Cleared Traditional

K161652 - DIAZIR (FDA 510(k) Clearance)

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

K161652 · Zxtgy (Beijing) Technology Co., Ltd. · Dental device
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Nov 2017
Decision
531d
Days
Class 2
Risk

K161652 is an FDA 510(k) clearance for the DIAZIR. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Zxtgy (Beijing) Technology Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on November 28, 2017 after a review of 531 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 Zxtgy (Beijing) Technology Co., Ltd. devices

Submission Details

510(k) Number K161652 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2016
Decision Date November 28, 2017
Days to Decision 531 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
404d slower than avg
Panel avg: 127d · This submission: 531d
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

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