Cleared Special

K080768 - ULTRATEMP FIRM, FAST AND REGULAR SET

K080768 is an FDA 510(k) clearance for ULTRATEMP FIRM, manufactured by Ultradent Products, Inc.. The device is a Class 2 Dental device with product code EMA cleared through the Special 510(k) pathway after a 24-day FDA review.

K080768 · Ultradent Products, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2008
Decision
24d
Days
Class 2
Risk

K080768 is an FDA 510(k) clearance for the ULTRATEMP FIRM, FAST AND REGULAR SET. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on April 11, 2008 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3275 - 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.

View all Ultradent Products, Inc. devices

FDA 510(k) Submission Details - K080768

510(k) Number K080768 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2008
Decision Date April 11, 2008
Days to Decision 24 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
103d faster than avg
Panel avg: 127d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

EMA Device Classification - Class 2, Special Controls

Product Code EMA Cement, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3275
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 - EMA Cement, Dental

All 419
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