Cleared Abbreviated

K060334 - GI DENTSTAT

K060334 is the FDA 510(k) clearance for GI DENTSTAT by Ultradent Products, Inc.. It is a Class 2 Dental device (product code EMA) cleared through the Abbreviated 510(k) pathway after a 14-day FDA review.

K060334 · Ultradent Products, Inc. · Dental device
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Feb 2006
Decision
14d
Days
Class 2
Risk

K060334 is an FDA 510(k) clearance for the GI DENTSTAT. 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 February 23, 2006 after a review of 14 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. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Ultradent Products, Inc. devices

Submission Details

510(k) Number K060334 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 2006
Decision Date February 23, 2006
Days to Decision 14 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
113d faster than avg
Panel avg: 127d · This submission: 14d
Pathway characteristics
Standards-based clearance path.

Device Classification

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 254
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