Cleared Traditional

K945364 - DYRACT(TM) MATERIAL

K945364 is an FDA 510(k) clearance for DYRACT(TM) MATERIAL, manufactured by Denstply Detrey-Dedent. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K945364 · Denstply Detrey-Dedent · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1994
Decision
69d
Days
Class 2
Risk

K945364 is an FDA 510(k) clearance for the DYRACT(TM) MATERIAL. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Denstply Detrey-Dedent (York, US). The FDA issued a Cleared decision on December 29, 1994 after a review of 69 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Denstply Detrey-Dedent devices

FDA 510(k) Submission Details - K945364

510(k) Number K945364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1994
Decision Date December 29, 1994
Days to Decision 69 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 127d · This submission: 69d
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 810
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K945364.
DYRACT II RESTORATIVE
K950991 · Dentsply Intl. · Mar 1995
THERMORESIN LC II
K942993 · GC America, Inc. · Feb 1995
CYRSTALLINE L3 MULTI-USE HYBRID COMPOSITE
K946307 · Confi-Dental Products Co. · Jan 1995
OPTIGUARD
K945539 · Sybron Dental Specialties, Inc. · Dec 1994
TOTAL ETCH GEL
K945769 · Dentsply Intl. · Dec 1994
PULPDENT HARDSHELL
K945173 · Pulpdent Corp. · Dec 1994