Cleared Traditional

K013555 - SCI-PHARM POST SECURE

K013555 is the FDA 510(k) clearance for SCI-PHARM POST SECURE by Scientific Pharmaceuticals, Inc.. It is a Class 2 Dental device (product code EMA) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K013555 · Scientific Pharmaceuticals, Inc. · Dental device
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Jan 2002
Decision
90d
Days
Class 2
Risk

K013555 is an FDA 510(k) clearance for the SCI-PHARM POST SECURE. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Scientific Pharmaceuticals, Inc. (Pomona, US). The FDA issued a Cleared decision on January 23, 2002 after a review of 90 days - within the typical 510(k) review window.

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 Scientific Pharmaceuticals, Inc. devices

Submission Details

510(k) Number K013555 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 2001
Decision Date January 23, 2002
Days to Decision 90 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
37d faster than avg
Panel avg: 127d · This submission: 90d
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.

Regulatory Peers - EMA Cement, Dental

All 284
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K013555.
GC ELITE CEMENT 100
K021038 · GC America, Inc. · May 2002
PULPDENT POST CEMENT
K020481 · Pulpdent Corporation · Apr 2002
GC FUJI LINING LC PASTE PAK
K020117 · GC America, Inc. · Feb 2002
NEXUS 2 CLEAR
K013609 · Sybron Dental Specialties, Inc. · Jan 2002
FUJI VII CAPSULE
K013198 · GC America, Inc. · Oct 2001
NEXUS 2 MODIFIED
K013008 · Sybron Dental Specialties, Inc. · Oct 2001