Cleared Traditional

K013555 - SCI-PHARM POST SECURE

K013555 is an FDA 510(k) clearance for SCI-PHARM POST SECURE, manufactured by Scientific Pharmaceuticals, Inc.. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K013555

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.

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 429
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K013555.
PULPDENT POST CEMENT
K020481 · Pulpdent Corporation · Apr 2002
UNICEM
K020256 · 3M Espe AG Dental Products · Mar 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