Cleared Traditional

BISQUE ZIRCONIA BLANKS, MODEL R610191, R610210, R610211, R610205 (K091852) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K091852 · Refractron Technologies Corp. · Dental device
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Optimized for regulatory review, auditing and printing
Sep 2009
Decision
79d
Days
Class 2
Risk

K091852 is an FDA 510(k) clearance for the BISQUE ZIRCONIA BLANKS, MODEL R610191, R610210, R610211, R610205. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Refractron Technologies Corp. (Maineville, US). The FDA issued a Cleared decision on September 10, 2009 after a review of 79 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 Refractron Technologies Corp. devices

Submission Details

510(k) Number K091852 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2009
Decision Date September 10, 2009
Days to Decision 79 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
48d faster than avg
Panel avg: 127d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.

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