Cleared Traditional

LUXEN Zr, LUXEN Smile (K171585) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K171585 · Dentalmax Co., Ltd. · Dental device
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Oct 2018
Decision
518d
Days
Class 2
Risk

K171585 is an FDA 510(k) clearance for the LUXEN Zr, LUXEN Smile. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Dentalmax Co., Ltd. (Cheonan-Si, KR). The FDA issued a Cleared decision on October 31, 2018 after a review of 518 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6660 - 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 Dentalmax Co., Ltd. devices

Submission Details

510(k) Number K171585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2017
Decision Date October 31, 2018
Days to Decision 518 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
391d slower than avg
Panel avg: 127d · This submission: 518d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EIH Powder, Porcelain
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6660
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - EIH Powder, Porcelain

All 184
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K171585.
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