

FDA 510(k) Submission Details - K902838

510(k) Number K902838 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1990
Decision Date September 06, 1990
Days to Decision 70 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 127d · This submission: 70d
Pathway characteristics
Predicate-based equivalence.

EFT Device Classification - Class 1, General Controls

Product Code EFT Cleanser, Denture, Over The Counter
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3520
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.