Cleared Abbreviated

K060334 - GI DENTSTAT

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

K060334 · Ultradent Products, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K060334

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.

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 421
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K060334.
GC XLC-100 CAPSULE
K061535 · GC America, Inc. · Jul 2006
BISCEM TRANSLUCENT, BISCEM OPAQUE
K060701 · Bisco, Inc. · May 2006
BIFIX QM
K060894 · Voco GmbH · May 2006
TEMPBOND CLEAR WITH TRICLOSAN
K053565 · Sybron Dental Specialties, Inc. · Feb 2006
PARACEM UNIVERSAL DC
K053040 · Coltene/Whaledent AG · Nov 2005
LCR
K052235 · 3M Company · Sep 2005