Cleared Traditional

K072402 - FLEX-STAR V

K072402 is an FDA 510(k) clearance for FLEX-STAR V, manufactured by Cmp Industries, LLC. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K072402 · Cmp Industries, LLC · Dental device
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Oct 2007
Decision
53d
Days
Class 2
Risk

K072402 is an FDA 510(k) clearance for the FLEX-STAR V. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Cmp Industries, LLC (Albany, US). The FDA issued a Cleared decision on October 19, 2007 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3760 - 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.

FDA 510(k) Submission Details - K072402

510(k) Number K072402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2007
Decision Date October 19, 2007
Days to Decision 53 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
75d faster than avg
Panel avg: 128d · This submission: 53d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBI Device Classification - Class 2, Special Controls

Product Code EBI Resin, Denture, Relining, Repairing, Rebasing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3760
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 - EBI Resin, Denture, Relining, Repairing, Rebasing

All 311
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K072402.
SMH FLEX S
K073040 · Smh Biomaterial AG · Dec 2007
FLEXITE SUPREME, FLEXITE PLUS, FLEXITE M.P., NORTHERN AND FLEXITE PRO-GUARD
K072479 · Rapid Injection Systems Corp. · Nov 2007
JET DENTURE REPAIR POWDER MEHARRY 100,454 GRAMS, JET DENTURE REPAIR PROFESSIONAL PACKAGE 100 GRAMS/118ML, 1220,30,23
K072580 · Lang Dental Mfg. Co., Inc. · Nov 2007
ION DENTAL RESIN SYSTEM
K072713 · Dentsply International, Inc. · Oct 2007
TALON AND REVERE
K071245 · Talon Acrylics, Inc. · Aug 2007
COE SOFT
K070697 · GC America, Inc. · Mar 2007
K072402 · FLEX-STAR V
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