Cleared Traditional

CHEMFIL II CAPS (K901524) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

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 79
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K901524.
VENEER CEMENT
K923328 · Dentsply Intl. · Sep 1992
VLC GLASS IONOMER
K913836 · Dentsply Intl. · Oct 1991
3M LUTING CEMENT, PASTE A AND B
K911842 · 3M Company · Jun 1991
3M LUTING CEMENT - PASTE A AND PASTE B
K902041 · 3M Company · Jun 1990
BIOMER(R) F COMPOSITE LUTING CEMENT
K896340 · Dentsply Intl. · May 1990
TEMPORARY DENTAL CEMENT
K895487 · Dentsply Intl. · Apr 1990