Cleared Traditional

K913836 - VLC GLASS IONOMER

K913836 is an FDA 510(k) clearance for VLC GLASS IONOMER, manufactured by Dentsply Intl.. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K913836 · Dentsply Intl. · Dental device
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Optimized for regulatory review, auditing and printing
Oct 1991
Decision
52d
Days
Class 2
Risk

K913836 is an FDA 510(k) clearance for the VLC GLASS IONOMER. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on October 17, 1991 after a review of 52 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 Dentsply Intl. devices

FDA 510(k) Submission Details - K913836

510(k) Number K913836 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1991
Decision Date October 17, 1991
Days to Decision 52 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 127d · This submission: 52d
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 433
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K913836.
CAVITY VARNISH PRODUCT
K914324 · Confi-Dental Products Co. · Dec 1991
FUJI II LC
K913884 · G-C Intl. Corp. · Oct 1991
F21(R) DENTAL CEMENT
K914073 · Voco GmbH · Oct 1991
AUTOPACK NON-EUGENOL PERIODONTAL DRESSING
K913572 · Specialites Septodont · Oct 1991
IONOBOND
K912497 · Voco GmbH · Jul 1991
3M LUTING CEMENT, PASTE A AND B
K911842 · 3M Company · Jun 1991