Cleared Traditional

K073040 - SMH FLEX S

K073040 is an FDA 510(k) clearance for SMH FLEX S, manufactured by Smh Biomaterial AG. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K073040 · Smh Biomaterial AG · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2007
Decision
45d
Days
Class 2
Risk

K073040 is an FDA 510(k) clearance for the SMH FLEX S. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Smh Biomaterial AG (Denton, US). The FDA issued a Cleared decision on December 13, 2007 after a review of 45 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 - K073040

510(k) Number K073040 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 2007
Decision Date December 13, 2007
Days to Decision 45 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
83d faster than avg
Panel avg: 128d · This submission: 45d
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 K073040.
MAJOR.BASE 20
K081884 · Major Prodotti Dentari S.P.A. · Oct 2008
TEMPO CUSHION TREATMENT DENTURE RELINE ACRYLIC RESIN LIQUID, PROFESSIONAL SIZE PACKAGE AND POWDER
K081514 · Lang Dental Mfg. Co., Inc. · Sep 2008
POLYSTAR 79 DENTURE BASE RESIN
K072851 · Cmp Industries, LLC · Feb 2008
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
FLEX-STAR V
K072402 · Cmp Industries, LLC · Oct 2007
K073040 · SMH FLEX S
Download PDF FDA Summary Smh Biomaterial AG