Cleared Traditional

K820215 - IMPROVED DYCAL

K820215 is the FDA 510(k) clearance for IMPROVED DYCAL by Dentsply Intl.. It is a Class 2 Dental device (product code EJK) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K820215 · Dentsply Intl. · Dental device
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Mar 1982
Decision
56d
Days
Class 2
Risk

K820215 is an FDA 510(k) clearance for the IMPROVED DYCAL. Classified as Liner, Cavity, Calcium Hydroxide (product code EJK), Class II - Special Controls.

Submitted by Dentsply Intl. (Mchenry, US). The FDA issued a Cleared decision on March 23, 1982 after a review of 56 days - a notably fast clearance 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: 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 Dentsply Intl. devices

Submission Details

510(k) Number K820215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1982
Decision Date March 23, 1982
Days to Decision 56 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
71d faster than avg
Panel avg: 127d · This submission: 56d
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 K820215.
ALKALINER
K873882 · Espe GmbH (Us) · Feb 1988
KERR CAVALITE
K872147 · Kerr Corporation (Danbury) · Aug 1987
KERR SEALAPEX ROOT CANAL SEALER
K841910 · Sybron Corp. · Jul 1984
MONOJECT PULP-CAPPING MATERIAL
K791088 · Sherwood Medical Co. · Oct 1979
LINER, CAVITY CALCIUM HYDROXIDE
K781688 · Kerr Corporation (Danbury) · Dec 1978