Cleared Traditional

K024287 - FIXOBRIDGE 3-CEMENT

K024287 is an FDA 510(k) clearance for FIXOBRIDGE 3-CEMENT, manufactured by Advanced Healthcare , Ltd.. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K024287 · Advanced Healthcare , Ltd. · Dental device
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Mar 2003
Decision
88d
Days
Class 2
Risk

K024287 is an FDA 510(k) clearance for the FIXOBRIDGE 3-CEMENT. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Advanced Healthcare , Ltd. (Hot Springs, US). The FDA issued a Cleared decision on March 21, 2003 after a review of 88 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 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 Advanced Healthcare , Ltd. devices

FDA 510(k) Submission Details - K024287

510(k) Number K024287 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2002
Decision Date March 21, 2003
Days to Decision 88 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
40d faster than avg
Panel avg: 128d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 451
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K024287.
TEMPORARY RESIN CEMENT
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RIVA-SELF CURE
K030516 · Southern Dental Industries, Inc. · Apr 2003
AGC CEM
K030168 · Wieland Dental + Technik GmbH & Co. KG · Mar 2003
CIMOFLUOR
K023888 · Global Dental Products, Inc. · Mar 2003
AHL GENERIC GLASS IONOMER LUTING CEMENT
K023981 · Advanced Healthcare , Ltd. · Jan 2003