Cleared Traditional

K161652 - DIAZIR

K161652 is an FDA 510(k) clearance for DIAZIR, manufactured by Zxtgy (Beijing) Technology Co., Ltd.. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 531-day FDA review.

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.

FDA 510(k) Submission Details - K161652

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
403d slower than avg
Panel avg: 128d · This submission: 531d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EIH Device Classification - Class 2, Special Controls

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 Consultant

Promy Chemical, Inc.
JOHN G. HUANG

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EIH Powder, Porcelain

All 471
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