Cleared Traditional

PREVISION CHEM (K010541) - FDA 510(k) Clearance

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

K010541 · Heraeus Kulzer, Inc. · Dental device
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Jul 2001
Decision
158d
Days
Class 2
Risk

K010541 is an FDA 510(k) clearance for the PREVISION CHEM. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Heraeus Kulzer, Inc. (South Bend, US). The FDA issued a Cleared decision on July 31, 2001 after a review of 158 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 Heraeus Kulzer, Inc. devices

Submission Details

510(k) Number K010541 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2001
Decision Date July 31, 2001
Days to Decision 158 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
31d slower than avg
Panel avg: 127d · This submission: 158d
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 80
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K010541.
CALIBRA CEMENT
K040906 · Dentsply Intl. · Jun 2004
INTEGRITY TEMPORARY CEMENT
K040895 · Dentsply Intl. · May 2004
RELYX RMGIP
K022476 · 3M Company · Aug 2002
GILB, MODEL 8010
K011200 · 3M Company · Jun 2001
DYRACT CEM LCI COMPOMER
K003921 · Dentsply Intl. · Jan 2001
3M RELY X VENEER CEMENT TRY-IN PASTER
K002452 · 3M Company · Sep 2000