Cleared Traditional

K901524 - CHEMFIL II CAPS

K901524 is an FDA 510(k) clearance for CHEMFIL II CAPS, manufactured by Dentsply Intl.. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K901524 · Dentsply Intl. · Dental device
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Sep 1990
Decision
170d
Days
Class 2
Risk

K901524 is an FDA 510(k) clearance for the CHEMFIL II CAPS. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on September 19, 1990 after a review of 170 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 Dentsply Intl. devices

FDA 510(k) Submission Details - K901524

510(k) Number K901524 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1990
Decision Date September 19, 1990
Days to Decision 170 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 127d · This submission: 170d
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 433
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K901524.
TEETHMATE-F
K910424 · Kuraray Co. · Apr 1991
TEMPORARY DENTAL CEMENT
K904034 · Medical Device Inspection Co., Inc. · Dec 1990
CEMPER
K904024 · Scientific Pharmaceuticals, Inc. · Nov 1990
SURGI PAK NE AND COCOMENT EUGENAL FREE PASTE SYST
K902817 · Confi-Dental Products Co. · Aug 1990
POST CEMENT (DENTAL COMPOSITE)
K902894 · Medical Device Inspection Co., Inc. · Aug 1990
AHYDRON DENTAL CLEANING AGENT
K902052 · Ivoclar North America, Inc. · Jul 1990