Cleared Traditional

K922721 - VLC DYCAL II

K922721 is an FDA 510(k) clearance for VLC DYCAL II, manufactured by Dentsply Intl.. The device is a Class 2 Dental device with product code EJK cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K922721 · Dentsply Intl. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1992
Decision
48d
Days
Class 2
Risk

K922721 is an FDA 510(k) clearance for the VLC DYCAL II. Classified as Liner, Cavity, Calcium Hydroxide (product code EJK), Class II - Special Controls.

Submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on July 23, 1992 after a review of 48 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

FDA 510(k) Submission Details - K922721

510(k) Number K922721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1992
Decision Date July 23, 1992
Days to Decision 48 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 127d · This submission: 48d
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 K922721.
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SEPTOCAL CAVITY LINER
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IONOSEAL
K912495 · Voco GmbH · Jul 1991