Cleared Traditional

VIVAGLASS LINER (K931502) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K931502 · Ivoclar North America, Inc. · Dental device
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Jul 1993
Decision
119d
Days
Class 2
Risk

K931502 is an FDA 510(k) clearance for the VIVAGLASS LINER. Classified as Liner, Cavity, Calcium Hydroxide (product code EJK), Class II - Special Controls.

Submitted by Ivoclar North America, Inc. (Amherst, US). The FDA issued a Cleared decision on July 22, 1993 after a review of 119 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Ivoclar North America, Inc. devices

Submission Details

510(k) Number K931502 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 1993
Decision Date July 22, 1993
Days to Decision 119 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
8d faster than avg
Panel avg: 127d · This submission: 119d
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 12
Devices cleared under the same product code (EJK) and FDA review panel - the closest regulatory comparables to K931502.
LC ResinCal PC
K202413 · S&C Polymer Silicon- Und Composite Spezialitaten GmbH · Nov 2020
Parkell Desensitizer Gel
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TheraCal DC
K180344 · Bisco, Inc. · Apr 2018
VLC DYCAL II
K922721 · Dentsply Intl. · Jul 1992
VLC GLASS IONOMER LINER
K911244 · Dentsply Intl. · Jun 1991
GLASS IONOMER BASE
K882751 · Dentsply Intl. · Nov 1988