Cleared Traditional

K896382 - MODIFIED GLUMA BONDING SYSTEM

K896382 is the FDA 510(k) clearance for MODIFIED GLUMA BONDING SYSTEM by Heraeus Kulzer, Inc.. It is a Class 2 Dental device (product code KLE) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K896382 · Heraeus Kulzer, Inc. · Dental device
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Feb 1990
Decision
87d
Days
Class 2
Risk

K896382 is an FDA 510(k) clearance for the MODIFIED GLUMA BONDING SYSTEM. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Heraeus Kulzer, Inc. (South Bend, US). The FDA issued a Cleared decision on February 1, 1990 after a review of 87 days - a notably fast clearance cycle.

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: 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 Heraeus Kulzer, Inc. devices

Submission Details

510(k) Number K896382 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1989
Decision Date February 01, 1990
Days to Decision 87 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
40d faster than avg
Panel avg: 127d · This submission: 87d
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 297
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K896382.
ALL-BOND DENTIN BONDING SYSTEM
K897020 · Bisco, Inc. · Mar 1990
9.6% HYDROFLUORIC ACID GEL
K896655 · Pulpdent Corp. · Feb 1990
SILANE
K896659 · Pulpdent Corp. · Feb 1990
RESTOBOND 3/DENTIN-ENAMEL BONDING AGENT
K894315 · Lee Pharmaceuticals · Oct 1989
DENTIN BONDING SYSTEM
K894994 · Cosmedent, Inc. · Oct 1989
DENTIN PRIMER
K891455 · Dentsply Intl. · May 1989