Cleared Traditional

K011239 - GINDA GUARD

K011239 is the FDA 510(k) clearance for GINDA GUARD by Cosmedent, Inc.. It is a Class 2 Dental device (product code EBD) cleared through the Traditional 510(k) pathway after a 297-day FDA review.

K011239 · Cosmedent, Inc. · Dental device
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Feb 2002
Decision
297d
Days
Class 2
Risk

K011239 is an FDA 510(k) clearance for the GINDA GUARD. Classified as Coating, Filling Material, Resin (product code EBD), Class II - Special Controls.

Submitted by Cosmedent, Inc. (Chicago, US). The FDA issued a Cleared decision on February 14, 2002 after a review of 297 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3310 - 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 Cosmedent, Inc. devices

Submission Details

510(k) Number K011239 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2001
Decision Date February 14, 2002
Days to Decision 297 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
170d slower than avg
Panel avg: 127d · This submission: 297d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBD Coating, Filling Material, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3310
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 - EBD Coating, Filling Material, Resin

All 38
Devices cleared under the same product code (EBD) and FDA review panel - the closest regulatory comparables to K011239.
BISCOVER LIQUID POLISH KIT, BISCOVER LIQUID POLISH AND BISCOVER VISCOSITY MODIFIER
K030354 · Bisco, Inc. · Feb 2003
TESCERA GLAZING RESIN, MODEL T-1804, BISCOVER XT, MODEL G-93220P
K024046 · Bisco, Inc. · Feb 2003
UNINHIBITED
K021503 · Bisco, Inc. · Aug 2002
LUXAGLAZE
K013179 · Dmg USA, Inc. · Oct 2001
FLOWABLE HYBRID
K980298 · Cosmedent, Inc. · Mar 1998
RENAMEL FLOWABLE COMPOSITE
K974494 · Cosmedent, Inc. · Feb 1998