Cleared Traditional

K082157 - KETTOSIL AND SILGINAT

K082157 is an FDA 510(k) clearance for KETTOSIL AND SILGINAT, 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 6-day FDA review.

K082157 · Kettenbach GmbH & Co. KG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2008
Decision
6d
Days
Class 2
Risk

K082157 is an FDA 510(k) clearance for the KETTOSIL AND SILGINAT. 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 August 6, 2008 after a review of 6 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 - K082157

510(k) Number K082157 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2008
Decision Date August 06, 2008
Days to Decision 6 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
122d faster than avg
Panel avg: 128d · This submission: 6d
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 K082157.
PANASIL INITIAL CONTACT AND PANASIL TRAY
K083701 · Kettenbach GmbH & Co. KG · Jan 2009
FLEXITIME BITE
K082591 · Heraeus Kulzer, Inc., Dental Products Division · Dec 2008
PANASIL IMPRESSION MATERIALS, INCLUDING PUTTY, BINETICS, TRAY, MONOPHASE AND CONTACT
K082560 · Kettenbach GmbH & Co. KG · Sep 2008
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