Cleared Traditional

K012231 - AVANTE MICRO CRYSTAL SYSTEM

K012231 is an FDA 510(k) clearance for AVANTE MICRO CRYSTAL SYSTEM, manufactured by Jeneric/Pentron, Inc.. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K012231 · Jeneric/Pentron, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
38d
Days
Class 2
Risk

K012231 is an FDA 510(k) clearance for the AVANTE MICRO CRYSTAL SYSTEM. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Jeneric/Pentron, Inc. (Wallingford, US). The FDA issued a Cleared decision on August 23, 2001 after a review of 38 days - a notably fast clearance 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: 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 Jeneric/Pentron, Inc. devices

FDA 510(k) Submission Details - K012231

510(k) Number K012231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2001
Decision Date August 23, 2001
Days to Decision 38 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
90d faster than avg
Panel avg: 128d · This submission: 38d
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 463
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K012231.
CERCON BASE
K013230 · Degussa - Ney Dental, Inc. · Oct 2001
DC - CRISTAL
K011674 · Austenal, Inc. · Sep 2001
ERIS LAYERING MATERIALS
K012174 · Ivoclar North America, Inc. · Aug 2001
CERCON CERAM
K011333 · Degussa - Ney Dental, Inc. · Aug 2001
IMAGINE H.E.
K012156 · Wieland Edelmetalle GmbH & Co. · Aug 2001
LAVA FRAME, LAVA FRAME SHADE, LAVA CERAM
K011394 · Espe Dental AG · Jun 2001