Cleared Traditional

K082591 - FLEXITIME BITE

K082591 is an FDA 510(k) clearance for FLEXITIME BITE, manufactured by Heraeus Kulzer, Inc., Dental Products Division. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K082591 · Heraeus Kulzer, Inc., Dental Products Division · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2008
Decision
88d
Days
Class 2
Risk

K082591 is an FDA 510(k) clearance for the FLEXITIME BITE. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Heraeus Kulzer, Inc., Dental Products Division (South Bend, US). The FDA issued a Cleared decision on December 5, 2008 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3660 - 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 Heraeus Kulzer, Inc., Dental Products Division devices

FDA 510(k) Submission Details - K082591

510(k) Number K082591 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2008
Decision Date December 05, 2008
Days to Decision 88 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 127d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELW Device Classification - Class 2, Special Controls

Product Code ELW Material, Impression
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3660
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 - ELW Material, Impression

All 265
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K082591.
FLEXITIME FLOW
K091494 · Heraeus Kulzer, Inc. · Jul 2009
VONFLEX PUTTY
K091267 · Vericom Co., Ltd. · May 2009
HYDRORISE AND HYDROSYSTEM
K083739 · Zhermack S.P.A. · Mar 2009
COLORISE RIGID
K081084 · Zhermack S.P.A. · May 2008
CEREC OPTI SPRAY
K080882 · Sirona Dental Systems GmbH · Apr 2008
PECD-01 AND PECD QUICK-01
K080514 · 3M Espe AG Dental Products · Mar 2008