Cleared Traditional

K033996 - HERMES

K033996 is an FDA 510(k) clearance for HERMES, manufactured by 3M Espe AG Dental Products. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K033996 · 3M Espe AG Dental Products · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2004
Decision
62d
Days
Class 2
Risk

K033996 is an FDA 510(k) clearance for the HERMES. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by 3M Espe AG Dental Products (Bavaria D-82228 Seefeld, DE). The FDA issued a Cleared decision on February 24, 2004 after a review of 62 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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 3M Espe AG Dental Products devices

FDA 510(k) Submission Details - K033996

510(k) Number K033996 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 2003
Decision Date February 24, 2004
Days to Decision 62 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
65d faster than avg
Panel avg: 127d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBF Device Classification - Class 2, Special Controls

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 - EBF Material, Tooth Shade, Resin

All 645
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K033996.
MULTICORE HB
K040795 · Ivoclar Vivadent, Inc. · May 2004
QUIXX POSTERIOR RESTORATIVE
K040144 · Dentsply International · Apr 2004
CLEARFIL PHOTO CORE PLT
K033970 · Kuraray Medical, Inc. · Mar 2004
GRADIA GUM
K033808 · GC America, Inc. · Feb 2004
CONCEPT HP ADD-ON
K033773 · Ivoclar Vivadent, AG · Jan 2004
VENUS FLOW
K033665 · Heraeus Kulzer, Inc. · Dec 2003