Cleared Traditional

K161213 - XSmart iQ

K161213 is the FDA 510(k) clearance for XSmart iQ by Dentsply Sirona. It is a Class 1 Dental device (product code EBW) cleared through the Traditional 510(k) pathway after a 287-day FDA review.

K161213 · Dentsply Sirona · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2017
Decision
287d
Days
Class 1
Risk

K161213 is an FDA 510(k) clearance for the XSmart iQ. Classified as Controller, Foot, Handpiece And Cord (product code EBW), Class I - General Controls.

Submitted by Dentsply Sirona (York, US). The FDA issued a Cleared decision on February 10, 2017 after a review of 287 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - 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 K161213 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2016
Decision Date February 10, 2017
Days to Decision 287 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
160d slower than avg
Panel avg: 127d · This submission: 287d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EBW Controller, Foot, Handpiece And Cord
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EBW Controller, Foot, Handpiece And Cord

All 23
Devices cleared under the same product code (EBW) and FDA review panel - the closest regulatory comparables to K161213.
Maxima Electric System
K180845 · Handpiece Headquarters - Hpr, Inc. · Jul 2019
Electric Handpiece Motor
K181858 · W&H Dentalwerk Buermoos GmbH · Mar 2019
Surgic Pro, Surgic Pro+
K173905 · Nakanishi, Inc. · Jun 2018
A-DEC/W&H ELECTRIC HANDPIECE MOTOR
K133776 · A-Dec, Inc. · May 2014
A-DEC/W&H ELECTRIC MOTOR, MODEL EA-50LT
K032572 · A-Dec, Inc. · Dec 2003