Cleared Traditional

K011333 - CERCON CERAM

K011333 is an FDA 510(k) clearance for CERCON CERAM, manufactured by Degussa - Ney Dental, Inc.. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K011333 · Degussa - Ney Dental, Inc. · Dental device
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Aug 2001
Decision
110d
Days
Class 2
Risk

K011333 is an FDA 510(k) clearance for the CERCON CERAM. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Degussa - Ney Dental, Inc. (Bloomfield, US). The FDA issued a Cleared decision on August 20, 2001 after a review of 110 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6660 - 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 Degussa - Ney Dental, Inc. devices

FDA 510(k) Submission Details - K011333

510(k) Number K011333 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2001
Decision Date August 20, 2001
Days to Decision 110 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 127d · This submission: 110d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EIH Device Classification - Class 2, Special Controls

Product Code EIH Powder, Porcelain
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6660
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 - EIH Powder, Porcelain

All 349
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K011333.
IMAGINE H.E. PRESS DESIGN-CERAMIC
K020774 · Wieland Dental + Technik GmbH & Co. KG · May 2002
ERIS LAYERING MATERIALS
K012174 · Ivoclar North America, Inc. · Aug 2001
AVANTE MICRO CRYSTAL SYSTEM
K012231 · Jeneric/Pentron, Inc. · Aug 2001
LAVA FRAME, LAVA FRAME SHADE, LAVA CERAM
K011394 · Espe Dental AG · Jun 2001
PROCAD ADD-ON
K003373 · Ivoclar North America, Inc. · Nov 2000
HERACERAM
K002993 · J.F. Jelenko & Co., Inc. · Nov 2000