Cleared Traditional

K932395 - VLC DR MATERIAL

K932395 is an FDA 510(k) clearance for VLC DR MATERIAL, manufactured by Dentsply Intl.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K932395 · Dentsply Intl. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1993
Decision
99d
Days
Class 2
Risk

K932395 is an FDA 510(k) clearance for the VLC DR MATERIAL. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on August 25, 1993 after a review of 99 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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 Dentsply Intl. devices

FDA 510(k) Submission Details - K932395

510(k) Number K932395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1993
Decision Date August 25, 1993
Days to Decision 99 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 127d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBF Device Classification - Class 2, Special Controls

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 - EBF Material, Tooth Shade, Resin

All 800
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K932395.
PULPDENT 2.5% NITRIC ACID ETCHANT
K932793 · Pulpdent Corp. · Sep 1993
ULTRA-ETCH ENAMEL PREPARATION PRODUCT LINE
K931867 · Ultradent Products, Inc. · Sep 1993
PULPDENT MALEIC ACID ETCHANTS
K932792 · Pulpdent Corp. · Sep 1993
BISCO D/C CORE COMPOSITE
K930405 · Bisco, Inc. · Aug 1993
VARIOLINK
K931309 · Ivoclar North America, Inc. · Jul 1993
CHARISMA -- MODIFIED
K932013 · Heraeus Kulzer, Inc. · Jul 1993