Cleared Traditional

K153767 - X-cera Zirconia Blanks

K153767 is an FDA 510(k) clearance for X-cera Zirconia Blanks, manufactured by Shenzhen Xiangtong Photoelectricity Technology Co., Ltd.. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K153767 · Shenzhen Xiangtong Photoelectricity Technology Co., Ltd. · Dental device
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Mar 2016
Decision
90d
Days
Class 2
Risk

K153767 is an FDA 510(k) clearance for the X-cera Zirconia Blanks. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Shenzhen Xiangtong Photoelectricity Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on March 29, 2016 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Shenzhen Xiangtong Photoelectricity Technology Co., Ltd. devices

FDA 510(k) Submission Details - K153767

510(k) Number K153767 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2015
Decision Date March 29, 2016
Days to Decision 90 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 127d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Peers - EIH Powder, Porcelain

All 279
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