Cleared Special

K112517 - ULTRASEAL XT HYDRO

K112517 is an FDA 510(k) clearance for ULTRASEAL XT HYDRO, manufactured by Ultradent Products, Inc.. The device is a Class 2 Dental device with product code EBC cleared through the Special 510(k) pathway after a 23-day FDA review.

K112517 · Ultradent Products, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2011
Decision
23d
Days
Class 2
Risk

K112517 is an FDA 510(k) clearance for the ULTRASEAL XT HYDRO. Classified as Sealant, Pit And Fissure, And Conditioner (product code EBC), Class II - Special Controls.

Submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on September 23, 2011 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3765 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K112517

510(k) Number K112517 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2011
Decision Date September 23, 2011
Days to Decision 23 days
Submission Type Special
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
105d faster than avg
Panel avg: 128d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

EBC Device Classification - Class 2, Special Controls

Product Code EBC Sealant, Pit And Fissure, And Conditioner
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3765
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 - EBC Sealant, Pit And Fissure, And Conditioner

All 125
Devices cleared under the same product code (EBC) and FDA review panel - the closest regulatory comparables to K112517.
CONTROL SEAL
K130485 · Voco GmbH · Feb 2014
PREVENT SEAL
K122521 · Itena Clinical · Jun 2013
EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILL
K113818 · Pulpdent Corporation · Mar 2012
BEAUTISEALANT
K111782 · Shofu Dental Corporation · Sep 2011
BPA-FREE PIT AND FISSURE SEALANT
K110058 · Novocol Inc. Dba Septodont and Confi-Dental Produc · Mar 2011
DMP PIT & FISSURE SEALANT
K102252 · Dmp, Ltd. · Dec 2010
K112517 · ULTRASEAL XT HYDRO
Download PDF FDA Summary Ultradent Products, I…