Cleared Traditional

K120159 - BEAUTICEM SA

K120159 is the FDA 510(k) clearance for BEAUTICEM SA by Shofu Dental Corporation. It is a Class 2 Dental device (product code EMA) cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K120159 · Shofu Dental Corporation · Dental device
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Jun 2012
Decision
151d
Days
Class 2
Risk

K120159 is an FDA 510(k) clearance for the BEAUTICEM SA. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Shofu Dental Corporation (San Marcos, US). The FDA issued a Cleared decision on June 18, 2012 after a review of 151 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Shofu Dental Corporation devices

Submission Details

510(k) Number K120159 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 2012
Decision Date June 18, 2012
Days to Decision 151 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
24d slower than avg
Panel avg: 127d · This submission: 151d
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.

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All 253
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