Cleared Traditional

K931502 - VIVAGLASS LINER

K931502 is the FDA 510(k) clearance for VIVAGLASS LINER by Ivoclar North America, Inc.. It is a Class 2 Dental device (product code EJK) cleared through the Traditional 510(k) pathway after a 119-day FDA review.

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
Combination Product No
PCCP Authorized No
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 47
Devices cleared under the same product code (EJK) and FDA review panel - the closest regulatory comparables to K931502.
CALCIUM HYDROXIDE PASTE
K943372 · Ultradent Products, Inc. · Sep 1994
NEEDLETUBE SYRINGE CARTRTIDGE
K933507 · Centrix, Inc. · Jan 1994
STERIBASE (ACCUBASE)
K933999 · Centrix, Inc. · Jan 1994
CALCICUR
K926419 · Voco GmbH · Mar 1993
LIGHT CURE DENTIN AND LINER BASE PRODUCT LINE
K921408 · Ultradent Products, Inc. · Nov 1992
CALCIMOL LC
K924182 · Voco GmbH · Oct 1992