Cleared Traditional

K901870 - DEGUFILL BOND

K901870 is the FDA 510(k) clearance for DEGUFILL BOND by Degussa AG. It is a Class 2 Dental device (product code KLE) cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K901870 · Degussa AG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1990
Decision
104d
Days
Class 2
Risk

K901870 is an FDA 510(k) clearance for the DEGUFILL (R) BOND. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Degussa AG (West Germany, DE). The FDA issued a Cleared decision on August 6, 1990 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3200 - 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 Degussa AG devices

Submission Details

510(k) Number K901870 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1990
Decision Date August 06, 1990
Days to Decision 104 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 127d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KLE Agent, Tooth Bonding, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3200
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 - KLE Agent, Tooth Bonding, Resin

All 286
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K901870.
CONQUEST DIRECT FILLING COMPOSITE (DFC)
K904724 · Jeneric/Pentron, Inc. · Dec 1990
PERTAC UNIVERSAL BOND
K904289 · Espe GmbH (Us) · Nov 1990
DEGUFILL (TM) BOND
K902744 · Degussa AG · Aug 1990
DEGUFILL (R) ADHESIVE
K901871 · Degussa AG · Aug 1990
SYNTAC (DENTIN BONDING AGENT)
K901913 · Ivoclar North America, Inc. · Jun 1990
PERTAC BOND
K900558 · Espe GmbH (Us) · Apr 1990