Cleared Traditional

K081537 - CFS FLEXIBLE

K081537 is an FDA 510(k) clearance for CFS FLEXIBLE, manufactured by Comfort and Flexible Systems. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 234-day FDA review.

K081537 · Comfort and Flexible Systems · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2009
Decision
234d
Days
Class 2
Risk

K081537 is an FDA 510(k) clearance for the CFS FLEXIBLE. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Comfort and Flexible Systems (Roswell, US). The FDA issued a Cleared decision on January 22, 2009 after a review of 234 days - an extended review 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: 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.

FDA 510(k) Submission Details - K081537

510(k) Number K081537 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2008
Decision Date January 22, 2009
Days to Decision 234 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
106d slower than avg
Panel avg: 128d · This submission: 234d
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 312
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K081537.
JET XR RADIOPAQUE ACRYLIC RESIN POWDER 45 GRAMS, JET XR RADIOPAQUE ACRYLIC RESIN POWDER 100 GRAMS, JET LIQUID 118 ML MOD
K100653 · Lang Dental Mfg. Co., Inc. · Oct 2010
TOKUYAMA TISSUECARE
K081554 · Tokuyama Dental Corporation · Mar 2009
BIOCRYL X
K083479 · Great Lakes Orthodontics, Ltd. · Feb 2009
PERMA FIBER,MODEL 441
K082180 · Angelus Industria DE Productos Odontologicos · Dec 2008
MAJOR.REPAIR
K082153 · Major Prodotti Dentari S.P.A. · Nov 2008
LANG DENTAL ACRYLIC PRIMER
K081981 · Lang Dental Mfg. Co., Inc. · Nov 2008
K081537 · CFS FLEXIBLE
Download PDF FDA Summary Comfort and Flexible …