Cleared Traditional

COE PAK AUTO MIX, REGULAR OR HARD SET (K881422) - FDA 510(k) Clearance

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

K881422 · Coe Laboratories, Inc. · Dental device
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Oct 1988
Decision
209d
Days
Class 2
Risk

K881422 is an FDA 510(k) clearance for the COE PAK AUTO MIX, REGULAR OR HARD SET. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Coe Laboratories, Inc. (Alsip, US). The FDA issued a Cleared decision on October 31, 1988 after a review of 209 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 Coe Laboratories, Inc. devices

Submission Details

510(k) Number K881422 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1988
Decision Date October 31, 1988
Days to Decision 209 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d slower than avg
Panel avg: 127d · This submission: 209d
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 K881422.
3M LUTING CEMENT - PASTE A AND PASTE B
K902041 · 3M Company · Jun 1990
BIOMER(R) F COMPOSITE LUTING CEMENT
K896340 · Dentsply Intl. · May 1990
TEMPORARY DENTAL CEMENT
K895487 · Dentsply Intl. · Apr 1990
CEMENT LINER
K874945 · Dentsply Intl. · Feb 1988
LIGHT-CURED PERIODONTAL DRESSING
K864720 · Dentsply Intl. · Apr 1987
BONDEX* GLASS IONOMER CEMENT
K870211 · Johnson & Johnson Professionals, Inc. · Mar 1987