Cleared Traditional

K943642 - HERCULITE XR & XRV

K943642 is the FDA 510(k) clearance for HERCULITE XR & XRV by Sybron Dental Specialties, Inc.. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K943642 · Sybron Dental Specialties, Inc. · Dental device
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Optimized for regulatory review, auditing and printing
Nov 1994
Decision
113d
Days
Class 2
Risk

K943642 is an FDA 510(k) clearance for the HERCULITE XR & XRV. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Sybron Dental Specialties, Inc. (Glendora, US). The FDA issued a Cleared decision on November 17, 1994 after a review of 113 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 Sybron Dental Specialties, Inc. devices

Submission Details

510(k) Number K943642 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1994
Decision Date November 17, 1994
Days to Decision 113 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
14d faster than avg
Panel avg: 127d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 479
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K943642.
PULPDENT MICROFILLED ANTERIOR COMPOSITE
K945058 · Pulpdent Corp. · Dec 1994
PULPDENT CERVICAL RESTORATIVE
K945113 · Pulpdent Corp. · Dec 1994
PRODIGY
K944659 · Sybron Dental Specialties, Inc. · Dec 1994
CAULK TOOTH CONDITIONER GEL AND SYRINGE
K942031 · Dentsply Intl. · Jun 1994
PENT CORE PLUS (PASTE-PASTE)
K941373 · Jeneric/Pentron, Inc. · May 1994
CONQUEST SMOOTH TOUCH
K941377 · Jeneric/Pentron, Inc. · May 1994