Cleared Traditional

K813532 - CUTTERBOND ZINC PHOSPHATE CEMENT

K813532 is an FDA 510(k) clearance for CUTTERBOND ZINC PHOSPHATE 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 75-day FDA review.

K813532 · Cutter Laboratories, Inc. · Dental device
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Mar 1982
Decision
75d
Days
Class 2
Risk

K813532 is an FDA 510(k) clearance for the CUTTERBOND ZINC PHOSPHATE 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 March 2, 1982 after a review of 75 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 - K813532

510(k) Number K813532 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1981
Decision Date March 02, 1982
Days to Decision 75 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
52d faster than avg
Panel avg: 127d · This submission: 75d
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 K813532.
HY-BOND ZINC OXIDE EUGENOL TEMP.
K841196 · Shofu Dental Corp. · May 1984
EVERBOND GLASS IONOMER CEMENT
K823795 · Sybron Corp. · Jan 1983
CUTTER BOND POLYCARBOXYLATE CEMENT
K821326 · Cutter Laboratories, Inc. · May 1982
CHEMFIL
K812858 · Dentsply Intl. · Dec 1981
HY-BOND POLYCARBOXYLATE CEMENT
K810764 · Shofu Dental Corp. · Jun 1981
HY-BOND ZINC PHOSPHATE CEMENT
K810765 · Shofu Dental Corp. · Jun 1981