Cleared Traditional

K904135 - FOUNDATION HYBRID COMPOSITE

K904135 is an FDA 510(k) clearance for FOUNDATION HYBRID COMPOSITE, manufactured by Nulite Systems Research. The device is a Class 2 Dental device with product code EBD cleared through the Traditional 510(k) pathway after a 251-day FDA review.

K904135 · Nulite Systems Research · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1991
Decision
251d
Days
Class 2
Risk

K904135 is an FDA 510(k) clearance for the FOUNDATION HYBRID COMPOSITE. Classified as Coating, Filling Material, Resin (product code EBD), Class II - Special Controls.

Submitted by Nulite Systems Research (Australia, AU). The FDA issued a Cleared decision on May 15, 1991 after a review of 251 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3310 - 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 Nulite Systems Research devices

FDA 510(k) Submission Details - K904135

510(k) Number K904135 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1990
Decision Date May 15, 1991
Days to Decision 251 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
124d slower than avg
Panel avg: 127d · This submission: 251d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBD Device Classification - Class 2, Special Controls

Product Code EBD Coating, Filling Material, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3310
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 - EBD Coating, Filling Material, Resin

All 47
Devices cleared under the same product code (EBD) and FDA review panel - the closest regulatory comparables to K904135.
CORE-IDE
K984037 · Roydent Dental Products, Inc. · Feb 1999
FLOWABLE HYBRID
K980298 · Cosmedent, Inc. · Mar 1998
RENAMEL FLOWABLE COMPOSITE
K974494 · Cosmedent, Inc. · Feb 1998
NO-STICK COMPOSITE INSTRUMENT DIP
K901050 · Pulpdent Corp. · Apr 1990
3M ESTHETIC DESIGN SYSTEM (TINTS & MASKING AGENTS)
K862590 · 3M Company · Jul 1986
AUSTENAL DENTAL COMPOSITE RESIN
K854957 · Austenal Dental, Inc. · Jan 1986