Cleared Traditional

K133088 - ZX-27 (FDA 510(k) Clearance)

Class I Dental device.

K133088 · M&M Dental Studio, Inc. · Dental device
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Jan 2015
Decision
459d
Days
Class 1
Risk

K133088 is an FDA 510(k) clearance for the ZX-27. Classified as Anchor, Preformed (product code EJX), Class I - General Controls.

Submitted by M&M Dental Studio, Inc. (New York, US). The FDA issued a Cleared decision on January 2, 2015 after a review of 459 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3130 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all M&M Dental Studio, Inc. devices

Submission Details

510(k) Number K133088 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2013
Decision Date January 02, 2015
Days to Decision 459 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
332d slower than avg
Panel avg: 127d · This submission: 459d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EJX Anchor, Preformed
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3130
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.