Cleared Traditional

K931867 - ULTRA-ETCH ENAMEL PREPARATION PRODUCT LINE

K931867 is an FDA 510(k) clearance for ULTRA-ETCH ENAMEL PREPARATION PRODUCT LINE, manufactured by Ultradent Products, Inc.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K931867 · Ultradent Products, Inc. · Dental device
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Sep 1993
Decision
148d
Days
Class 2
Risk

K931867 is an FDA 510(k) clearance for the ULTRA-ETCH ENAMEL PREPARATION PRODUCT LINE. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on September 9, 1993 after a review of 148 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 Ultradent Products, Inc. devices

FDA 510(k) Submission Details - K931867

510(k) Number K931867 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1993
Decision Date September 09, 1993
Days to Decision 148 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
21d slower than avg
Panel avg: 127d · This submission: 148d
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 782
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K931867.
CONQUEST CRYSTAL
K932154 · Jeneric/Pentron, Inc. · Sep 1993
AMELOGEN RESTORATIVE MATERIALS
K932227 · Ultradent Products, Inc. · Sep 1993
PULPDENT 2.5% NITRIC ACID ETCHANT
K932793 · Pulpdent Corp. · Sep 1993
PULPDENT MALEIC ACID ETCHANTS
K932792 · Pulpdent Corp. · Sep 1993
VLC DR MATERIAL
K932395 · Dentsply Intl. · Aug 1993
BISCO D/C CORE COMPOSITE
K930405 · Bisco, Inc. · Aug 1993