Cleared Traditional

K120159 - BEAUTICEM SA

K120159 is an FDA 510(k) clearance for BEAUTICEM SA, manufactured by Shofu Dental Corporation. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K120159

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.

EMA Device Classification - Class 2, Special Controls

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.

Regulatory Peers - EMA Cement, Dental

All 419
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K120159.
HOFFMANN'S CEMENT (PHOSPHATE, NORMAL)
K123273 · Temrex Corp. · Dec 2012
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K120243 · GC America, Inc. · Jun 2012
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K120378 · Kuraray Medical, Inc. · Mar 2012
PANAVIA SA CEMENT AUTOMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT AUTOMIX (UNIVERSAL (A2), WHITE) PANAVIA S
K120379 · Kuraray Medical, Inc. · Mar 2012