Cleared Traditional

K912495 - IONOSEAL

K912495 is an FDA 510(k) clearance for IONOSEAL, manufactured by Voco GmbH. The device is a Class 2 Dental device with product code EJK cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K912495 · Voco GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1991
Decision
55d
Days
Class 2
Risk

K912495 is an FDA 510(k) clearance for the IONOSEAL. Classified as Liner, Cavity, Calcium Hydroxide (product code EJK), Class II - Special Controls.

Submitted by Voco GmbH (Denver, US). The FDA issued a Cleared decision on July 30, 1991 after a review of 55 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 Voco GmbH devices

FDA 510(k) Submission Details - K912495

510(k) Number K912495 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1991
Decision Date July 30, 1991
Days to Decision 55 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 127d · This submission: 55d
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 K912495.
VLC DYCAL II
K922721 · Dentsply Intl. · Jul 1992
SEPTOCALCINE ULTRA
K920692 · Specialites Septodont · Apr 1992
SEPTOCAL CAVITY LINER
K913574 · Specialites Septodont · Sep 1991
VLC GLASS IONOMER LINER
K911244 · Dentsply Intl. · Jun 1991
PHOTAC-BOND
K904096 · Espe GmbH (Us) · Nov 1990
PHOTAC-BOND APLICAP
K904097 · Espe GmbH (Us) · Nov 1990