Cleared Traditional

K873882 - ALKALINER

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

K873882 · Espe GmbH (Us) · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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 47
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
IMPROVED DYCAL
K820215 · Dentsply Intl. · Mar 1982