Cleared Traditional

K900301 - NOVUS BONDING AGENT

K900301 is an FDA 510(k) clearance for NOVUS BONDING AGENT, manufactured by The Hygenic Corp.. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K900301 · The Hygenic Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1990
Decision
113d
Days
Class 2
Risk

K900301 is an FDA 510(k) clearance for the NOVUS BONDING AGENT. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by The Hygenic Corp. (Akron, US). The FDA issued a Cleared decision on May 15, 1990 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 872.3760 - 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 The Hygenic Corp. devices

FDA 510(k) Submission Details - K900301

510(k) Number K900301 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1990
Decision Date May 15, 1990
Days to Decision 113 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
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.

EBI Device Classification - Class 2, Special Controls

Product Code EBI Resin, Denture, Relining, Repairing, Rebasing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3760
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 - EBI Resin, Denture, Relining, Repairing, Rebasing

All 260
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K900301.
PALADON(R) 65
K901789 · Kulzer, Inc. · Jun 1990
PALFIQUE LIGHT LINER
K896980 · Tokuyama America, Inc. · May 1990
TOKUSO REBASE
K896981 · Tokuyama America, Inc. · May 1990
SR-IVOCAP
K896130 · Ivoclar North America, Inc. · Apr 1990
SR-IVOSEAL
K896139 · Ivoclar North America, Inc. · Apr 1990
ORTHO-KEV APPLIANCE REINFORCING SYSTEM
K895714 · American Orthodontics · Dec 1989