Cleared Traditional

K211905 - UltraCal XS

K211905 is an FDA 510(k) clearance for UltraCal XS, manufactured by Ultradent Products, Inc.. The device is a Class 2 Dental device with product code KIF cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K211905 · Ultradent Products, Inc. · Dental device
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Oct 2021
Decision
114d
Days
Class 2
Risk

K211905 is an FDA 510(k) clearance for the UltraCal XS. Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on October 13, 2021 after a review of 114 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3820 - 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 Ultradent Products, Inc. devices

FDA 510(k) Submission Details - K211905

510(k) Number K211905 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2021
Decision Date October 13, 2021
Days to Decision 114 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
13d faster than avg
Panel avg: 127d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KIF Device Classification - Class 2, Special Controls

Product Code KIF Resin, Root Canal Filling
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3820
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 - KIF Resin, Root Canal Filling

All 124
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