Cleared Special

K101245 - ULTRASEAL ID

K101245 is an FDA 510(k) clearance for ULTRASEAL ID, 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 136-day FDA review.

K101245 · Ultradent Products, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2010
Decision
136d
Days
Class 2
Risk

K101245 is an FDA 510(k) clearance for the ULTRASEAL ID. 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 17, 2010 after a review of 136 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 - K101245

510(k) Number K101245 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2010
Decision Date September 17, 2010
Days to Decision 136 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
8d slower than avg
Panel avg: 128d · This submission: 136d
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 K101245.
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
ECO-S
K103121 · Vericom Co., Ltd. · Oct 2010
INFILTRATION KIT
K100062 · Dmg USA, Inc. · Mar 2010
SELECT DEFENSE DENTAL PIT AND FISSURE SEALANT
K093059 · Classone Orthodontics, Inc. · Feb 2010
SPK SEALANT
K091632 · 3M Company · Sep 2009
K101245 · ULTRASEAL ID
Download PDF FDA Summary Ultradent Products, I…