Cleared Traditional

K912497 - IONOBOND

K912497 is an FDA 510(k) clearance for IONOBOND, manufactured by Voco GmbH. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K912497 · Voco GmbH · Dental device
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Jul 1991
Decision
55d
Days
Class 2
Risk

K912497 is an FDA 510(k) clearance for the IONOBOND. Classified as Cement, Dental (product code EMA), 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 872.3275 - 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 - K912497

510(k) Number K912497 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.

EMA Device Classification - Class 2, Special Controls

Product Code EMA Cement, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3275
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 - EMA Cement, Dental

All 421
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K912497.
F21(R) DENTAL CEMENT
K914073 · Voco GmbH · Oct 1991
VLC GLASS IONOMER
K913836 · Dentsply Intl. · Oct 1991
AUTOPACK NON-EUGENOL PERIODONTAL DRESSING
K913572 · Specialites Septodont · Oct 1991
3M LUTING CEMENT, PASTE A AND B
K911842 · 3M Company · Jun 1991
SILICOATER MD
K910719 · Kulzer, Inc. · Apr 1991
TEETHMATE-F
K910424 · Kuraray Co. · Apr 1991