Cleared Traditional

K000983 - CERAMIX PORCELAIN SYSTEM

K000983 is an FDA 510(k) clearance for CERAMIX PORCELAIN SYSTEM, manufactured by C-Mix. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K000983 · C-Mix · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2000
Decision
152d
Days
Class 2
Risk

K000983 is an FDA 510(k) clearance for the CERAMIX PORCELAIN SYSTEM. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by C-Mix (New Port Riche, US). The FDA issued a Cleared decision on August 26, 2000 after a review of 152 days - an extended review cycle.

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.

FDA 510(k) Submission Details - K000983

510(k) Number K000983 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 2000
Decision Date August 26, 2000
Days to Decision 152 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
24d slower than avg
Panel avg: 128d · This submission: 152d
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 487
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K000983.
PROCAD ADD-ON
K003373 · Ivoclar North America, Inc. · Nov 2000
HERACERAM
K002993 · J.F. Jelenko & Co., Inc. · Nov 2000
WILLI GELLER CREATION AND LF PORCELAIN
K002904 · Jensen Industries, Inc. · Nov 2000
WILLI GELLER CREATION & AV PORCELAIN
K002041 · Jensen Industries, Inc. · Aug 2000
DC ZIRKON
K001815 · Austenal, Inc. · Aug 2000
ALUMINUM OXIDE POWDER, SUMICORUNDUM AAO4S
K001418 · Procera Sandvik, Inc. · Jul 2000
K000983 · CERAMIX PORCELAIN SYSTEM
Download PDF FDA Summary C-Mix