Cleared Traditional

PERIACRYL (K974097) - FDA 510(k) Clearance

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

K974097 · Blacklock Medical Products, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1998
Decision
161d
Days
Class 2
Risk

K974097 is an FDA 510(k) clearance for the PERIACRYL. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Blacklock Medical Products, Inc. (Delta, CA). The FDA issued a Cleared decision on April 9, 1998 after a review of 161 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 Blacklock Medical Products, Inc. devices

Submission Details

510(k) Number K974097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1997
Decision Date April 09, 1998
Days to Decision 161 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 127d · This submission: 161d
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
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K002452 · 3M Company · Sep 2000
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K981965 · Dentsply Intl. · Jul 1998
ADHESIVE HYBRID IONOMER CEMENT
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3M DENT SYSTEM II PLUS
K973961 · 3M Company · Dec 1997
3M VITREBOND LIGHT CURE GLASS IONOMER/BASE
K962065 · 3M Company · Jul 1996