Cleared Traditional

K901870 - DEGUFILL (R) BOND

K901870 is an FDA 510(k) clearance for DEGUFILL BOND, manufactured by Degussa AG. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K901870

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.

KLE Device Classification - Class 2, Special Controls

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 380
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
PALFIQUE LIGHT BONDING AGENT
K897009 · Tokuyama America, Inc. · May 1990