Cleared Traditional

K080338 - CUTTERSIL ACTIVATOR UNIVERSAL PLUS

K080338 is an FDA 510(k) clearance for CUTTERSIL ACTIVATOR UNIVERSAL PLUS, manufactured by Heraeus Kulzer,GmbH. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K080338 · Heraeus Kulzer,GmbH · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2008
Decision
74d
Days
Class 2
Risk

K080338 is an FDA 510(k) clearance for the CUTTERSIL ACTIVATOR UNIVERSAL PLUS. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Heraeus Kulzer,GmbH (South Bend, US). The FDA issued a Cleared decision on April 21, 2008 after a review of 74 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 - K080338

510(k) Number K080338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2008
Decision Date April 21, 2008
Days to Decision 74 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
54d faster than avg
Panel avg: 128d · This submission: 74d
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 K080338.
TEMPLATE AND COUNTER-FIT
K081017 · Clinician'S Choice Dental Products, Inc. · Aug 2008
COLORISE RIGID
K081084 · Zhermack S.P.A. · May 2008
FUTAR (FUTAR, FUTAR D, FUTAR D FAST, FUTAR D SLOW, FUTAR SCAN BITE REGISTRATION MATERIALS
K081120 · Kettenbach GmbH & Co. KG · 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
OCCLUFAST CAD
K080130 · Zhermack S.P.A. · Mar 2008
K080338 · CUTTERSIL ACTIVATOR UNIVERSAL PLUS
Download PDF FDA Summary Heraeus Kulzer,GmbH