Cleared Traditional

K821326 - CUTTER BOND POLYCARBOXYLATE CEMENT

K821326 is an FDA 510(k) clearance for CUTTER BOND POLYCARBOXYLATE CEMENT, manufactured by Cutter Laboratories, Inc.. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K821326 · Cutter Laboratories, Inc. · Dental device
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May 1982
Decision
24d
Days
Class 2
Risk

K821326 is an FDA 510(k) clearance for the CUTTER BOND POLYCARBOXYLATE CEMENT. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Cutter Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 28, 1982 after a review of 24 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cutter Laboratories, Inc. devices

FDA 510(k) Submission Details - K821326

510(k) Number K821326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1982
Decision Date May 28, 1982
Days to Decision 24 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
103d faster than avg
Panel avg: 127d · This submission: 24d
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 299
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K821326.
GLAS IONOMER CEMENT
K841195 · Shofu Dental Corp. · May 1984
HY-BOND ZINC OXIDE EUGENOL TEMP.
K841196 · Shofu Dental Corp. · May 1984
EVERBOND GLASS IONOMER CEMENT
K823795 · Sybron Corp. · Jan 1983
CUTTERBOND ZINC PHOSPHATE CEMENT
K813532 · Cutter Laboratories, Inc. · Mar 1982
CHEMFIL
K812858 · Dentsply Intl. · Dec 1981
HY-BOND POLYCARBOXYLATE CEMENT
K810764 · Shofu Dental Corp. · Jun 1981