Cleared Traditional

K091019 - SPEEDCEM

K091019 is the FDA 510(k) clearance for SPEEDCEM by Ivoclar Vivadent, Inc.. It is a Class 2 Dental device (product code EMA) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K091019 · Ivoclar Vivadent, Inc. · Dental device
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Jun 2009
Decision
56d
Days
Class 2
Risk

K091019 is an FDA 510(k) clearance for the SPEEDCEM. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Ivoclar Vivadent, Inc. (Amherst, US). The FDA issued a Cleared decision on June 4, 2009 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3275 - 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 Ivoclar Vivadent, Inc. devices

Submission Details

510(k) Number K091019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2009
Decision Date June 04, 2009
Days to Decision 56 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 127d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EMA Cement, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3275
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.