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)
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.

View all Ultradent Products, Inc. devices

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
9d slower than avg
Panel avg: 127d · 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 102
Devices cleared under the same product code (EBC) and FDA review panel - the closest regulatory comparables to K101245.
BEAUTISEALANT
K111782 · Shofu Dental Corporation · Sep 2011
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K110058 · Novocol Inc. Dba Septodont and Confi-Dental Produc · Mar 2011
ECO-S
K103121 · Vericom Co., Ltd. · Oct 2010
INFILTRATION KIT
K100062 · Dmg USA, Inc. · Mar 2010
SPK SEALANT
K091632 · 3M Company · Sep 2009
INFILTRATION KIT
K081493 · Dmg USA, Inc. · Sep 2008