Cleared Traditional

K081120 - FUTAR (FUTAR, FUTAR D, FUTAR D FAST, FUTAR D SLOW, FUTAR SCAN BITE REGISTRATION MATERIALS

K081120 is an FDA 510(k) clearance for FUTAR (FUTAR, manufactured by Kettenbach GmbH & Co. KG. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K081120 · Kettenbach GmbH & Co. KG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
10d
Days
Class 2
Risk

K081120 is an FDA 510(k) clearance for the FUTAR (FUTAR, FUTAR D, FUTAR D FAST, FUTAR D SLOW, FUTAR SCAN BITE REGISTRATI.... Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Kettenbach GmbH & Co. KG (Eschenburg, DE). The FDA issued a Cleared decision on May 1, 2008 after a review of 10 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 Kettenbach GmbH & Co. KG devices

FDA 510(k) Submission Details - K081120

510(k) Number K081120 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2008
Decision Date May 01, 2008
Days to Decision 10 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 128d · This submission: 10d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Tuv Sud America, Inc.
STEFAN PREISS

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - ELW Material, Impression

All 342
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K081120.
KETTOSIL AND SILGINAT
K082157 · Kettenbach GmbH & Co. KG · Aug 2008
TEMPLATE AND COUNTER-FIT
K081017 · Clinician'S Choice Dental Products, Inc. · Aug 2008
COLORISE RIGID
K081084 · Zhermack S.P.A. · May 2008
CUTTERSIL ACTIVATOR UNIVERSAL PLUS
K080338 · Heraeus Kulzer,GmbH · Apr 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