Cleared Traditional

K873882 - ALKALINER

K873882 is an FDA 510(k) clearance for ALKALINER, manufactured by Espe GmbH (Us). The device is a Class 2 Dental device with product code EJK cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K873882 · Espe GmbH (Us) · Dental device
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Feb 1988
Decision
156d
Days
Class 2
Risk

K873882 is an FDA 510(k) clearance for the ALKALINER. Classified as Liner, Cavity, Calcium Hydroxide (product code EJK), Class II - Special Controls.

Submitted by Espe GmbH (Us) (Lake Worth, US). The FDA issued a Cleared decision on February 26, 1988 after a review of 156 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3250 - 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 Espe GmbH (Us) devices

FDA 510(k) Submission Details - K873882

510(k) Number K873882 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1987
Decision Date February 26, 1988
Days to Decision 156 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
29d slower than avg
Panel avg: 127d · This submission: 156d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EJK Device Classification - Class 2, Special Controls

Product Code EJK Liner, Cavity, Calcium Hydroxide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3250
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 - EJK Liner, Cavity, Calcium Hydroxide

All 60
Devices cleared under the same product code (EJK) and FDA review panel - the closest regulatory comparables to K873882.
INTERFACE - CAVITY LINER
K897130 · Scientific Pharmaceuticals, Inc. · Mar 1990
BASIC CALCIUM HYDROXIDE LINER
K896529 · Ivoclar North America, Inc. · Jan 1990
GLASS IONOMER BASE
K882751 · Dentsply Intl. · Nov 1988
KERR CAVALITE
K872147 · Kerr Corporation (Danbury) · Aug 1987
KERR SEALAPEX ROOT CANAL SEALER
K841910 · Sybron Corp. · Jul 1984
NU-CAP CALCIUM HYDROX. PULP CAPPING
K831575 · Coe Laboratories, Inc. · Jun 1983