Cleared Traditional

K122039 - KINGSCROSS PL-C+B-10

K122039 is an FDA 510(k) clearance for KINGSCROSS PL-C+B-10, manufactured by Kettenbach GmbH & Co. KG. The device is a Class 2 Dental device with product code EBG cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K122039 · Kettenbach GmbH & Co. KG · Dental device
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Dec 2012
Decision
169d
Days
Class 2
Risk

K122039 is an FDA 510(k) clearance for the KINGSCROSS PL-C+B-10, KINGSCROSS PL-C+B-12, KINGSCROSS PL-C+B-08, KINGSCROSS B. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Kettenbach GmbH & Co. KG (Eschenburg, DE). The FDA issued a Cleared decision on December 27, 2012 after a review of 169 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3770 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Kettenbach GmbH & Co. KG devices

FDA 510(k) Submission Details - K122039

510(k) Number K122039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2012
Decision Date December 27, 2012
Days to Decision 169 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
42d slower than avg
Panel avg: 127d · This submission: 169d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBG Device Classification - Class 2, Special Controls

Product Code EBG Crown And Bridge, Temporary, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3770
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 - EBG Crown And Bridge, Temporary, Resin

All 113
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K122039.
TEMP BASIC, TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE, THERAPON, TRY-IN, BURNOUT, TRY-IN & BURNOUT
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