Cleared Traditional

K162888 - Cercon

K162888 is the FDA 510(k) clearance for Cercon by Dentsply Sirona. It is a Class 2 Dental device (product code EIH) cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K162888 · Dentsply Sirona · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2017
Decision
130d
Days
Class 2
Risk

K162888 is an FDA 510(k) clearance for the Cercon. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Dentsply Sirona (York, US). The FDA issued a Cleared decision on February 24, 2017 after a review of 130 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 Dentsply Sirona devices

Submission Details

510(k) Number K162888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2016
Decision Date February 24, 2017
Days to Decision 130 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
3d slower than avg
Panel avg: 127d · This submission: 130d
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 199
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