Cleared Traditional

K974390 - GLUMA ONE BOND

K974390 is an FDA 510(k) clearance for GLUMA ONE BOND, manufactured by Heraeus Kulzer, Inc.. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K974390 · Heraeus Kulzer, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
75d
Days
Class 2
Risk

K974390 is an FDA 510(k) clearance for the GLUMA ONE BOND. 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 4, 1998 after a review of 75 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

FDA 510(k) Submission Details - K974390

510(k) Number K974390 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1997
Decision Date February 04, 1998
Days to Decision 75 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 127d · This submission: 75d
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 317
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K974390.
SOLOBOND M
K980539 · Voco GmbH · Mar 1998
PREPQUICK
K974786 · Ultradent Products, Inc. · Mar 1998
D/SENSE-T
K973285 · Centrix, Inc. · Feb 1998
PQ 1
K974283 · Ultradent Products, Inc. · Jan 1998
AMERICAN DENTAL PRODUCTS HB-35 DESENSITIZER WITH FLUORIDE
K973185 · American Dental Products, Inc. · Nov 1997
2 BOND 2
K971733 · Heraeus Kulzer, Inc. · Oct 1997