Cleared Traditional

K943642 - HERCULITE XR & XRV

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

K943642 · Sybron Dental Specialties, Inc. · Dental device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K943642

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.

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 761
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
ALPHA-DENT C-R(R) HYBRID TYPE II COMPOSITE RESIN
K942767 · Wallace A. Erickson & Co. · Jul 1994
SDI COMPOSTIES
K941899 · Southern Dental Industries, Inc. · Jul 1994
CAULK TOOTH CONDITIONER GEL AND SYRINGE
K942031 · Dentsply Intl. · Jun 1994