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) Official FDA 510(k) Summary (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.

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
181d slower than avg
Panel avg: 128d · 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 482
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K100794.
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K102305 · Hass Corp. · Dec 2010
ZIECON DISC WITH COLLAR FOR CAD/CAM MODEL ZD810-26, ZIECON BLOCK FOR MOM MODEL ZB763812-20, ZB653012-21, ZB402012-20, ZI
K102538 · Jyoti Ceramic Industries Private Limited · Oct 2010
BK BLANK MODEL 20,40,65,90
K101875 · Bk Medent Co., Ltd. · Aug 2010
K100794 · FLUORCANASITE DENTAL CERAMIC
Download PDF FDA Summary Dr Sarah Pollington