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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 128d · 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 375
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K082591.
VONFLEX PUTTY
K091267 · Vericom Co., Ltd. · May 2009
HYDRORISE AND HYDROSYSTEM
K083739 · Zhermack S.P.A. · Mar 2009
PANASIL INITIAL CONTACT AND PANASIL TRAY
K083701 · Kettenbach GmbH & Co. KG · Jan 2009
PANASIL IMPRESSION MATERIALS, INCLUDING PUTTY, BINETICS, TRAY, MONOPHASE AND CONTACT
K082560 · Kettenbach GmbH & Co. KG · Sep 2008
KETTOSIL AND SILGINAT
K082157 · Kettenbach GmbH & Co. KG · Aug 2008
TEMPLATE AND COUNTER-FIT
K081017 · Clinician'S Choice Dental Products, Inc. · Aug 2008
K082591 · FLEXITIME BITE
Download PDF FDA Summary Heraeus Kulzer, Inc.,…