Cleared Traditional

K974097 - PERIACRYL

K974097 is an FDA 510(k) clearance for PERIACRYL, manufactured by Blacklock Medical Products, Inc.. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 161-day FDA review.

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

FDA 510(k) Submission Details - K974097

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
Combination Product No
PCCP Authorized No
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.

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 386
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K974097.
JUMBO GLASS IONOMER CEMENT
K980568 · Centrix, Inc. · Apr 1998
PROTEC CEM.
K980922 · Ivoclar North America, Inc. · Apr 1998
FUJI I
K980695 · GC America, Inc. · Apr 1998
OCTYLDENT (2-OCTYL CYANOACRYLATE), 02A01
K980159 · Closure Medical Corp. · Apr 1998
FUJI II
K980682 · GC America, Inc. · Apr 1998
CLEARFIL DC CEMENT
K980232 · Kuraray Company, Ltd. · Feb 1998