Cleared Traditional

K060881 - TEMPORARY CROWN & BRIDGE RESIN

K060881 is an FDA 510(k) clearance for TEMPORARY CROWN & BRIDGE RESIN, manufactured by Cosmedent, Inc.. The device is a Class 2 Dental device with product code EBG cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K060881 · Cosmedent, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
46d
Days
Class 2
Risk

K060881 is an FDA 510(k) clearance for the TEMPORARY CROWN & BRIDGE RESIN. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Cosmedent, Inc. (Chicago, US). The FDA issued a Cleared decision on May 16, 2006 after a review of 46 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3770 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cosmedent, Inc. devices

FDA 510(k) Submission Details - K060881

510(k) Number K060881 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2006
Decision Date May 16, 2006
Days to Decision 46 days
Submission Type Traditional
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
81d faster than avg
Panel avg: 127d · This submission: 46d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBG Device Classification - Class 2, Special Controls

Product Code EBG Crown And Bridge, Temporary, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3770
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 - EBG Crown And Bridge, Temporary, Resin

All 150
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K060881.
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K052800 · Dmg USA, Inc. · Mar 2006
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SYSTEMP.C&B PLUS
K042820 · Ivoclar Vivadent, Inc. · Dec 2004