Cleared Traditional

K100794 - FLUORCANASITE DENTAL CERAMIC

K100794 is an FDA 510(k) clearance for FLUORCANASITE DENTAL CERAMIC, manufactured by Dr Sarah Pollington. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 309-day FDA review.

K100794 · Dr Sarah Pollington · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2011
Decision
309d
Days
Class 2
Risk

K100794 is an FDA 510(k) clearance for the FLUORCANASITE DENTAL CERAMIC. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Dr Sarah Pollington (Dallas, US). The FDA issued a Cleared decision on January 25, 2011 after a review of 309 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Dr Sarah Pollington devices

FDA 510(k) Submission Details - K100794

510(k) Number K100794 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2010
Decision Date January 25, 2011
Days to Decision 309 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
182d slower than avg
Panel avg: 127d · This submission: 309d
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 304
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K100794.
IPS E.MAX CAD CRYSTALL / CONNECT AND IPS E.MAX CAD CRYSTAL / ADD-ON CONNECT (FOR CAD-ON TECHNIQUE)
K103556 · Ivoclar Vivadent, Inc. · Apr 2011
ZENOFLEX DIMENSION
K103773 · Wieland Dental + Technik GmbH & Co. KG · Mar 2011
ZENOSTAR MAGIC GLAZE
K103494 · Wieland Dental + Technik GmbH & Co. KG · Feb 2011
NOBELPROCERA IPS E.MAX CROWN
K100512 · Nobel Biocare AB · Aug 2010
OBSIDIAN CERAMIC BLOCKS
K100781 · Prismatik Dentalcraft, Inc. · Jun 2010
VINTAGE MP
K093559 · Shofu Dental Corp. · Mar 2010