Cleared Traditional

K011239 - GINDA GUARD

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

K011239 · Cosmedent, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K011239

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.

EBD Device Classification - Class 2, Special Controls

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 46
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
BELLEGLAZE
K992067 · Kerr Dental Materials Center · Aug 1999
CORE-IDE
K984037 · Roydent Dental Products, Inc. · Feb 1999